Abstract:Objective: To compare the effects of two surgical procedures for the correction of anterior vaginal wall prolapse (AVWP) on the lower urinary tract symptoms (LUTS) using symptom questionnaires and quality of life (QoL). Materials and Methods: One hundred women with Pelvic Organ Prolapse Quantification stage (POP-Q) ≥ 2 were randomly distributed in two preoperatory groups. The first group (mesh) (n = 45) received a polypropylene mesh (PM) implant and the control group (n = 55) was submitted to anterior colporra… Show more
“…Exposure rates have decreased successively in the last decade because of stricter patient selection, advancements in mesh compounds and design and improvement of surgical techniques. Importantly, exposure rarely requires further surgery [2,[13][14][15][16][17][20][21][22][23][24]. Our results are consistent with the literature, despite the relatively high mean age of our patients (70 years), which is associated with reduced estrogen levels and an increased risk for vaginal atrophy [19], which ultimately increases the risk for mesh exposure.…”
Section: Discussionsupporting
confidence: 88%
“…Since none of our patients required further surgery up to the follow-up, all exposures could be managed conservatively. The reported exposure rates in the literature range between 3.2 and 14% [2,[13][14][15][16][17][20][21][22][23][24][25]. Exposure rates have decreased successively in the last decade because of stricter patient selection, advancements in mesh compounds and design and improvement of surgical techniques.…”
Introduction and hypothesis
To evaluate the performance of mesh-augmented repair of anterior pelvic organ prolapse (POP) with or without apical vaginal wall involvement in women with recurrent or complex prolapse.
Methods
This multicenter cohort study included women undergoing surgery with Calistar S (Promedon, Argentina) for anterior POP between 2016 and 2018. The SCENIHR opinion was considered for patient selection, surgeon’s experience and choice of implant. Patients were prospectively invited to assess effectiveness and safety by anamnesis, validated questionnaires and pelvic examination. A composite endpoint defined by POP-Q ≤ 1, absence of a vaginal bulge symptom and repeated surgery for POP was used to define treatment success. Descriptive statistics were applied. McNemar or Wilcoxon signed rank tests were used as paired samples tests. The significance level was set at 5%.
Results
A total of 107 non-fertile women with a mean age of 70.6 years were enrolled. Ninety-three (86.9%) women presented with recurrent prolapse. The mean follow-up time was 18.5 months. Treatment success was achieved in 76% of cases according the composite endpoint, with 98% reaching POP-Q ≤ 1 and a significant improvement in quality of life (p < 0.001). Mesh exposure occurred in six (5.6%) patients, although none required further surgery. Four (3.7%) patients reported dyspareunia, and a single (0.9%) patient displayed a prominence due to mesh folding.
Conclusions
Mesh-augmented repair of anterior POP is effective and safe in women with recurrent or complex prolapse. Hence, in a select patient population, the benefits of mesh-augmented POP repair still outweigh the risks.
“…Exposure rates have decreased successively in the last decade because of stricter patient selection, advancements in mesh compounds and design and improvement of surgical techniques. Importantly, exposure rarely requires further surgery [2,[13][14][15][16][17][20][21][22][23][24]. Our results are consistent with the literature, despite the relatively high mean age of our patients (70 years), which is associated with reduced estrogen levels and an increased risk for vaginal atrophy [19], which ultimately increases the risk for mesh exposure.…”
Section: Discussionsupporting
confidence: 88%
“…Since none of our patients required further surgery up to the follow-up, all exposures could be managed conservatively. The reported exposure rates in the literature range between 3.2 and 14% [2,[13][14][15][16][17][20][21][22][23][24][25]. Exposure rates have decreased successively in the last decade because of stricter patient selection, advancements in mesh compounds and design and improvement of surgical techniques.…”
Introduction and hypothesis
To evaluate the performance of mesh-augmented repair of anterior pelvic organ prolapse (POP) with or without apical vaginal wall involvement in women with recurrent or complex prolapse.
Methods
This multicenter cohort study included women undergoing surgery with Calistar S (Promedon, Argentina) for anterior POP between 2016 and 2018. The SCENIHR opinion was considered for patient selection, surgeon’s experience and choice of implant. Patients were prospectively invited to assess effectiveness and safety by anamnesis, validated questionnaires and pelvic examination. A composite endpoint defined by POP-Q ≤ 1, absence of a vaginal bulge symptom and repeated surgery for POP was used to define treatment success. Descriptive statistics were applied. McNemar or Wilcoxon signed rank tests were used as paired samples tests. The significance level was set at 5%.
Results
A total of 107 non-fertile women with a mean age of 70.6 years were enrolled. Ninety-three (86.9%) women presented with recurrent prolapse. The mean follow-up time was 18.5 months. Treatment success was achieved in 76% of cases according the composite endpoint, with 98% reaching POP-Q ≤ 1 and a significant improvement in quality of life (p < 0.001). Mesh exposure occurred in six (5.6%) patients, although none required further surgery. Four (3.7%) patients reported dyspareunia, and a single (0.9%) patient displayed a prominence due to mesh folding.
Conclusions
Mesh-augmented repair of anterior POP is effective and safe in women with recurrent or complex prolapse. Hence, in a select patient population, the benefits of mesh-augmented POP repair still outweigh the risks.
IntroductionWe assessed outcome and outcome-measure reporting in randomised controlled trials evaluating surgical interventions for anterior-compartment vaginal prolapse and explored the relationships between outcome reporting quality with journal impact factor, year of publication, and methodological quality.MethodsWe searched the bibliographical databases from inception to October 2017. Two researchers independently selected studies and assessed study characteristics, methodological quality (Jadad criteria; range 1–5), and outcome reporting quality Management of Otitis Media with Effusion in Cleft Palate (MOMENT) criteria; range 1–6], and extracted relevant data. We used a multivariate linear regression to assess associations between outcome reporting quality and other variables.ResultsEighty publications reporting data from 10,924 participants were included. Seventeen different surgical interventions were evaluated. One hundred different outcomes and 112 outcome measures were reported. Outcomes were inconsistently reported across trials; for example, 43 trials reported anatomical treatment success rates (12 outcome measures), 25 trials reported quality of life (15 outcome measures) and eight trials reported postoperative pain (seven outcome measures). Multivariate linear regression demonstrated a relationship between outcome reporting quality with methodological quality (β = 0.412; P = 0.018). No relationship was demonstrated between outcome reporting quality with impact factor (β = 0.078; P = 0.306), year of publication (β = 0.149; P = 0.295), study size (β = 0.008; P = 0.961) and commercial funding (β = −0.013; P = 0.918).ConclusionsAnterior-compartment vaginal prolapse trials report many different outcomes and outcome measures and often neglect to report important safety outcomes. Developing, disseminating and implementing a core outcome set will help address these issues.
While transvaginal permanent mesh is associated with lower rates of awareness of prolapse, reoperation for prolapse, and prolapse on examination than native tissue repair, it is also associated with higher rates of reoperation for prolapse, stress urinary incontinence, or mesh exposure and higher rates of bladder injury at surgery and de novo stress urinary incontinence. The risk-benefit profile means that transvaginal mesh has limited utility in primary surgery. While it is possible that in women with higher risk of recurrence the benefits may outweigh the risks, there is currently no evidence to support this position.Limited evidence suggests that absorbable mesh may reduce rates of recurrent prolapse on examination compared to native tissue repair, but there was insufficient evidence on absorbable mesh for us to draw any conclusions for other outcomes. There was also insufficient evidence for us to draw any conclusions regarding biological grafts compared to native tissue repair.In 2011, many transvaginal permanent meshes were voluntarily withdrawn from the market, and the newer, lightweight transvaginal permanent meshes still available have not been evaluated within a RCT. In the meantime, these newer transvaginal meshes should be utilised under the discretion of the ethics committee.
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