Dataset Information

Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse: A Randomized Clinical Trial.

ABSTRACT:

Importance

Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Transvaginal mesh hysteropexy is an alternative option.

Objective

To compare the efficacy and adverse events of vaginal hysterectomy with suture apical suspension and transvaginal mesh hysteropexy.

Design, setting, participants

At 9 clinical sites in the US Pelvic Floor Disorders Network, 183 postmenopausal women with symptomatic uterovaginal prolapse were enrolled in a randomized superiority clinical trial between April 2013 and February 2015. The study was designed for primary analysis when the last randomized participant reached 3 years of follow-up in February 2018.

Interventions

Ninety-three women were randomized to undergo vaginal mesh hysteropexy and 90 were randomized to undergo vaginal hysterectomy with uterosacral ligament suspension.

Main outcomes and measures

The primary treatment failure composite outcome (re-treatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival models. Secondary outcomes included operative outcomes and adverse events, and were evaluated with longitudinal models or contingency tables as appropriate.

Results

A total of 183 participants (mean age, 66 years) were randomized, 175 were included in the trial, and 169 (97%) completed the 3-year follow-up. The primary outcome was not significantly different among women who underwent hysteropexy vs hysterectomy through 48 months (adjusted hazard ratio, 0.62 [95% CI, 0.38-1.02]; P?=?.06; 36-month adjusted failure incidence, 26% vs 38%). Mean (SD) operative time was lower in the hysteropexy group vs the hysterectomy group (111.5 [39.7] min vs 156.7 [43.9] min; difference, -45.2 [95% CI, -57.7 to -32.7]; P?=?<.001). Adverse events in the hysteropexy vs hysterectomy groups included mesh exposure (8% vs 0%), ureteral kinking managed intraoperatively (0% vs 7%), granulation tissue after 12 weeks (1% vs 11%), and suture exposure after 12 weeks (3% vs 21%).

Conclusions and relevance

Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, vaginal mesh hysteropexy compared with vaginal hysterectomy with uterosacral ligament suspension did not result in a significantly lower rate of the composite prolapse outcome after 3 years. However, imprecision in study results precludes a definitive conclusion, and further research is needed to assess whether vaginal mesh hysteropexy is more effective than vaginal hysterectomy with uterosacral ligament suspension.

Trial registration

ClinicalTrials.gov Identifier: NCT01802281.

SUBMITTER: Nager CW

PROVIDER: S-EPMC6749543 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse: A Randomized Clinical Trial.

Nager Charles W CW Visco Anthony G AG Richter Holly E HE Rardin Charles R CR Rogers Rebecca G RG Harvie Heidi S HS Zyczynski Halina M HM Paraiso Marie Fidela R MFR Mazloomdoost Donna D Grey Scott S Sridhar Amaanti A Wallace Dennis D

JAMA 20190901 11

<h4>Importance</h4>Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Transvaginal mesh hysteropexy is an alternative option.<h4>Objective</h4>To compare the efficacy and adverse events of vaginal hysterectomy with suture apical suspension and transvaginal mesh hysteropexy.<h4>Design, setting, participants</h4>At 9 clinical sites in the US Pelvic Floor Disorders Network, 183 postmenopausal women with symptomatic uterovaginal prolapse were enrolled ...[more]

PMID: 31529008

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Project description:BackgroundVaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Sacrospinous hysteropexy with graft (vaginal mesh hysteropexy) is an alternative, although in 2019 the Food and Drug Administration removed this mesh product from the United States market.ObjectiveOur objective was to compare the efficacy and adverse events of these 2 procedures.Study designAt 9 clinical sites in the United States National Institutes of Health and National Institute of Child Health and Human Development Pelvic Floor Disorders Network, 183 postmenopausal women requesting vaginal surgery for symptomatic uterovaginal prolapse were enrolled in a multisite randomized superiority clinical trial, comparing a sacrospinous hysteropexy with graft (hysteropexy) with a vaginal hysterectomy with uterosacral ligament suspension (hysterectomy). Participants consented to remain masked to treatment assignment for the study duration. Study visits were conducted at 6-month intervals through 60 months. The primary treatment failure composite outcome (retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival modeling. Secondary outcomes included complications or adverse events, individual anatomic measures of the pelvic organ prolapse quantification examination, and presence, severity, and impact and bother of prolapse, urinary, bowel, and pain symptoms as measured by validated questionnaires. The 3-year published results suggested better primary outcomes with sacrospinous hysteropexy with graft, but the differences were not statistically significant (P=.06). This study reports the 5-year outcomes.ResultsA total of 183 women with a mean age of 66 years were randomized between April 2013 and February 2015; 93 were randomized to hysteropexy and 90 were randomized to hysterectomy. Notably, 175 were included in the trial, and 156 (89%) completed the 5-year follow-up. The primary outcome showed fewer failures for hysteropexy than hysterectomy through 5 years (adjusted hazard ratio, 0.58; 95% confidence interval, 0.36-0.94; P=.03), with failure rates of 37% vs 54%, respectively, resulting in a difference of -18% (95% confidence interval, -33% to -3%) at 5 years. With the exception of the Urogenital Distress Inventory, no group differences were demonstrated in patient-reported pelvic floor symptoms, prolapse symptoms, bowel function symptoms, general quality of life, body image, or pelvic pain. At their last visit through 5 years, 70% of participants (129 of 183) reported they remained masked to their treatment with no difference in masking between groups. Adverse events for hysteropexy vs hysterectomy included mesh exposure (8% vs 0%), granulation tissue after 12 weeks (1% vs 12%), and suture exposure after 12 weeks (3% vs 21%), respectively.ConclusionAmong women with symptomatic uterovaginal prolapse undergoing vaginal surgery, sacrospinous hysteropexy with graft resulted in a lower composite failure rate than vaginal hysterectomy through 5 years. There were no meaningful differences in patient-reported outcomes between groups. Our results suggest that this vaginal mesh hysteropexy procedure should be made available to patients.

Project description:IntroductionLaparoscopic sacral colpopexy is the gold standard technique for apical prolapse correction but it is a technically challenging procedure with rare but severe morbidity. Laparoscopic high uterosacral ligament suspension could be a valid technically easier alternative using native tissue.Material and methodsIn the period from 2015 to 2018, 600 women were submitted to laparoscopic sacral colpopexy while 150 to laparoscopic high uterosacral ligament suspension in three Italian urogynecology referral centers. We enrolled women with apical prolapse stage ≥2 alone or multicompartment descensus. To reduce allocation bias, we performed a propensity matched analysis. Women undergoing laparoscopic high uterosacral ligament suspension surgery were matched 1:2 to women undergoing laparoscopic sacral colpopexy. The cumulative proportion of relapse-free women in time was analyzed by the Kaplan-Meier method. The primary objective of this multicenter case-control retrospective study was to compare the recurrence rate while the secondary objectives were to compare feasibility, safety, and efficacy of laparoscopic sacral colpopexy and laparoscopic high uterosacral ligament suspension in surgical treatment of pelvic organ prolapse.ResultsThree hundred and nine women were enrolled (103 laparoscopic high uterosacral ligament suspension; 206 laparoscopic sacral colpopexy). Median operatory time was significantly shorter in the laparoscopic high uterosacral ligament suspension group (P = 0.0001). No statistically significative difference was found in terms of estimated blood loss, admission time, intraoperative, and major early postoperative complications, postoperative pelvic pain, dyspareunia and de novo stress urinary incontinence. Surgical approach was the only independent risk factor for prolapse recurrence (RR = 6.013 [2.965-12.193], P = 0.0001). The objective cure rate was higher in the laparoscopic sacral colpopexy group (93.7 vs. 68%, 193/206 vs. 70/103, P = 0.0001) with a highly reduced risk of recurrence (RR = 5.430 [1.660-17.765]). Median follow up was 22 months.ConclusionBoth techniques are safe, feasible, and effective. Laparoscopic sacral colpopexy remains the best choice in treatment of multicompartment and advanced pelvic organ prolapse while laparoscopic high uterosacral ligament suspension could be appropriate for moderate and isolated apical prolapse when laparoscopic sacral colpopexy is not suitable for the patient or to prevent prolapse in women at high risk at the time of the hysterectomy.

Project description:Importance:Uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) are commonly performed pelvic organ prolapse procedures despite a lack of long-term efficacy data. Objective:To compare outcomes in women randomized to (1) ULS or SSLF and (2) usual care or perioperative behavioral therapy and pelvic floor muscle training (BPMT) for vaginal apical prolapse. Design, Setting, and Participants:This 2 × 2 factorial randomized clinical trial was conducted at 9 US medical centers. Eligible participants who completed the Operations and Pelvic Muscle Training in the Management of Apical Support Loss Trial enrolled between January 2008 and March 2011 and were followed up 5 years after their index surgery from April 2011 through June 2016. Interventions:Two randomizations: (1) BPMT (n = 186) or usual care (n = 188) and (2) surgical intervention (ULS: n = 188 or SSLF: n = 186). Main Outcomes and Measures:The primary surgical outcome was time to surgical failure. Surgical failure was defined as (1) apical descent greater than one-third of total vaginal length or anterior or posterior vaginal wall beyond the hymen or retreatment for prolapse (anatomic failure), or (2) bothersome bulge symptoms. The primary behavioral outcomes were time to anatomic failure and Pelvic Organ Prolapse Distress Inventory scores (range, 0-300). Results:The original study randomized 374 patients, of whom 309 were eligible for this extended trial. For this study, 285 enrolled (mean age, 57.2 years), of whom 244 (86%) completed the extended trial. By year 5, the estimated surgical failure rate was 61.5% in the ULS group and 70.3% in the SSLF group (adjusted difference, -8.8% [95% CI, -24.2 to 6.6]). The estimated anatomic failure rate was 45.6% in the BPMT group and 47.2% in the usual care group (adjusted difference, -1.6% [95% CI, -21.2 to 17.9]). Improvements in Pelvic Organ Prolapse Distress Inventory scores were -59.4 in the BPMT group and -61.8 in the usual care group (adjusted mean difference, 2.4 [95% CI, -13.7 to 18.4]). Conclusions and Relevance:Among women who had undergone vaginal surgery for apical pelvic organ vaginal prolapse, there was no significant difference between ULS and SSLF in rates of surgical failure and no significant difference between perioperative behavioral muscle training and usual care on rates of anatomic success and symptom scores at 5 years. Compared with outcomes at 2 years, rates of surgical failure increased during the follow-up period, although prolapse symptom scores remained improved. Trial Registration:clinicaltrials.gov Identifier: NCT01166373.

Dataset Information

Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse: A Randomized Clinical Trial.

Importance

Objective

Design, setting, participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse: A Randomized Clinical Trial.

Similar Datasets

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