Evidence map›Paper›PMID 31201809›Full record

Trial reportAmerican journal of obstetrics and gynecology2019

Pain and activity after vaginal reconstructive surgery for pelvic organ prolapse and stress urinary incontinence.

Matthew D Barber, Linda Brubaker, Ingrid Nygaard, Clifford Y Wai, Keisha Y Dyer, David Ellington, Amaanti Sridhar, Marie G Gantz, NICHD Pelvic Floor Disorders Network

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in American journal of obstetrics and gynecology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
2.2field-weighted citation impact, top 13% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 1 country.

Matthew D BarberDepartment of Obstetrics and Gynecology, Duke University Medical Center, Durham NC. Electronic address: matthew.barber@duke.edu.
Linda BrubakerDepartment of Obstetrics, Gynecology, and Reproductive Sciences, University of California-San Diego, San Diego CA.
Ingrid NygaardDepartment of Obstetrics and Gynecology, University of Utah, Salt Lake City, UT.
Clifford Y WaiDepartment of Obstetrics and Gynecology, University of Texas-Southwestern, Dallas TX.
Keisha Y DyerDepartment of Obstetrics and Gynecology, Kaiser Permanente, San Diego, CA.
David EllingtonDepartment of Obstetrics and Gynecology, University of Alabama-Birmingham, Birmingham AL.
Amaanti SridharDepartment of Social, Statistical, and Environmental Sciences, RTI International, Research Triangle Park, NC.
Marie G GantzDepartment of Social, Statistical, and Environmental Sciences, RTI International, Research Triangle Park, NC.
NICHD Pelvic Floor Disorders Network
RTI International · USUniversity of Alabama at Birmingham · USDuke Medical Center · USKaiser Permanente San Diego Medical Center · USThe University of Texas Southwestern Medical Center · USUniversity of California, San Diego · USUniversity of Utah · US

Funding

Pelvic Floor Disorders Network Data Coordinating Center Administrative Supplement: ODSS CDE FundingU24HD069031 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI MARIE G GANTZ · 2016 to 2026
$35.8M
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 2021UG1HD054241 · NICHD · UT SOUTHWESTERN MEDICAL CENTER · PI David Dwight Rahn · 2016 to 2026
$3.0M
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
Duke University Medical Center (DUMC) Pelvic Floor Disorders Network (PFDN) Clinical SiteUG1HD041267 · NICHD · DUKE UNIVERSITY · PI NAZEMA Y SIDDIQUI · 2016 to 2026
$2.8M
NICHD Pelvic Floor Disorders Network Clinical Sites (U10)U10HD054241 · NICHD · UT SOUTHWESTERN MEDICAL CENTER · PI SCHAFFER, JOSEPH I · 2006 to 2015
$1.9M
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 U24 HD069031NICHD NIH HHS UG1 HD041261NICHD NIH HHS UG1 HD041267NICHD NIH HHS UG1 HD054214NICHD NIH HHS UG1 HD054241
6 · The paper itself

Abstract

backgroundLittle is known about short- and long-term pain and functional activity after surgery for pelvic organ prolapse.

objectiveThe objectives of the study were to describe postoperative pain and functional activity after transvaginal native tissue reconstructive surgery with apical suspension and retropubic synthetic midurethral sling and to compare these outcomes between patients receiving 2 common transvaginal prolapse repairs, uterosacral ligament, and sacrospinous ligament vaginal vault suspension. STUDY

designThis planned secondary analysis of a 2 × 2 factorial randomized trial included 374 women randomized to receive uterosacral (n = 188) or sacrospinous (n = 186) vaginal vault suspension to treat both stages 2-4 apical vaginal prolapse and stress urinary incontinence between 2008 and 2013 at 9 medical centers. Participants were also randomized to receive perioperative pelvic muscle therapy or usual care. All patients received transvaginal native tissue repairs and a midurethral sling. Participants completed the Surgical Pain Scales (0-10 numeric rating scales; higher scores = greater pain) and Activity Assessment Scale (0-100; higher score = higher activity) prior to surgery and at 2 weeks, 4-6 weeks, and 3 months postoperatively. The MOS 36-item Short-Form Health Survey was completed at baseline and 6, 12, and 24 months after surgery; the bodily pain, physical functioning, and role-physical subscales were used for this analysis (higher scores = less disability). Self-reported pain medication use was also collected.

resultsBefore surgery, average pain at rest and during normal activity were (adjusted mean ± SE) 2.24 ± 0.23 and 2.76 ± 0.25; both increased slightly from baseline at 2 weeks (+0.65, P = .004, and +0.74, P = .007, respectively) and then decreased below baseline at 3 months (-0.87 and -1.14, respectively, P < .001), with no differences between surgical groups. Pain during exercise/strenuous activity and worst pain decreased below baseline levels at 4-6 weeks (-1.26, P = .014, and -0.95, P = .002) and 3 months (-1.97 and -1.50, P < .001) without differences between surgical groups. Functional activity as measured by the Activity Assessment Scale improved from baseline at 4-6 weeks (+9.24, P < .001) and 3 months (+13.79, P < .001). The MOS 36-item Short-Form Health Survey Bodily Pain, Physical Functioning, and Role-Physical Scales demonstrated significant improvements from baseline at 6, 12, and 24 months (24 months: +5.62, +5.79, and +4.72, respectively, P < .001 for each) with no differences between groups. Use of narcotic pain medications was reported by 14.3% of participants prior to surgery and 53.7% at 2 and 26.1% at 4-6 weeks postoperatively; thereafter use was similar to baseline rates until 24 months when it decreased to 6.8%. Use of nonnarcotic pain medication was reported by 48.1% of participants prior to surgery, 68.7% at 2 weeks, and similar to baseline at 3 months; thereafter use dropped steadily to 26.6% at 2 years. Uterosacral ligament suspension resulted in less new or worsening buttock pain than sacrospinous suspension at 4-6 weeks postoperatively (4.6% vs 10.5%, P = .043) but no difference in groin or thigh pain.

conclusionPain and functional activity improve for up to 2 years after native tissue reconstructive surgery with uterosacral or sacrospinous vaginal vault suspension and midurethral sling for stages 2-4 pelvic organ prolapse. On average, immediate postoperative pain is low and improves to below baseline levels by 4-6 weeks.

Indexed as

Pain MeasurementAnalgesicsExerciseFemaleGynecologic Surgical ProceduresHumansPelvic Organ ProlapsePostoperative PainSuburethral SlingsUrinary Incontinence, StressAnalgesicsfunctional activitypelvic floor disorderspelvic organ prolapsepostoperative painsacrospinous ligament fixationstress urinary incontinenceuterosacral ligament suspensionvaginal reconstructive surgery

Identifiers

PMID31201809
PMCPMC7250460
OpenAlexW2952924611

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Registered trials

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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.