Keywords pelvic organ prolapse - pelvic floor disorders - reconstructive surgical procedures
- patient health questionnaire - patient-reported outcome measures
Palavras-chave prolapso de órgão pélvico - distúrbios do assoalho pélvico - procedimentos cirúrgicos
reconstrutivos - questionário de saúde da paciente - medidas de resultados relatadas
pela paciente
Introduction
In high-income countries, individuals are growing ever older, and the need for pelvic
organ prolapse (POP) treatment is anticipated to increase in the coming decades.[1 ] The treatment of the apical compartment is critical to the successful repair of
severe POP. The two most commonly used techniques for apical corrections, through
vaginal procedures, are uterosacral ligament suspension (USLS) or sacrospinous ligament
fixation (SSLF).[2 ]
[3 ]
[4 ] Close to the ischial spines, USLS is an effective intraperitoneal procedure to restore
apical support in 98% of women.[5 ] The second technique is a widely used extraperitoneal procedure with subjective
cure rates ranging from 70% to 98%, and objective cure rates ranging from 67% to 97%.[6 ]
In an attempt to improve the anatomical result of pelvic reconstruction surgeries
with native tissues, the use of meshes was propagated with the intention of replacing
the injured native tissues, but numerous complications and high rates of reoperations
due to exposure, pain, and dyspareunia have been observed.[2 ]
[3 ]
[4 ]
[7 ] Because of warnings about the adverse effects of surgical correction with polypropylene
meshes,[7 ] efforts to identify the ideal technique to correct the apical effect by the vaginal
access have been undertaken.[7 ]
Thus, medical societies specializing in such fields have recommended that meshes be
used sparingly, with restrictions or not at all. It is possible that researchers in
countries such as the United States, Australia, and the United Kingdom have stopped
their studies on this topic because of mesh scrutiny.[1 ]
[7 ] Therefore, the objective of the present study was to compare the success rates and
outcomes of USLS and SSLF in the surgical treatment of advanced apical POP (stages
III and IV) under the subjective (Ba, Bp and C < −1) and anatomical (Ba, Bp and C
≤ 0) cure criteria of the Pelvic Organ Prolapse Quantification (POP-Q) System.[8 ]
Materials and Methods
The present prospective and randomized trial was performed at Universidade Federal
de São Paulo, Brazil, and it was approved by the Research Ethics Committee of said
institution (under CAAE 0833/06; CEP 0833/06 [attached document]) and registered on
Clinicaltrials.gov (NCT 01347021). The inclusion criteria were patients with apical
POP in stages III or IV, aged between 50 and 90 years, who voluntarily agreed to participate
and signed the informed consent form. The exclusion criteria were clinico-surgical
contraindications (severe comorbidities), apical POP in stages I and II; previous
pelvic radiotherapy or thromboembolic disorders; hormone therapy; endometrial hyperplasia
or high-grade squamous intraepithelial lesions of the cervix, vagina, or vulva, or
untreated genitourinary infection.
Standard history-taking was performed, as well as a physical examination in the supine
and standing positions to stage the POP through the POP-Q according to the recommendations
of the International Continence Society (ICS),[8 ]
[9 ] followed by reduction of the prolapse using gauze and a Cheron dressing forceps.
The stress test was performed with and without the prolapse reduction to diagnose
occult stress urinary incontinence (SUI). If involuntary leakage of urine was observed,
a urodynamic study was performed to include the correction of the SUI during the surgical
approach. All clinical evaluations were performed by the authors SBM and CCT through
sequential randomization (performed by LMO and MMD) and allocation of the sample into
two groups. The double-blinded randomization criterion was not applied because the
procedures would have had to be explained to the patient and performed by the authors
(SBM, CCT, LMO and MMD) in a technically-feasible manner with the scientific rigor
of sequential randomization. However, the statistician and the preoperative evaluator
were blinded because they did not know to which group the patient would be assigned.
The random allocation was sequential and performed 1:1 by drawing lots to avoid possible
selection biases, and, in the postoperative evaluation, there was no blinding. The
authors state that this does not compromise the outcomes, since the postoperative
evaluator was blinded to the other randomization processes. The initial sample consisted
of 58 patients with stage III and IV apical POP (according to the POP-Q). Of these,
7 were excluded (leaving 51 randomized patients) ([Fig. 1 ]) because they presented stage II apical prolapse. Vaginal hysterectomy (VH) was
performed in all patients, and correction of SUI with a retropubic midurethral sling
when indicated, followed by cystoscopy to assess ureteral integrity and correction
of site-specific apical defects through USLS or SSLF. Nine SUI corrections were performed
in the USLS group and seven in the SSLF group. All patients underwent posterior colporrhaphy
and perineorrhaphy, without the need for a description of the technique, as this was
not the technique under comparison in the study hypothesis. The analyses were performed
using the intention-to-treat (ITT) principle. In the USLS group, the uterosacral ligaments
were identified, seized with an Allis forceps ∼ 1 cm medial and posterior to the ischial
spine, and repaired, followed by a procedure to correct site-specific defects (in
the anterior compartment). After that, the sutures of the uterosacral ligament were
passed in the vaginal apex followed by anterior, posterior and perineorrhaphy or colporrhaphy.[10 ]
[11 ] In the SSFL group, correction of site-specific defects (in the anterior compartment)
was performed by means of a longitudinal incision of the posterior vaginal wall up
to 2 cm from the vaginal apex. Correction of the site-specific defects of the posterior
vaginal wall and enterocele was performed, and the knots of polypropylene threads
(number 0) were tied, leading the vaginal apex toward the sacrospinous ligament, avoiding
excessive traction.[10 ]
[11 ] All patients received intravenous antibiotic therapy (cephalothin and metronidazole)
intraoperatively. Meshes were not used to correct pelvic floor defects. Hospital discharge
occurred at least 48 hours after surgery, provided the patients were clinically well.
Fig. 1 Flow diagram of the present study.
Quality of life was assessed preoperatively, 6, and 12 months after the intervention
through the version validated for the Portuguese language of the Prolapse Quality
of Life (P-QoL) questionnaire,[12 ] which determined the criterion of subjective cure. This questionnaire contains 20
questions in 9 domains: general health perception; prolapse impact; role limitations;
physical limitations; social limitations; personal relationships; emotions; sleep/energy;
and severity measures.[12 ]
Anatomical success was evaluated by the positions of the vaginal apex, anterior and
posterior compartments after 6 and 12 months of follow-up in the two groups. Data
from 12 months of follow-up were used to assess both quality of life and the anatomical
outcomes, because of the greater practical applicability of the outcomes. However,
the authors consider the follow-up of patients to assess long-term efficacy, which
was not the objective of the present study. For the assessment of cure ranges, two
specific clinical criteria were used: according to the first criterion, those with
the highest prolapse point lower than −1 according to the POP-Q were considered cured
(stage I). Then, in the second criterion, patients were regrouped and considered cured
when the point of greatest prolapse was ≤ 0, (stage II).[8 ]
The duration of the surgery (time from the first incision to the completion of the
suture) and blood loss (hemoglobin and hematocrit levels) were also analyzed pre-
and postoperatively. Complications were described according to the terminology of
the International Urogynecological Association (IUGA) and ICS.[13 ]
The sample size (N) was calculated based on the primary objective of the study. According
to the literature review, the authors estimated a minimum of 20 patients in each group,
with a difference of 25% between them. The level of rejection of the null hypothesis
was set at 0.05 or 5% (α ≤ 0,05) and the power of the sample, at 80%.[14 ] The statistical analyzes were performed using the IBM SPSS Statistics for Windows
(IBM Corp., Armonk, NY, United States), version 19.0, and the R software (R Foundation
for Statistical Computing, Vienna, Austria), version 2.11.1. Quantitative (numerical)
variables were calculated as mean, median, minimum and maximum, and standard deviation
values. The qualitative (categorical) variables were analyzed by calculating their
absolute and relative frequencies (percentage). The Student t - and Mann-Whitney tests were used to compare the continuous variables, and the Pearson
Chi-squared with the Fisher exact tests, to compare the categorical variables between
groups. Analysis of variance (ANOVA) was performed to compare the POP and the P-QoL
score between the 2 groups before and 12 months after surgery. The significance level
was set at 0.05.
Results
The two groups were homogeneous in terms of age, age at the onset of menopause, number
of pregnancies, vaginal or cesarean deliveries, body mass index (BMI), race, smoking
status, systemic arterial hypertension, diabetes mellitus, initial stage, previous
gynecological surgeries, presence of SUI or occult SUI ([Table 1 ]). After 12 months of follow-up, a significant improvement was observed in all anatomical
points after the surgeries in both groups ([Table 2 ]).
Table 1
Preoperative characteristics of the patients
USLS
SSFL
p
Age (years)
(min–max) ± SD
68.8
(50–88) ± 10.3
66.6
(53–80) ± 6.9
0.374ª
Parity
(min–max) ± SD
5,0
(1–14) ± 3.4
5,4
(0–15) ± 4.0
0.648a
Vaginal deliveries
(min–max) ± SD
4,1
(0–14) ± 3.6
4,2
(0–12) ± 3.5
0.864b
BMI (Kg/m2 )
(min–max) ± SD
26,2
(17.7–38.9) ± 4.7
25,8
(19.4–33.9) ± 3.2
0.760a
Race
0.068c
White
18 (69.2%)
19 (76%)
Non-white
8 (31.8%)
6 (24%)
POP-Q stage
0.312d
III
13 (50%)
9 (36%)
IV
13 (50%)
16 (64%)
Previous surgeries
5 (19.2%)
7 (28%)
0.460d
SUI
15 (57.8%)
16 (64%)
0.645d
Overactive bladder
21 (80.8%)
16 (64%)
0.180d
Occult SUI
3 (11.5%)
4 (12%)
> 0.999c
Abbreviations: BMI, Body Mass Index; min, minimum; max, maximum; POP-Q, Pelvic Organ
Prolapse Quantification System; SD, standard deviation; SSLF, sacrospinous ligament
fixation; SUI, stress urinary incontinence; USLS, uterosacral ligament suspension.
Notes: a Student t -test for independent samples; b Mann-Whitney test; c Fisher exact test or its extension; d Pearson Chi-squared test.
Table 2
Position of the anatomical points (POP-Q) pre- and postoperatively after 12 months
in both groups
Points
USLS
SSFL
p
Mean ± SD
Min/Max
Mean ± SD
Min/Max
Aa
Preop
2.77 ± 0,82
(0/3)
2.48 ± 1.23
(−1/3)
0.827
Postop
−1.15 ± 1.29
(−3/1)
−1.00 ± 1.41
(−3/1)
0.778
p
a
< 0.001
< 0.001
Ba
Preop
4.81 ± 1.44
(1/7)
4.76 ± 2.01
(0/8)
> 0.999
Postop
−1.00 ± 1.26
(−3/1)
−0.80 ± 1.58
(−3/2)
0.791
p
a
< 0.001
< 0.001
C
Preop
5.73 ± 1.54
(3/8)
6.56 ± 1.69
(4/10)
0.481
Postop
−5.46 ± 1.36
(−8/−2)
−5.72 ± 1.28
(−8/−3)
0.324
p
a
< 0.001
< 0.001
GH
Preop
5.15 ± 0.97
(3/6)
4.80 ± 1.12
(3/8)
0.487
Postop
3.31 ± 0.68
(2/5)
3.44 ± 0.71
(2/5)
0.594
p
a
< 0.001
< 0.001
PB
Preop
2.73 ± 0.67
(2/4)
3.04 ± 1.14
(2/7)
0.515
Postop
3.77 ± 0.65
(3/5)
3.80 ± 0.65
(3/5)
0.388
p
a
< 0.001
< 0.001
TVL
Preop
8.38 ± 0.70
(7/10)
8.36 ± 0.76
(7/10)
> 0.999
Postop
7.04 ± 1.00
(5/9)
6.92 ± 1.38
(4/9)
0.951
p
a
< 0.001
< 0.001
Ap
Preop
0.96 ± 1.87
(−2/3)
1.56 ± 1.85
(−3/3)
0.481
Postop
−2.19 ± 1.10
(−3/1)
−2.60 ± 0.87
(−3/0)
0.105
p
a
< 0.001
< 0.001
Bp
0.141
Preop
2.08 ± 2.86
(−2/6)
3.36 ± 2.45
(−3/8)
Postop
−1.92 ± 1.41
(−3/2)
−2.48 ± 1.33
(−3/3)
0.043*
p
a
< 0.001
< 0.001
Abbreviations: GH, Genital Hiatus; Min, minimum; Max, maximum; PB, Perineal Body;
POP-Q, Pelvic Organ Prolapse Quantification System; Postop, postoperatively; Preop,
preoperatively; SD, Standard Deviation; SSLF, sacrospinous ligament fixation; TVL,
Total Vaginal Length; USLS, uterosacral ligament suspension.
Notes: Values expressed in centimeters (mean ± standard deviation, and minimum and
maximum values); a Analysis of variance (ANOVA).
In the evaluation of the compartments, separately, after 12 months of follow-up, with
the adoption of anatomical healing patterns of points in a position lower than −1,
anatomical cure rates of 34.6% and 40% (for the USLS and SSLF groups respectively)
in the anterior compartment and of 100% for both groups in the apical compartment
were observed. In the posterior compartment, anatomical healing rates of 73.1% and
92% were observed in the USLS and SSLF groups respectively, with a significant improvement
in the posterior compartment (Bp) favorable to the SSLF group (p = 0.043) ([Tables 2 ] and [3 ]).
Table 3
Cure rate using two different criteria of anatomical and functional cure: POP-Q < −1
or POP-Q ≤ 0
POP-Q
USLS (N = 26)
N (%)
SSLF (N = 25)
N (%)
p
Ba < −1
9 (34.6%)
10 (40.0%)
0.691a
Ba ≤ 0
23 (88.4%)
21 (84.0%)
0.703a
C < −1
26 (100.0%)
25 (100.0%)
*
C ≤ 0
26 (100.0%)
25 (100.0%)
*
Bp < 1
19 (73.1%)
23 (92.0%)
0.140b
Bp ≤ 0
23 (88.4%)
24 (96.0%)
0.610b
Abbreviations: POP-Q, Pelvic Organ Prolapse Quantification System; SSLF, sacrospinous
ligament fixation; USLS, uterosacral ligament suspension.
Notes: a Pearson Chi-Squared test; b Fisher exact test; *Impossibility of performing a statistical analysis for total cure
in both groups.
On the other hand, when adopting the presence of prolapse up to the hymenal caruncle
as a cure criterion, that is, Ba, Bp or C ≤ 0, we observed cure rates of 88.4% and
84% (for the USLS and SSLF groups respectively) in the anterior compartment, of 88.4%
(USLS group) and 96% (SSLF group) in the posterior compartment, and of 100% (both
groups) in the apical compartment, with no statistical difference between techniques
([Table 3 ]). Therefore, when analyzing the anatomical measurements of the compartments, there
was a favorable statistical difference in the SSLF group (posterior compartment),
without statistical difference between the groups when analyzing the cure rates. Using
the P-QoL, we observed that, after 12 months of follow-up, both procedures were efficient,
with a significant improvement in scores in the nine domains evaluated regarding the
postoperative and preoperative periods. There were no significant differences when
comparing both groups after 12 months of follow-up ([Table 4 ]).
Table 4
Preoperative and postoperative P-QOL scores of women who underwent fixation of the
vaginal vault through SSLF USLS
USLS
SSLF
pa
Mean ± SD
Mean ± SD
General health perception
0.970
0.514
Preop
49.0 ± 26.9
52.0 ± 24.9
Postop
31.7 ± 24.0
22.0 ± 18.1
pb
< 0.001
< 0.001
Prolapse impact
0.994
0.739
Preop
74.3 ± 36.8
76.3 ± 29.6
Postop
8.9 ± 27.5
1.3 ± 6.6
pb
< 0.001
< 0.001
Role limitations
0.555
Preop
58.9 ± 38.9
47.4 ± 40.1
Postop
7.6 ± 27.1
0.6 ± 3.3
0.171
pb
< 0.001
< 0.001
Physical limitations
0.444
0.297
Preop
Postop
60.9 ± 39.4
5.1 ± 20.4
48.0 ± 42.0
1.3 ± 6.6
pb
< 0.001
< 0.001
Social limitations
0.771
Preop
44.8 ± 39.8
36.8 ± 38.7
Postop
0.9 ± 4.5
0.89 ± 4.4
0.204
pb
< 0.001
< 0.001
Personal relationships
0.463
Preop
14.1 ± 30.4
24.0 ± 36.3
Postop
1.2 ± 6.5
1.3 ± 6.6
0.371
pb
< 0.001
< 0.001
Emotions
Preop
62.8 ± 40.9
64.4 ± 37.9
> 0.999
Postop
4.7 ± 19.6
1.3 ± 22.2
0.799
pb
< 0.001
< 0.001
Sleep/Energy
0.295
Preop
39.1 ± 34.2
27.1 ± 28.5
Postop
5.7 ± 15.5
2.6 ± 10.4
pb
< 0.001
< 0.001
0.146
Severity measures
0.850
Preop
43.2 ± 32.4
48.3 ± 31.5
Postop
1.9 ± 1.3
1.3 ± 5.2
0.493
pb
< 0.001
< 0.001
Abbreviations: P-QoL, Prolapse Quality of Life questionnaire; Preop, preoperative
period; Postop, postoperative period; SD, standard deviation; SSLF, sacrospinous ligament
fixation; USLS, uterosacral ligament suspension.
Note: a,b Analysis of variance (ANOVA).
The mean duration of the surgery was of 137.6 (range: 80 to 190) minutes in the USLS
group, and of 146.9 (range: 80 to 215) minutes in the SSFL group, with no difference
between them (p = 0.299) ([Table 5 ]). There was no statistical differences between the groups regarding the minimal
incidence of intraoperative or postoperative complications ([Table 6 ]). Subjective cure was determined by the P-QoL, and there was no difference between
the groups.
Table 5
Comparison of perioperative results between the USLS and SSFL groups
Variables
USLS Group
SSFL Group
p
Mean ± SD
Min-max
Mean ± SD
Min-max
Operative Time (minutes)
137.6 ± 29.5
80–190
133.5 ± 33.7
80–215
0.299
Hemoglobin (g/dL)
Preop
13.1 ± 1.1
11.0–15.7
13.1 ± 1.1
10.7–15.4
0.482
Postop
10.8 ± 1.2
8.6–13.5
11.2 ± 1.6
8.3–14.1
0.448
Hematocrit (%)
Preop
39.1 ± 3.4
34.0–47.4
39.1 ± 3.1
33.6–47.0
0.571
Postop
32.3 ± 3.7
26.0–40.0
33.4 ± 4.7
24.7–42.6
0.415
Hospital stay (days)
2.3 ± 0.8
2.0–5.0
2.2 ± 0.8
1.0–5.0
0.559
Abbreviations: Min, minimum; max, maximum; Preop, preoperative period; Postop, postoperative
period; SD, standard deviation; SSFL, sacrospinous ligament fixation; USLS, uterosacral
ligament suspension.
Notes: Values expressed as mean ± standard deviation; hemoglobin and hematocrit levels
collected 24 hours after surgery through analysis of variance (ANOVA) with parametric
repeated measures.
Table 6
Total number of complications in both groups
USLS
SSLF
pa
Intraoperative
Excessive bleeding
3
1
–
Transfusion
–
–
–
Bladder perforation
–
–
–
Postoperative
Gluteal pain
–
5
–
Infection
3
1
–
De novo overactive bladder
1
–
–
Thigh paresthesia
1
–
–
Urinary infection
2
3
–
Dyspareunia
1
–
–
Rectal injury (47th postoperative day)b
–
1
–
Total
11
11
0.654a
Abbreviations: SSLF, sacrospinous ligament fixation; USLS, uterosacral ligament suspension.
Notes: a Pearson Chi-squared test; b one patient in the SSFL group had an acute abdomen on the 47th postoperative day,
with a diagnosis of a perforation lesion measuring ∼ 5 cm, located in the middle rectum.
The patient underwent exploratory laparotomy with resection of the lesion and colostomy
with reconstruction of the intestinal transit in the second stage. The anatomopathological
study showed circulatory disturbance, probably due to ischemic injury.
Discussion
The present study evaluated the two most commonly performed surgical correction techniques,
one of which is the reconstruction of the pelvic anatomy using native tissues, and
the degree of objective (anatomical) and subjective (functional) success in achieving
satisfactory results with respect to the most current recommendations on the surgical
treatment of POP.[2 ]
[3 ]
[4 ]
[9 ]
[15 ]
[16 ]
Systematic reviews, randomized trials and medical societies found no evidence to support
the use of meshes to the detriment of native tissues.[2 ]
[3 ]
[4 ]
[15 ]
[16 ]
[17 ] Since 2011,[7 ] many transvaginal mesh products have been removed from the market after the Food
and Drug Administration (FDA) announcement that identified serious safety, effectiveness
concerns, and complications with the use of transvaginal mesh to treat POP. The outcomes
of the present study corroborate global analyzes and recommendations on the surgical
treatment for POP. Fortunately, VH and vaginal apex repair to the uterosacral or sacrospinous
ligaments (which are relatively low-risk surgeries) are effective treatments for most
women with apical POP, according to several authors and supported by renowned medical
societies in the field, without the use of synthetic mesh.[2 ]
[3 ]
[4 ]
[9 ]
[15 ]
[16 ]
Studies such as the present, which prove the effectiveness of surgical treatment with
the application of traditional techniques in urogynecology, such as fixation of the
vaginal vault to the sacrospinous ligament or suspension of the uterosacral ligament
to correct even advanced apical prolapses, reinforce the prioritization of the choice
and reproducibility of the classic technique in urogynecological surgery for POP.[17 ]
[18 ]
[19 ]
[20 ] Thus, currently there is no indication for the use of screens.[17 ] In a systematic review published in 2016, Maher et al.[17 ] found no evidence to support the use of meshes to the detriment of native tissues,
which is in line with the results of the present study. The practical applicability
of these results enables the advancement and dissemination of knowledge regarding
surgical techniques in traditional urogynecology, without detriment to technologies,
but with the deserved reservations.[18 ]
[19 ]
[20 ]
Regarding the cure criteria, there is no consensus in the scientific community on
success and failure in POP correction surgery. Barber et al.[8 ] (2009), after a 2-year follow-up of 322 patients in the Colpopexy and Urinary Reduction
Efforts (CARE) study, applied 18 different definitions of success after surgery for
the correction of POP in stages II to IV, and the treatment success rate varied widely
depending on the definition used (range: 19.2% to 97.2%).
In that context, the POP-Q enables more accurate descriptions of the POP stages for
diagnosis and follow-up. Despite the fact that most patients are classified as stage
II postoperatively, with a surgical outcome between the +1 and −1 range of the hymenal
ring, they generally remain asymptomatic. Therefore, what would configure an anatomical
failure (stage II according to the POP-Q) is classified as a cure according to the
patient's subjective criteria, particularly when the prolapse is axial to the hymenal
point.[8 ]
[21 ]
[22 ]
Based on this scenario, the results of the present study (anterior compartment), showed
questionable anatomical cure rates in both groups after one year of follow-up, when
considering the cure criterion points of greater POP-Q prolapse below −1 (34.6% and
40%, for USLS and SSLF groups respectively). However, when adopting the hymenal ring
as a reference point for healing (Ba ≤ 0), since these patients are asymptomatic,
the cure rates were of 88.4% (USLS) and 88% (SSLF).
In the same direction, Barber et al.[23 ] (2014) compared patients in stages II to IV submitted to SSLF (N = 186) and USLS (N = 188), with 2 years of follow-up, and observed recurrence rates of 13.7% and 15.5%
respectively, considering Ba > 0. Then, the results of the present study were similar
to the work by Barber et al.[23 ], who, after 2 years of follow-up, observed surgical success rates of 59.2% for uterosacral
fixation and of 60.5% for sacrospinal fixation, with no difference between the two
techniques.
However, Meyer et al.[24 ] (2020), when reanalyzing data from that study only with patients in stages III and
IV, found anterior wall recurrence rates of 16.8% (SSLF) and 17.9% (USLS), and a high
rate of patient satisfaction in both groups according to the P-QoL.
The analysis of the apical compartment after the interventions points to the restoration
of the anatomy in both groups, with no significant difference. These findings corroborate
those of previous studies[2 ]
[3 ]
[4 ]
[15 ]
[16 ] and enable us to demonstrate that both techniques yield satisfactory surgical outcomes.
Choosing to ignore less-rigid cure criteria in the treatment of advanced apical prolapse
can provide satisfactory anatomical and surgical outcomes for the patient, especially
when native tissues are used for pelvic reconstruction.
On the other hand, in the posterior compartment, a better anatomical result was observed
in the SSLF group, with a statistical difference, but no difference in terms of the
subjective assessment. This was probably due to to posterior deviation of the vaginal
axis: the greater the area of dissection of the posterior compartment, the better
the anatomical correction.[24 ]
In both groups, there was a significant decrease in the size and width of the genital
hiatus after reconstruction of the posterior compartment and perineal body, which
is considered a high-impact factor in surgical success and decreased recurrence. Inadequate
correction of the genital hiatus can therefore impair the surgical outcome in addition
to resulting in recurrence of the prolapse.[25 ]
[26 ]
This randomized design, approved by ethics committees and clinical trials plataforms,
highlights the methodological rigor and positive impact by offering reliability and
resilience of site-specific surgical treatment in advanced POP, in a paradoxical technological
appeal and numerous restrictions to synthetic meshes. Synthetic meshes may have their
clinical applicability; however, it is increasingly limited due to the high rate of
complications.[2 ]
[3 ]
[4 ]
[7 ]
[9 ]
[21 ]
The recommendation to use classic techniques for POP correction is in line with reference
medical societies, such as the IUGA,[9 ] the American College of Obstetricians and Gynecologists (ACOG),[2 ] the International Federation of Gynecology and Obstetrics (Fédération Internationale
de Gynécologie et d'Obstétrique, FIGO, in French),[3 ] the American Urogynecologic Society (AUGS),[9 ] as well as regulatory agencies (such as the FDA).[7 ] Besides that, the present study emphasizes a subjective criterion of cure, valued
by the person most interested in the subject, the patient, without detriment to the
anatomical criterion.
On the other hand, sample size and sexual function data (most patients no longer had
an active sexual life) may be limitations of the present study which may not compromise
the scientific quality. The authors believe that the parity of positive cure outcomes
analyzed by different anatomical methods, as well as the application of the P-QoL,
reinforces the data and alleviates the limitation of the sample. Besides that, due
to the objective being the comparison of cure criteria, not the assessment of the
superiority or inferiority of a technique, the sample was sufficient according to
the statistical recommendation.
The authors point to the need for longer follow-up of patients (undergoing evaluations
to provide data for future studies) with a more robust sample from multiple centers
to really assess the potential for POP recurrence between the groups.
Due to the current restrictions on the use of synthetic meshes by specialized medical
societies, regulatory agencies and several authors, reconstructive pelvic surgery
might be moving toward a return to the classic use of native tissues, even in cases
o POP in advanced stages.
Conclusion
Both techniques (SSLF and USLS) have high success rates, good satisfactory anatomical
and subjective outcomes, and a positive impact on the quality of life of patients
with apical POP in stages III and IV.
