IV Guideline
1 Introduction and definitions
Female pelvic organ prolapse or female genital prolapse is a common condition in women;
the incidence of pelvic organ prolapse is increasing due to the overall rise in life
expectancy. Therapy options consist of a number of conservative or surgical approaches.
The aim of this guideline is to provide an evidence-based description of the diagnosis
and the conservative and surgical therapy of female pelvic organ prolapse in women
aged over 18 years. National and international socio-economic conditions were also
taken into consideration.
The recommendations for the diagnosis and treatment of female pelvic organ prolapse
are based on an extensive, systematic review and evaluation of the recent literature
which also took account of the experiences and specific conditions in Germany, Austria
and Switzerland. The guideline is an update of the guideline published in 2008 and
has also included the warnings of the American Food and Drug Administration (FDA),
including the last notification published in 2011 (http://www.fda.gov/medicaldevices/safety/alertsandnotices/publichealthnotifications/ucm061976.htm) which led to substantive changes in prolapse surgeries using mesh implants. General
dissatisfaction with the anatomical outcomes following standard prolapse surgery resulted
in a significant increase in the use of various biological and synthetic implants
(meshes). Following the second warning by the FDA, some of industrially produced mesh
kits which were still available five years ago have since been withdrawn from the
market (e.g. Prolift®, Prosima®, Avaulta®, Perigee® in the USA, in the meantime also
Elevate®). The material properties (macropores > 75 µm and lightweight ≤ 32 g/m2 meshes, no multifilament absorbable or non-absorbable materials) of the new generation
of meshes have been improved or amended, and the required apical fixation has now
also been integrated.
Female pelvic organ prolapse is often associated with stress urinary incontinence.
The symptoms of stress urinary incontinence have been defined as a leakage or loss
of urine in response to physical activities such as coughing or lifting. If urine
leakage during coughing only occurs after repositioning of the prolapse during clinical
examination or after insertion of a pessary, it is referred to as occult stress incontinence. In addition to repair of the prolapse, the simultaneous protection or recreation
of continence is a special aspect which is also discussed in this guideline.
2 Diagnosis
2.1 Medical history
A standardized questionnaire should be used to record the patientʼs specific medical
history of pelvic floor symptoms. It is recommended that validated questionnaires
which also include an assessment of the patientʼs quality of life should be used to
assess quality control and in all studies [1]. Validated pelvic floor questionnaires available in German include the questionnaire
of the International Consultation on Incontinence (ICI; www.iciq.net), the German version of the Kingʼs Health Questionnaire [2], the German version of the “urinary incontinence-specific measure of quality of
life” (I-QOL) [3] and the German Pelvic Floor Questionnaire (German version of the Australian Pelvic
Floor Questionnaire) [4], for which a validated post-therapeutic follow-up module is also available [5].
2.2 Clinical examination
In addition to standard inspection of the external genitalia, assessment of the prolapse
is done using a split speculum, and the evaluation must include coughing or pushing.
The extent of prolapse must be documented separately for the anterior (bladder, anterior
vaginal walls), middle (cervix or uterine stump) and posterior compartment. Quantification
of the pelvic organ prolapse using the ICS/IUGA standard terminology is internationally
recommended [6], [7]. This should then be followed by a cough stress test carried out both without repositioning
and after repositioning of the prolapse, e.g. with a speculum, pessary, swab or digitally,
to detect clinical or occult stress urinary incontinence.
Further examination must consist of vaginal palpation of the pelvic floor and must
include an assessment of pelvic floor contractility as well as rectal examination
of patients with defecation disorders and fecal incontinence.
Quick urine tests (dipstick test) are not sufficiently sensitive for proper urine
analysis; women with dysuria and a negative urine dipstick test should be assessed
using a urine culture test with an antibiogram [8], [9].
2.3 Imaging
2.3.1 Sonography
For an in-depth discussion, please refer to the detailed AWMF guideline on the use
of ultrasonography in urogynecology (only available in German: Sonographie im Rahmen
der urogynäkologischen Diagnostik, 015-055).
Assessment of residual urine with ultrasonography is part of the standard examination
for prolapse and bladder voiding disorders.
Evidence-based recommendation 2.E1
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Level of evidence 3
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Grade of recommendation 0
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Renal sonography to exclude urinary retention is particularly recommended in patients
with high-grade prolapse. The prevalence of hydronephrosis is reported to be 5–17 %,
although this usually decreases following surgical treatment [52], [53], [54], [55].
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Evidence-based recommendation 2.E2
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Level of evidence 3
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Grade of recommendation 0
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Pelvic floor sonography can be a useful diagnostic tool in addition to vaginal and
rectal examination. Biological meshes are not detectable sonographically [10]. The position, mobility, folding and even tearing of the proximal anchor fixation
of synthetic meshes can be detected sonographically using a perineal, introital or
endovaginal approach [10], [11], [12], [13].
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Evidence-based recommendation 2.E3
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Level of evidence 3
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Grade of recommendation 0
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Perineal sonography can also be used as visual biofeedback to explain findings to
patients and show how pelvic floor contractions affect the bladder neck, e.g. prior
to coughing to reduce the prolapse [14], [15], [16].
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Evidence-based recommendation 2.E4
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Level of evidence 4
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Grade of recommendation 0
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Vaginal sonography can be used to shed light on a number of different aspects:
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For a depiction of the uterus and the adnexa prior to surgery
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To exclude uterine pathologies prior to carrying out uterus-preserving surgery
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To assess cervical length or the relationship between the uterine body and the cervix:
cervical elongation after uterus-preserving surgery can result in persisting symptoms.
-
To exclude extrauterine pelvic pathologies
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2.3.2 MRI
As with defecography, dynamic MRI can be used to obtain images of all three compartments
at rest, during pressing, and during contractions of the pelvic floor [17]. Dynamic MRI can be used to visualize complex and/or recurrent prolapse conditions
[18], [19] and is particularly suitable to assess internal rectal prolapse/intussusception
and rectal emptying or stool retention [20], [21], [22].
Evidence-based recommendation 2.E5
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Level of evidence 3
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Grade of recommendation 0
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Dynamic MRI can be useful to visualize complex conditions and symptoms.
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2.4 Urodynamic examination
Evidence-based recommendation 2.E6
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Level of evidence 3
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Grade of recommendation 0
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A systematic review of diagnostic tests showed that the patientʼs medical history
and a clinical stress test are good predictors of stress urinary incontinence in urodynamic
studies [23], [24]. There are no data which confirm the necessity of carrying out urodynamic studies
prior to planned prolapse surgery. Occult stress incontinence can also be detected
by carrying out stress test with a sufficiently full bladder after prolapse repositioning.
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2.5 Cystourethroscopy
Evidence-based recommendation 2.E7
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Level of evidence 4
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Grade of recommendation 0
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If diffuse symptoms and findings such as bladder pain and hematuria are also present,
particularly if the patient has had a previous operation, cystourethroscopy can help
to exclude morphological causes such as bladder tumors or stones, urethral stenosis,
intravesical mesh erosion, or chronic urothelial changes caused by interstitial cystitis
[25], [26], [27].
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Evidence-based recommendation 2.E8
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Level of evidence 3
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Grade of recommendation B
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Cystourethroscopy is recommended at the end of prolapse surgery to exclude intraoperative
bladder and urethral injury and to establish ureter function.
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3 Patient Information
To enable patients to make an informed decision, the information given to patients
should be well structured and should include, where possible, the physicianʼs own
data on the successes and complications of interventions. The discussion with the
patient should include information about the patientʼs medical condition; observant,
conservative and surgical treatment options along with their anatomical and functional
success rates; the advantages and disadvantages of mesh implants; complications and
their treatment options; the impact of therapy on the patientʼs sexuality, bladder
and bowel functions, and further surgical interventions which could potentially be
necessary (e.g. two-stage stress urinary incontinence surgery).
4 Conservative Therapy
As many women are not aware of their pelvic organ prolapse, surgery should only be
carried out in symptomatic patients and in patients who are bothered by the prolapse
[28]. Conservative options include pelvic floor rehabilitation, pessary therapy, clinical
observation, reduction of known risk factors such as obesity, smoking and chronic
constipation, digital support during defecation (pressure placed on the posterior
vaginal wall or the perineum).
Evidence-based recommendation 4.E1
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Level of evidence 3
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Grade of recommendation C
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As prolapse regression without therapy has also been reported [28], [29], observation alone should also be listed as an option during the discussion with
the patient.
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Evidence-based recommendation 4.E2
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Level of evidence 2
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Grade of recommendation B
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Systemic hormone replacement therapy is not beneficial for pelvic floor function and
should not be explicitly prescribed to treat prolapse or incontinence [30], [31].
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Evidence-based recommendation 4.E3
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Level of evidence 2
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Grade of recommendation B
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The application of topical estrogen in the vagina is an established treatment for
vaginal dryness and irritation of the vagina (e.g., to treat symptoms of atrophic
vaginitis) [32], [33] and is essential in pessary therapy to prevent local lesions, bleeding, and necrosis
[34], [35].
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4.1 Pelvic floor muscle training
Several randomized studies have shown that targeted pelvic floor muscle training can
reduce the symptoms of prolapse, lower the grade of prolapse, and prevent progression
[36], [37], [38], [39], [40], [41]. Studies have also demonstrated an improvement in associated stress urinary incontinence
following pelvic floor muscle training [37], [39], [42]. It should be noted, however, that in these studies the correct pelvic floor contraction
was determined by the physiotherapist by means of palpation. This was then followed
by individual and targeted training of the pelvic floor musculature, which should
not be equated with the unspecific pelvic floor exercises often done in Germany [43].
Five controlled randomized studies reported conflicting results in response to the
question whether perioperative pelvic floor muscle training could improve functional
outcome after prolapse and/or incontinence surgery [44], [45], [46], [47]: two of the studies [44], [46] reported improved incontinence and prolapse symptoms; however, three other studies
[45], [47], [48] found no difference in outcomes.
4.2 Pessary therapy
Pessaries can be successfully fitted in most women [49], with observational studies reporting success in around 50–100 % of cases; however,
successful continuation of pessary therapy is much lower, with a reported rate of
14–67 % [50], [51], [52], [53], [54], [55], [56], [57], [58], [59]. In addition to prolapse symptoms, stress incontinence has been reported to improve
in 23–45 % of cases; studies have also reported improvements for overactive bladder,
defecation disorders, sexual function and body image [52], [60], [61], [62], [63]. A prospective study found no significant differences in terms of symptom scores
between the functional results for pessary therapy and those for surgical therapy
[64].
Indications for pessary therapy can include patient preference for conservative treatment,
temporary family planning when the patient intends to have more children, and an increased
risk of perioperative complications due to co-morbidities [65].
Evidence-based recommendation 4.E4
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Level of evidence 1
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Grade of recommendation B
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Targeted pelvic floor muscle training (note: not gymnastical exercises) should at
least be offered to patients who have lower stages of prolapse (Stages I and II) to
reduce prolapse symptoms and concomitant stress urinary incontinence.
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Evidence-based recommendation 4.E5
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Level of evidence 3
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Grade of recommendation 0
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Accompanying perioperative pelvic floor rehabilitation may be considered; however,
the results reported in studies differ considerably.
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Evidence-based recommendation 4.E6
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Level of evidence 2
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Grade of recommendation B
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Pessary therapy is a good conservative option which should be offered to patients.
It is still not clear which pessary is most suitable for which type of prolapse.
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4.3 Recommendations for conservative therapy
5 Surgical Therapy of Anterior Compartment Prolapse
5.1 Anterior colporrhapy or anterior vaginal wall repair
Evidence-based recommendation 5.E1
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Level of evidence 3
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Grade of recommendation B
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Simultaneous apical fixation appears to significantly reduce the risk of recurrence.
The patient should be examined to determine whether concomitant anterior and middle
compartment prolapse is present, as anterior vaginal wall repair could be performed
concomitantly with apical fixation.
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Evidence-based recommendation 5.E2
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Level of evidence 3
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Grade of recommendation 0
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The risk of cystocele recurrence appears to be higher following anterior vaginal wall
repair in patients with levator defects (avulsions). Anterior mesh placement can be
considered in these patients [74].
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Prolapse of the anterior vaginal wall is commonly associated with an apical defect,
so that surgical repair of the middle compartment should be considered in these patients
[66].
Success rates for anterior vaginal wall repair were reported in 22 randomized studies;
they varied strongly and also depended on the additional surgical procedures carried
out concomitantly. Because of the different surgical techniques used in the studies,
the calculated cumulative success rate of 63 % for more than 1000 women who underwent
surgery should be interpreted with caution.
If surgery is performed concomitantly to support the apical (middle) compartment,
the risk of recurrence decreases significantly (OR: 0.68; 95 % CI: 0.54–0.85).
The risk of recurrence appears to increase almost twofold in patients with levator
defects (avulsion of the pubococcygeus muscle from the pubic rami) [67], [68], [69], [70].
5.2 Surgery using synthetic or biological implants
Evidence-based recommendation 5.E3
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Level of evidence 1a
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Grade of recommendation A
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The use of synthetic meshes in the anterior compartment further reduces the anatomical
and subjective risk of prolapse recurrence but has no positive impact on patientsʼ
quality-of-life. However, de novo dyspareunia and re-operation for mesh complications
and urinary stress incontinence are more common compared to anterior vaginal wall
repair. The decision making process has to include information on rates of re-operation,
chronic pain syndrome and dyspareunia.
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Evidence-based recommendation 5.E4
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Level of evidence 3
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Grade of recommendation 0
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When placing a synthetic mesh in the anterior compartment, concomitant apical mesh
fixation or surgery to stabilize the middle compartment can be considered.
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Evidence-based recommendation 5.E5
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Level of evidence 1b
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Grade of recommendation B
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Because the success rates for biological implants are not higher than the success
rates for anterior vaginal wall repair, biological implants should not be used.
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Evidence-based recommendation 5.E6
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Level of evidence 3
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Grade of recommendation 0
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Women with levator defects (avulsion of the pubococcygeus muscle from the lower pubic
rami) generally appear to have an increased risk of recurrence, although the risk
is lower following anterior synthetic mesh augmentation. Anterior synthetic mesh augmentation
can or may therefore be considered in these patients.
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In studies with apical fixation or concomitant apical surgery [71], [72], [73], [74], [75], [76], [77], [78], [79], anterior repair using a synthetic mesh (excluding Prolift® and Perigee®) had a
cumulative success rate of 93 %; the cumulative success rate of studies without apical
fixation or without standard apical surgery [80], [81], [82], [83], [84], [85], [86], [87], [88], [89] was 83 %. The cumulative rate of mesh erosion was 8 % (137/1740); the cumulative
rate for chronic pain and de novo dyspareunia was 7 % (59/846).
In a retrospective analysis, women with levator avulsion had a higher risk of cystocele
recurrence even after placement of a synthetic mesh [90].
A meta-analysis of randomized studies showed that the risk of recurrence increased
threefold when no synthetic mesh was placed (RR: 3.5; 95 % CI: 2.7–4.4). The success
rate for anterior repair was 52 %, which increased to 86 % (p < 0.001) with mesh augmentation.
Overall, repeat surgery for mesh complications, stress urinary incontinence or recurrent
prolapse was more common following synthetic mesh implantation (RR: 0.58; 95 % CI:
0.42–0.81). Anterior repair reduced the risk of a repeat operation. After anterior
repair, the risk of de novo dyspareunia, which occurs more frequently after transobturator
synthetic mesh placement, was also lower (RR: 0.46; 95 % CI: 0.22–0.96). But this
was not reflected in the validated sexual questionnaires (PISQ) which were used in
some studies.
Meta-analysis of randomized studies showed that Pelvicol® augmentation did not offer
better results than anterior repair (RR: 1.3; 95 % CI: 0.8–2.2). Only one RCT [91] reported superior results following Pelvicol® augmentation. This did not change,
even when the results of all studies which used any type of biological implant were
combined; the use of biological graft material did not appear to improve success rates
(RR: 1.34; 95 % CI: 0.97–1.86).
5.3 Vaginal, abdominal or laparoscopic repair of paravaginal defects
Because studies differed considerably and the concomitant procedures, which mainly
affected the middle compartment and often included apical fixation, also varied significantly,
the reported success rates of between 70 and 100 % (vaginal repair: between 90 and 100 %, cumulative success rate: 91 % [92], [93], [94], [95], [96], [97]; abdominal repair: between 70 and 95 %, cumulative success rate: 94 % [92], [98], [99], [100], [101], [102]; laparoscopic repair: only one study, success rate: 80 % [103]) should be interpreted with caution.
5.4 Recommendations for the anterior compartment
Evidence-based recommendation 5.E7
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Level of evidence 3
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Grade of recommendation B
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If anterior vaginal wall repair is carried out, concomitant apical fixation appears
to significantly decrease the risk of recurrence. Patients should therefore be examined
carefully to determine whether they may have both anterior and middle compartment
prolapse which would then allow anterior vaginal wall repair to be combined with apical
fixation.
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Evidence-based recommendation 5.E8
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Level of evidence 3
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Grade of recommendation 0
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The presence of a levator defect (avulsion) appears to increase the risk of cystocele
recurrence following anterior vaginal wall repair, and anterior mesh placement can
be considered in these patients [70].
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Evidence-based recommendation 5.E9
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Level of evidence 1a
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Grade of recommendation A
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The use of synthetic mesh in the anterior compartment reduces the anatomical and subjective
rates of prolapse recurrence but without having an additional impact on patientsʼ
quality of life. However, rates of de novo dyspareunia and repeat surgery for mesh
complications and stress urinary incontinence are higher compared to rates for anterior
vaginal wall repair, indicating that discussions with the patient must include information
about repeat surgery, chronic pain syndrome, and dyspareunia.
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Evidence-based recommendation 5.E10
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Level of evidence 3
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Grade of recommendation 0
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When placing a synthetic mesh in the anterior compartment it is worth considering
concomitant apical mesh fixation or surgery to stabilize the middle compartment.
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Evidence-based recommendation 5.E11
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Level of evidence 1b
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Grade of recommendation B
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Because the success rates for biological implants are not higher compared to the rates
for anterior vaginal wall repair, biological implants are not necessary.
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Evidence-based recommendation 5.E12
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Level of evidence 3
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Grade of recommendation 0
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Women with levator defects (avulsion of the pubococcygeus muscle from the pubic rami)
generally appear to have a higher risk of recurrence, although the risk is lower after
anterior synthetic mesh augmentation, which is why this approach should be considered
for these patients.
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Evidence-based recommendation 5.E13
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Level of evidence 3
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Grade of recommendation 0
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A lack of adequate studies makes it impossible to give a clear recommendation in support
of paravaginal defect repair, irrespective of whether it is carried out vaginally,
abdominally or laparoscopically. This is because apical procedures are usually carried
out concomitantly and contribute to high success rates.
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6 Surgical Therapy of Posterior Compartment Prolapse
Rectoceles and posterior enteroceles can be the cause of both prolapse symptoms and
defecation disorders. Defecation disorders often require manual transvaginal, transanal
or perineal assistance. It is important to determine preoperatively whether these
disorders are caused by a rectocele, an intussusception or by descending perineum
syndrome. Interdisciplinary collaboration with coloproctologists can be useful, particularly
if a defecation disorder is present without a visible rectocele.
6.1 Posterior colporrhapy or posterior vaginal wall repair
The cumulative success rate for posterior vaginal wall repair using midline suturing of vaginal connective tissue
(fascia) is significantly higher at 86 % (cumulative success rate: 83/576) than the 70 % reported
for defect-specific repair (cumulative success rate: 82/271). The risk of recurrence is significantly reduced
if midline fascial suturing is done (OR: 0.4; 95 % CI: 0.28–0.56), which is why this
technique should be the method of choice for primary rectocele repair.
The standard approach used to consist of the plication of the levator ani, particularly
of the distal levator, but this technique did not reduce the rate of recurrence (45/220,
cumulative success rate 80 %). Instead, use of an isolated midline fascial suture
has been found to yield better results (OR: 0.65; 95 % CI: 0.44–0.98) [104], [105], [106]. Approximation of the levator ani is not considered necessary for posterior vaginal
wall repair, as the success rates with this method are not higher than those obtained
using a midline fascial suture, and high rates of dyspareunia have been reported with
this technique.
Two randomized studies reported that transvaginal posterior vaginal wall repair was
superior to transanal rectocele repair in terms of anatomical and functional success
rates [104], [107]. Transvaginal posterior vaginal wall repair is the method of choice to treat symptomatic
rectocele and should be used in preference to transanal rectocele repair.
6.2 Surgery using synthetic or biological implants
The use of biological implants in the posterior compartment did not show any benefits compared to posterior vaginal wall repair. On the contrary,
posterior vaginal wall repair was found to be superior to the augmentation procedure
with grafts, and meta-analysis of all comparative randomized and non-randomized studies
showed that posterior vaginal wall repair halved the risk of recurrence (RR: 0.58;
95 % CI: 0.41–0.84). The use of xenografts (biological implants) in the posterior
compartment should be avoided because their use offers no benefits.
There are no randomized studies on the use of non-absorbable synthetic mesh in the posterior compartment. Although non-controlled prospective and retrospective studies reported a lower rate
of recurrence when synthetic mesh was used, there are currently no comparative studies.
There is therefore no reason to use synthetic meshes routinely for primary vaginal wall repair of the posterior compartment.
6.3 Recommendations for the posterior compartment
Evidence-based recommendation 6.E1
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Level of evidence 1
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Grade of recommendation A
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Posterior vaginal wall repair to treat a symptomatic rectocele should be chosen in
preference to transanal rectocele repair.
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Evidence-based recommendation 6.E2
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Level of evidence 2
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Grade of recommendation B
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Posterior vaginal wall repair using midline fascial suturing resulted in higher rates
of success compared to defect-specific fascial repair and this method should be preferred
for primary rectocele repair.
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Evidence-based recommendation 6.E3
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Level of evidence 3
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Grade of recommendation 0
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Plication of the levator ani is not necessary for posterior vaginal wall repair as
it does not result in higher success rates compared to a midline fascial repair and
the procedure is associated with high rates of dyspareunia.
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Evidence-based recommendation 6.E4
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Level of evidence 1b
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Grade of recommendation A
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Xenografts (biological implants) should not be used for prolapse repair in the posterior
compartment because their use offers no benefits.
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Evidence-based recommendation 6.E5
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Level of evidence 3
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Grade of recommendation 0
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There are no randomized studies on the use of non-absorbable mesh in the posterior
compartment. Although non-controlled prospective and retrospective studies showed
that synthetic mesh placement was associated with a lower rate of recurrence, there
are no comparative studies on this issue. There is therefore currently no reason to
use synthetic meshes routinely for primary repair of the posterior compartment.
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7 Surgical Therapy of Middle Compartment Prolapse
The surgical repair of suspension defects in the middle compartment (level 1 according
to DeLancey [108]) is of special importance as this repair is often carried out in addition to repair
of the anterior or posterior compartment and is also as a stand-alone procedure to
treat uterine or vaginal vault prolapse.
7.1 Uterosacral ligament fixation/McCall technique/Shull technique
A systematic review of transvaginal high fixation of the vaginal vault to the uterosacral
ligaments showed a cumulative apical success rate of 98 % (95 % CI: 95.7–100), an
anterior success rate of 81 % (95 % CI: 67.5–94.9) and a posterior success rate of
87 % (95 % CI: 80–94.9) [109]. Retrospective studies of laparoscopic fixation of the vaginal vault to the uterosacral
ligaments after concomitant hysterectomy reported an apical failure rate of 11–13 %
[110], [111].
Vaginal suspension using the uterosacral ligaments is associated with the risk of
ureteral injury, ureter ligation and ureteral medial deviation in around 6 % (1–11 %),
and intraoperative cystoscopy is therefore recommended.
7.2 Sacrospinous fixation
In a randomized study published in 2014, Barber et al. [48] reported no significant anatomical or functional differences between vaginal fixation
to the uterosacral ligaments or sacrospinous fixation.
Recurrence is most common in the anterior compartment, with reported rates of 5–39 %
(157/1036, 15 %), and occurs less often in the posterior compartment (5–12 %, 32/442,
7 %). Apical fixation is very effective with a cumulative success rate of 96 % (rate
of recurrence: 0–14 %, 45/1121 [4 %]).
7.3 Abdominal, laparoscopic and robot-assisted sacrocolpopexy
A systematic review by Nygaard et al. [112] reported apical success rates of 78–100 % for abdominal sacrocolpopexy and a cumulative
rate of re-operation for prolapse recurrence of 4.4 %. In 23 studies, laparoscopic sacrocolpopexy had an equally high cumulative success rate of 91 % (number of failures: 215/2341).
In a randomized study, Maher et al. compared laparoscopic sacrocolpopexy including
anterior and posterior polypropylene mesh extension with the vaginal Prolift® mesh
kit which has since been withdrawn from the market by its manufacturer (Ethicon®)
and is no longer available [113]. While laparoscopic sacrocolpopexy took longer (difference: + 52 min [95 % CI: 41.5–62.6]),
patients were discharged earlier from hospital and were able to resume day-to-day
activities more quickly. After two years, recurrence across all compartments was significantly
more common in the vaginal mesh group (57 vs. 23 %) [113], as was the rate of re-operations (22 vs. 5 %, p = 0.006).
7.4 Vaginal high levator myorrhaphy and vaginal fixation of the vaginal vault to the
Iliococcygeus fascia
In a randomized study, the apical success rate was 97 % after levator myorrhaphy and
98 % following uterosacral ligament fixation. The rate of cystocele recurrence was
relatively high at 29 and 35 %, respectively [114]. There are only a few case series describing vaginal fixation to the fascia of the
iliococcygeus muscle, with apical success rates of 53, 83 and 96 %.
7.5 Uterus-preserving procedures
If the uterus is healthy with no history of previous disease and no signs of clinical
or sonographic uterine pathology, if the patient wishes it, she should be offered
a uterus-preserving procedure. Options include vaginal sacrospinous hysteropexy, laparoscopic
or open sacrohysteropexy with mesh interposition, and fixation of the uterus to the
uterosacral ligaments. Please also refer to the AWMF hysterectomy guideline (015-070).
Five studies directly compared vaginal hysterectomy with vaginal vault fixation to
the uterosacral ligaments and sacrospinous hysteropexy but found no significant differences
(rates of recurrence: 8 vs. 4 %).
7.6 Colpocleisis
Colpocleisis is considered a relatively quick procedure with few complications and
is predominantly offered to older women with multiple morbidities who are no longer
sexually active and no longer wish to be sexually active. Recurrence following colpocleisis
is very rare; studies report an improvement in quality of life and in bladder and
bowel function but also that a small number of women (< 5 %) regretted the operation
[115], [116]. Crisp et al. [117] reported in 2013 that 13.8 % of 87 women regretted the procedure.
7.7 Recommendations for the middle compartment
Evidence-based recommendation 7.E1
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Level of evidence 2
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Grade of recommendation A
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There is good evidence showing that sacrospinous colpopexy, vaginal or laparoscopic
fixation to the uterosacral ligaments and open, laparoscopic or robot-assisted sacrocolpopexy
can all be used for the repair of middle compartment prolapse, with success rates
of more than 90 % reported in the literature. The final choice of procedure must be
made together with the patient and must weigh up all the findings and symptoms, comorbidities,
risk factors, the potential benefit of a planned concomitant hysterectomy procedure,
the patientʼs own wishes, and the departmentʼs level of expertise.
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Evidence-based recommendation 7.E2
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Level of evidence 2
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Grade of recommendation B
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Abdominal sacrocolpopexy is a procedure which has been studied very extensively and
for the longest period of time; it is currently the most effective procedure. Laparoscopic
sacrocolpopexy can also be considered by departments with the necessary experience
in carrying out the procedure.
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Evidence-based recommendation 7.E3
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Level of evidence 2
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Grade of recommendation B
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Carrying out a hysterectomy concomitantly with sacrocolpopexy should be avoided because
of the increased risk of mesh erosion.
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Evidence-based recommendation 7.E4
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Level of evidence 1b
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Grade of recommendation B
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Sacrocolpopexy and sacrospinous fixation procedures are approximately equivalent but
offer different benefits and have different disadvantages. If there are no contraindications,
sacrocolpopexy can be carried out in preference to sacrospinous fixation.
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Evidence-based recommendation 7.E5
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Level of evidence 2
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Grade of recommendation A
|
The use of absorbable or biological implants for fixation to the sacrum in sacrocolpopexy
is not recommended.
|
Evidence-based recommendation 7.E6
|
Level of evidence 2
|
Grade of recommendation B
|
Intraoperative cystoscopy is recommended for vaginal vault suspension to the uterosacral
ligaments because of the increased risk of injury to the ureter.
|
Evidence-based recommendation 7.E7
|
Level of evidence 2
|
Grade of recommendation B
|
Uterine preservation should be considered in patients with the appropriate indications.
Vaginal sacrospinous hysteropexy is a good option; there is not yet enough long-term
data available on sacrohysteropexy procedures with mesh interposition or fixation
to the uterosacral ligaments.
|
Evidence-based recommendation 7.E8
|
Level of evidence 3
|
Grade of recommendation 0
|
Vaginal high levator myorrhaphy and vaginal fixation of the vaginal vault to the fascia
of the iliococcygeus muscle have not been studied much and should therefore only be
carried out if specifically indicated or if there are no other alternatives.
|
Evidence-based recommendation 7.E9
|
Level of evidence 3
|
Grade of recommendation 0
|
Colpocleisis can be considered in selected patients after carefully discussing the
procedure with patients.
|
8 Genital prolapse and stress urinary incontinence
A risk calculator to weigh up the risk of postoperative stress incontinence was developed
based on several models and studies [118]. The risk calculator takes a number of factors into account (www.r-calc.com/ExistingFormulas.aspx?filter=CCQHS).
8.1 Continent women with genital prolapse
A meta-analysis showed that, compared to transobturator mesh procedures, anterior
vaginal wall repair protected patients from developing stress incontinence (RR: 0.64;
95 % CI: 0.42–0.97) [119]. However, one study evaluated the long-term data after three years and no longer
found any significant difference between the two procedures [72], [120].
The CARE study [121] compared abdominal sacrocolpopexy in preoperatively continent women with (n = 157)
and without (n = 165) concomitant Burch colposuspension. At two years postoperatively,
significantly fewer women in the Burch group were incontinent. The study was therefore
terminated ahead of schedule and is underpowered.
8.2 Women with symptomatic stress urinary incontinence and genital prolapse
The results of two randomized studies of women with stress incontinence and cystocele
who underwent anterior vaginal wall repair showed that 48 % (19/40) were continent
postoperatively [122], [123]. The cumulative continence rate following transobturator mesh was 61 % (81/132)
[124], [125], [126]. However, after the additional insertion of a suburethral tape, 235 out of 237 women
(99 %) were continent postoperatively [87], [127], [128], [129].
One randomized study investigated the question whether treatment should be carried
out as a one-stage or a two-stage procedure; it was found that the treatment of stress
incontinence was equally successful, irrespective of whether the suburethral TVT was
inserted at the same time as the anterior vaginal wall repair (83/87, 95 %) or three
months later (47/53, 89 %; based on an on-treatment analysis) [130]. However, 27/94 women (29 %) were continent following prolapse surgery alone and
refused the planned TVT procedure three months later [130].
8.3 Women with occult stress incontinence and genital prolapse
Three randomized studies reported that suburethral tape insertion concomitantly with
prolapse repair (especially anterior vaginal wall repair) significantly reduced stress
incontinence rates (21/116, 18 % vs. 64/125, 51 %) [131], [132], [133]. A meta-analysis of these studies showed a decrease by almost 50 % (RR: 0.54; 95 %
CI: 0.41–0.72).
8.4 Recommendations for prolapse and urinary stress incontinence
Evidence-based recommendation 8.E1
|
Level of evidence 2
|
Grade of recommendation B
|
In preoperatively continent women with genital prolapse, anterior vaginal wall repair
is preferable to transobturator mesh placement to reduce the rate of de novo stress
incontinence. The higher rate of recurrence associated with anterior vaginal wall
repair compared to transobturator mesh placement should be take into consideration
when discussing potential procedures with the patient.
|
Evidence-based recommendation 8.E2
|
Level of evidence 2
|
Grade of recommendation B
|
A concomitant Burch colposuspension can be additionally offered to patients undergoing
sacrocolpopexy as a prophylactic measure against postoperative stress incontinence.
|
Evidence-based recommendation 8.E3
|
Level of evidence 1 a
|
Grade of recommendation A
|
Patients with occult stress incontinence should be informed about the possibility
of undergoing concomitant suburethral tape insertion during vaginal prolapse surgery.
|
Evidence-based recommendation 8.E4
|
Level of evidence 2
|
Grade of recommendation A
|
Suburethral tape insertion can also be performed as a two-stage procedure, e.g. at
three months after prolapse surgery.
|
Evidence-based recommendation 8.E5
|
Level of evidence 2
|
Grade of recommendation B
|
Women with symptomatic stress incontinence and prolapse can be offered simultaneous
surgery to treat stress incontinence.
|
Evidence-based recommendation 8.E6
|
Level of evidence 2
|
Grade of recommendation 0
|
Suburethral tape insertion can be carried out in preference to Burch colposuspension
when treating patients with sacrocolpopexy.
|
9 Perioperative Management
There is very little evidence-based literature on the perioperative management of
gynecological or urogynecological patients. Please refer to the appropriate AWMF guidelines
for the perioperative administration of antibiotics, thrombosis prophylaxis and patient
positioning (029-022, 003-001, 015-077).
Evidence-based recommendation 9.E1
|
Level of evidence 2
|
Grade of recommendation 0
|
Preoperative and/or postoperative pelvic floor muscle training may be prescribed;
however, there is no clear evidence that this will improve incontinence and prolapse
compared to pelvic floor surgery without perioperative pelvic floor muscle training.
|
Evidence-based recommendation 9.E2
|
Level of evidence 2
|
Grade of recommendation B
|
The preoperative placement of ureteral stents can be dispensed with as it does not
reduce ureteral injuries.
|
Evidence-based recommendation 9.E3
|
Level of evidence 3
|
Grade of recommendation 0
|
Postoperative application of topical estrogen can improve vaginal flora and reduce
granulation tissue; there is no evidence that it reduces the rates of mesh erosion.
|
10 Complications and Their Treatment
10.1 Mesh erosion, extrusion, shrinkage
The rates of vaginal erosion following abdominal sacrocolpopexy are between 0 and
10 % after 7 years [134]. The reported rates following vaginal mesh implantation were between 0 and 30 %
[135], [136]; in the analysis carried out for this guideline the calculated rate was 8 % (137/1740).
Risk factors for erosion were concomitant hysterectomy procedure, smoking, and the
use of polytetrafluoroethylene mesh [134] as well as higher BMI > 30 kg/m2 (OR: 10) [137]. The colpotomy required for mesh placement should be as short as possible [138]. Smoking increases the risk of vaginal mesh erosion in both vaginal and abdominal
mesh implantations (OR: 4.2; 95 % CI: 2.5–7.0) [139], [140], [141], [142].
Treatment depends on the extent of erosion and the presence or absence of co-infections.
Topical application of estrogen is recommended but is often not enough, and partial
excision of the mesh is then necessary [143]. The cumulative success rate for topical estrogen application to treat vaginal erosion
is 24 % (33/139) [142], [144], [145], [146], [147], [148], [149].
10.2 Organ injuries
There are few reports in the literature on injuries to the bladder, urethra and ureter.
Late visceral mesh erosion is rare, and the only literature to date consists of individual
case reports.
Mesh implantation is still possible after intraoperative bladder injury and repair
immediately intraoperatively. However, placement of a synthetic mesh should be avoided
if there is inadvertent rectotomy intraoperatively.
10.3 Sexual dysfunction
Prolapse surgery can improve dyspareunia but it can also be the cause of dyspareunia
arising from scarring, overcorrection, hematoma formation, or nerve irritation or
injury. Chronic pain and dyspareunia have been reported in 3–13 % of cases, particularly
after vaginal mesh placement [135], [136]. If the cause of discomfort is found to be “tension” of the mesh or its fixation
arms, treatment options include mobilization of the mesh, incision of the mesh or
of its fixation arms, and excision of part of the mesh [144], [150]. Complete excision of the mesh is rarely indicated. Surgical procedures to partially
or completely excise the mesh can be difficult; surgery may not always eliminate or
reduce patient discomfort and can lead to further complications [150], [151], [152]. This is a particular problem of mesh-assisted surgical procedures, and it is therefore
particularly important to provide the patient with detailed information on the risks
involved.
Evidence-based recommendation 10.E1
|
Level of evidence 3
|
Grade of recommendation B
|
During the discussion with their physician, patients who smoke should be informed
about the increased risk of mesh erosion after planned mesh implantation, and the
physician should recommend that the patient stops smoking.
|
Evidence-based recommendation 10.E2
|
Level of evidence 3
|
Grade of recommendation B
|
Initial treatment of vaginal mesh erosion can consist of the application of topical
estriol or estradiol. If the patient does not respond to treatment, local excision
of the exposed mesh should be performed using tension-free vaginal suturing.
|
Evidence-based recommendation 10.E3
|
Level of evidence 3
|
Grade of recommendation B
|
Complete excision of the mesh, particularly of multifilament mesh, should be aimed
for in patients with chronic mesh infection or recurrent abscess.
|
Evidence-based recommendation 10.E4
|
Level of evidence 3
|
Grade of recommendation B
|
Because of the high number of associated complications, multifilament mesh should
not be used for prolapse repair.
|
Evidence-based recommendation 10.E5
|
Level of evidence 3
|
Grade of recommendation 0
|
If the mesh arms or the synthetic mesh are identified as the cause of chronic pain
syndrome, partial or complete mesh excision or division of fixation arms from the
central graft can be considered.
|
Evidence-based recommendation 10.E6
|
Level of evidence 4
|
Grade of recommendation 0
|
Planned mesh placement is still possible despite inadvertent injury to the bladder
if the bladder is treated immediately intraoperatively; however, mesh placement should
be avoided after inadvertent injury to the rectum.
|
10.4 Recommendations for the management of complications
11 Summary
An in-depth discussion with the patient about expectant, conservative and surgical
management options to treat prolapse is necessary. Conservative options include targeted
pelvic floor muscle training for patients with low grade prolapse, as this can reduce
the extent of prolapse and incontinence symptoms, and pessary therapy. A pessary can
usually be successfully fitted in most patients and is a low-risk option.
The individual surgical procedure should be chosen in a shared decision making process
together with the patient. Current studies and evidence show that there is a wide
range of surgical procedures which involve either autologous tissue or synthetic mesh
augmentation. Because of the higher rate of complications after vaginal mesh implants,
this should only be used when specifically indicated, after the patient has been informed
in detail and the benefits and disadvantages carefully weighed up. At present, it
is not possible to clearly define the indications. Possible indications include recurrent
or total prolapse combined with risk factors such as obesity, chronic obstructive
pulmonary disease and indications of generalized connective tissue weakness. Patients
with levator defects (levator avulsions) have a higher risk of anterior compartment
prolapse recurrence, and placement of a synthetic mesh appears to reduce this risk.
Mesh placement should be considered for patients with high grade prolapse, prolapse
recurrence, levator avulsions and for patients who are anxious about anatomical correction.
The patient must be informed in detail about the success rates of individual procedures
with and without mesh placement, about the treatment alternatives and possible complications.
The patient should be informed about the lack of studies on long-term outcomes after
vaginal mesh placement.
Regular postoperative documentation of pelvic floor dysfunction and of patientsʼ quality
of life is recommended to evaluate the surgical technique and the indications and
adapt them where necessary. New surgical procedures with or without implants should
only be introduced in the context of clinical trials. In addition to anatomical outcomes,
studies should particularly focus on the prospective evaluation of pelvic floor function
and on patientsʼ quality of life.
Guideline Program
Editors
Leading Professional Medical Associations
German Society of Gynecology and Obstetrics (Deutsche Gesellschaft für Gynäkologie
und Geburtshilfe e. V. [DGGG])
Head Office of DGGG and Professional Societies
Hausvogteiplatz 12
DE-10117 Berlin
info@dggg.de
http://www.dggg.de/
President of DGGG
Prof. Dr. Birgit Seelbach-Göbel
Universität Regensburg
Klinik für Geburtshilfe und Frauenheilkunde
St. Hedwig-Krankenhaus Barmherzige Brüder
Steinmetzstraße 1–3
DE-93049 Regensburg
DGGG Guidelines Representative
Prof. Dr. med. Matthias W. Beckmann
Universitätsklinikum Erlangen
Frauenklinik
Universitätsstraße 21–23
DE-91054 Erlangen
Guidelines Coordination
Dr. med. Paul Gaß, Tobias Brodkorb, Marion Gebhardt
Universitätsklinikum Erlangen
Frauenklinik
Universitätsstraße 21–23
DE-91054 Erlangen
fk-dggg-leitlinien@uk-erlangen.de
http://www.dggg.de/leitlinienstellungnahmen
Austrian Society of Gynecology and Obstetrics (Österreichische Gesellschaft für Gynäkologie
und Geburtshilfe [OEGGG])
Innrain 66A
AT-6020 Innsbruck
stephanie.leutgeb@oeggg.at
http://www.oeggg.at
President of OEGGG
Prof. Dr. med. Petra Kohlberger
Universitätsklinik für Frauenheilkunde Wien
Währinger Gürtel 18–20
AT-1180 Wien
OEGGG Guidelines Representative
Prof. Dr. med. Karl Tamussino
Universitätsklinik für Frauenheilkunde und Geburtshilfe Graz
Auenbruggerplatz 14
AT-8036 Graz
Swiss Society of Gynecology and Obstetrics (Schweizerische Gesellschaft für Gynäkologie
und Geburtshilfe [SGGG])
Gynécologie Suisse SGGG
Altenbergstraße 29
Postfach 6
CH-3000 Bern 8
sekretariat@sggg.ch
http://www.sggg.ch/
President of SGGG
Dr. med. David Ehm
FMH für Geburtshilfe und Gynäkologie
Nägeligasse 13
CH-3011 Bern
SGGG Guidelines Representative
Prof. Dr. med. Daniel Surbek
Universitätsklinik für Frauenheilkunde
Geburtshilfe und feto-maternale Medizin
Inselspital Bern
Effingerstraße 102
CH-3010 Bern