Evidence map›Paper›PMID 27159758›Full record

Trial reportObstetrics and gynecology2016

Quality of Life and Sexual Function 2 Years After Vaginal Surgery for Prolapse.

Emily S Lukacz, Lauren Klein Warren, Holly E Richter, Linda Brubaker, Matthew D Barber, Peggy Norton, Alison C Weidner, John N Nguyen, Marie G Gantz

Erratum issued Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Obstetrics and gynecology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00597935 (Operations and Pelvic Muscle Training in the Management of Apical Support Loss), which is not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
8.4field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00597935 nacompletednot on this map

Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial: A Randomized Trial of Sacrospinous Ligament Fixation (SSLF) Versus Uterosacral Ligament Suspension (ULS) With and Without Perioperative Behavioral Therapy/Pelvic Muscle Training

TypeinterventionalSponsorNICHD Pelvic Floor Disorders NetworkRan2008 to 2013Enrolled374ConditionsPelvic Organ Prolapse (POP)ArmsSSLF, ULS, PMT
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 68 citations in OpenAlex.

  1. Pooled it
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  18. Pelvic organ prolapse and sexual function.Nature reviews. Urology · 2020
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Emily S LukaczDepartment of Reproductive Medicine, University of California San Diego Health Systems, San Diego, California; Social, Statistical & Environmental Sciences, RTI International, Research Triangle Park, North Carolina; the Departments of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama, University of Utah Medical Center, Salt Lake City, Utah, Duke Medical Center, Durham, North Carolina, and Southern California Kaiser Permanente, Downey, California; the Department of Obstetrics and Gynecology and Urology, Loyola University Chicago Stritch School of Medicine, Chicago, Illinois; and Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland, Ohio.
Lauren Klein Warren
Holly E Richter
Linda Brubaker
Matthew D Barber
Peggy Norton
Alison C Weidner
John N Nguyen
Marie G Gantz
Southern States University · US

Funding

Pelvic floor Disorders Network-Data Coordinating CenterU01HD041249 · NICHD · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI WEI, JOHN T · 2001 to 2010
$19.8M
Pelvic Floor Disorders Network Data Coordinating Center (U01)U01HD069031 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI GANTZ, MARIE G · 2011 to 2015
$19.7M
Perioperative Pelvic Floor Rehab: A Rrandomized TrialU10HD041261 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI RICHTER, HOLLY E · 2001 to 2015
$5.1M
UNC Pelvic Floor Disorders Research CollaborativeU10HD041267 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI VISCO, ANTHONY G · 2001 to 2015
$5.0M
The Pelvic Floor Disorders NetworkU10HD041250 · NICHD · LOYOLA UNIVERSITY CHICAGO · PI BRUBAKER, LINDA · 2001 to 2015
$3.8M
Pelvic Floor Disorders NetworkU10HD054214 · NICHD · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI LUKACZ, EMILY S. · 2006 to 2015
$3.3M
The Cleveland Clinic Clinical SiteU10HD054215 · NICHD · CLEVELAND CLINIC LERNER COM-CWRU · PI BARBER, MATTHEW D · 2006 to 2015
$3.2M
Pelvic Floor Disorders Network Clinical Site Application: The San Diego PelvicFloor ConsortiumUG1HD054214 · NICHD · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI EMILY S. LUKACZ, Shawn A Menefee · 2016 to 2026
$2.9M
NICHD Pelvic Floor Disorders Network Clinical Sites (U10)U10HD054241 · NICHD · UT SOUTHWESTERN MEDICAL CENTER · PI SCHAFFER, JOSEPH I · 2006 to 2015
$1.9M
UTAH PELVIC FLOOR DISORDERS NETWORKU10HD054136 · NICHD · UNIVERSITY OF UTAH · PI NYGAARD, INGRID E · 2006 to 2015
$1.6M
University of Alabama at Birmingham: Pelvic Floor Disorders NetworkUG1HD041261 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI RICHTER, HOLLY E · 2016 to 2021
$1.4M
Cleveland Clinic Pelvic Floor Disorders Network Clinical SiteUG1HD054215 · NICHD · CLEVELAND CLINIC LERNER COM-CWRU · PI PARAISO, MARIE FIDELA · 2016 to 2020
$95k
NICHD NIH HHS U01 HD041249NICHD NIH HHS U01 HD069031NICHD NIH HHS U10 HD041250NICHD NIH HHS U10 HD041261NICHD NIH HHS U10 HD041267NICHD NIH HHS U10 HD054136NICHD NIH HHS U10 HD054214NICHD NIH HHS U10 HD054215NICHD NIH HHS U10 HD054241NICHD NIH HHS UG1 HD041261NICHD NIH HHS UG1 HD054214NICHD NIH HHS UG1 HD054215
6 · The paper itself

Abstract

objectiveTo longitudinally assess the effect of native tissue vaginal apical prolapse repair with anti-incontinence surgery on quality of life, sexual function, and body image between uterosacral and sacrospinous suspensions.

methodsA planned secondary analysis was performed on 374 women enrolled in a randomized trial of the two types of native tissue repair for apical prolapse. Condition-specific and generic quality of life, sexual function, overall and de novo dyspareunia, and body image were assessed using validated instruments at baseline; 6, 12, and 24 months postoperatively; and changes from baseline were assessed and compared between surgical groups. General linear mixed models were used for comparisons and clinically significant differences were assessed using minimum important differences.

resultsOf the women randomized, 82% had outcomes available at 2 years. Overall, clinically and statistically significant improvements in generic and condition-specific quality of life and sexual function were observed after surgery. Dyspareunia rates decreased from 25% to 16% by 24 months with only 3% of all women undergoing treatment. De novo dyspareunia occurred in 5% and 10% by 12 and 24 months, respectively. Body image scores also significantly improved from baseline. There were no clinically meaningful or statistically significant differences between groups for any of these outcomes (all P>.05).

conclusionNative tissue vaginal prolapse surgery results in statistically and clinically significant improvements in quality of life, sexual function, and body image at 24 months with no significant differences between uterosacral and sacrospinous suspensions. One in 10 women experience de novo dyspareunia but few requested treatment. CLINICAL

trial registrationClinicalTrials.gov, www.clinicaltrials.gov, NCT00597935.

Indexed as

Quality of LifeSuburethral SlingsBody ImageFemaleHumansMiddle AgedPostoperative PeriodSexual BehaviorSurveys and QuestionnairesUrinary IncontinenceUterine Prolapse

Identifiers

PMID27159758
PMCPMC4879084
OpenAlexW2372075305

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.