Cited by 339Pelvic floor disorders treatmentsUrinary Bladder and Prostate ResearchUreteral procedures and complications

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A Midurethral Sling to Reduce Incontinence after Vaginal Prolapse Repair

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Wei, John T., Nygaard, Ingrid, Richter, Holly E., Nager, Charles W., Barber, Matthew D., Kenton, Kim, Amundsen, Cindy L., Schaffer, Joseph, Meikle, Susan F., Spino, Cathie·2012·New England Journal of Medicine

DOI 10.1056/nejmoa1111967PMC PMC3433843

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Abstract

BACKGROUND: Women without stress urinary incontinence undergoing vaginal surgery for pelvic-organ prolapse are at risk for postoperative urinary incontinence. A midurethral sling may be placed at the time of prolapse repair to reduce this risk. METHODS: We performed a multicenter trial involving women without symptoms of stress incontinence and with anterior prolapse (of stage 2 or higher on a Pelvic Organ Prolapse Quantification system examination) who were planning to undergo vaginal prolapse surgery. Women were randomly assigned to receive either a midurethral sling or sham incisions during surgery. One primary end point was urinary incontinence or treatment for this condition at 3 months. The second primary end point was the presence of incontinence at 12 months, allowing for subsequent treatment for incontinence. RESULTS: Of the 337 women who underwent randomization, 327 (97%) completed follow-up at 1 year. At 3 months, the rate of urinary incontinence (or treatment) was 23.6% in the sling group and 49.4% in the sham group (P<0.001). At 12 months, urinary incontinence (allowing for subsequent treatment of incontinence) was present in 27.3% and 43.0% of patients in the sling and sham groups, respectively (P=0.002). The number needed to treat with a sling to prevent one case of urinary incontinence at 12 months was 6.3. The rate of bladder perforation was higher in the sling group than in the sham group (6.7% vs. 0%), as were rates of urinary tract infection (31.0% vs. 18.3%), major bleeding complications (3.1% vs. 0%), and incomplete bladder emptying 6 weeks after surgery (3.7% vs. 0%) (P≤0.05 for all comparisons). CONCLUSIONS: A prophylactic midurethral sling inserted during vaginal prolapse surgery resulted in a lower rate of urinary incontinence at 3 and 12 months but higher rates of adverse events. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women's Health; OPUS ClinicalTrials.gov number, NCT00460434.).

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Authors: Wei, J. T., Nygaard, I., Richter, H. E., Nager, C. W., Barber, M. D., Kenton, K., Amundsen, C. L., Schaffer, J., Meikle, S. F., & Spino, C.
Affiliations: University of Michigan (US)
University of Utah (US)
University of Alabama at Birmingham (US)
University of California San Diego (US)
Cleveland Clinic (US)
Loyola University Chicago (US)
Duke University (US)
The University of Texas Southwestern Medical Center (US)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (US)
ORCID: Richter, Holly E.
Nager, Charles W.
Kenton, Kim
Amundsen, Cindy L.
Spino, Cathie
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2012-06-21
Volume: 366
Issue: 25
Pages: 2358-2367
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1111967
PMC: PMC3433843
OpenAlex: W2020655201
Cited by: 339
References: 17
Citations by year: 2026: 20 · 2025: 11 · 2024: 18 · 2023: 20 · 2022: 18 · 2021: 20 · 2020: 25 · 2019: 28 · 2018: 34 · 2017: 39 · 2016: 29 · 2015: 19 · 2014: 22 · 2013: 24 · 2012: 10
FWCI: 18.23
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
Funders: Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10HD041261, U10HD054136, U10HD054214, U01HD041249, U10HD054215, U10HD041267, U10HD054241, U10HD041250)
Topics: Health Sciences › Medicine › Urology › Pelvic floor disorders treatments
Health Sciences › Medicine › Urology › Urinary Bladder and Prostate Research
Health Sciences › Medicine › Urology › Ureteral procedures and complications
Keywords: midurethral sling, stress urinary incontinence, postoperative urinary incontinence, vaginal prolapse repair, anterior pelvic organ prolapse, bladder perforation, urinary tract infection, surgical complications
MeSH terms: Aged, Urinary Bladder, Female, Follow-Up Studies, Hemorrhage, Humans, Intraoperative Complications, Middle Aged, Postoperative Complications, Surgical Mesh, Urinary Incontinence, Uterine Prolapse

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A Midurethral Sling to Reduce Incontinence after Vaginal Prolapse Repair

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