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      Partially absorbable mesh or native tissue repair for pelvic organ prolapse: a randomized controlled trial

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          Abstract

          Introduction and hypothesis

          The objective was to compare medium-term efficacy and safety of a partially absorbable mesh kit and native tissue repair in pelvic organ prolapse (POP).

          Materials and methods

          Women with primary POP stage ≥ II were randomized to transvaginal trocar-guided partially absorbable mesh (81 women) or native tissue repair (82 women). Primary outcome was overall anatomical success (POP < stage II) at 24 months. Secondary outcomes were composite success, global improvement, and adverse events.

          Results

          Sixty-nine (85%) of the women allocated to partially absorbable mesh underwent mesh surgery; 8 (10%) crossed over to native tissue repair and 4 women (5%) withdrew from the study. Eighty (98%) of the women allocated to native tissue repair underwent the assigned treatment and 2 (2%) withdrew. Twenty-four months later, 140 surgically treated women (89%) demonstrated an overall anatomical success of 39%; 45% (32 out of 71 women) for mesh, and 32% (22 out of 69) for native tissue repair (RR 1.4, 95% CI 0.92 to 2.2). Composite success was 88 and 73% respectively (RR: 1.1, 95% CI 0.93 to 1.4). There was global improvement in 86% (48 out of 56 women) in the mesh group and in 77% (47 out of 60 women) in the native tissue group (RR: 1.1, 95% CI 0.92 to 1.3). Four women were diagnosed with mesh exposure at 2 years (6%).

          Conclusion

          At 24 months, no significant anatomical or composite benefit of partially absorbable mesh over native tissue repair could be demonstrated in women who had been surgically treated for primary POP.

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          Most cited references28

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          Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery.

          To estimate the lifetime risk of stress urinary incontinence (SUI) surgery, pelvic organ prolapse (POP) surgery, or both using current, population-based surgical rates from 2007 to 2011.
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            Lifetime risk of undergoing surgery for pelvic organ prolapse.

            To investigate the lifetime risk of first-time incident pelvic organ prolapse (POP) surgery with the intention of updating previous risk estimates that have been based on members of managed-care populations. Age-specific incidence rates of first-time prolapse surgery between 1981 and 2005 were calculated based on 44,728-incident cases. We estimated the lifetime risk as the cumulative incidence to age 85 years based on a life-table method and using the most recent cross-sectional incidence rates for the period 2001-2005. Age-standardized rates by calendar year were also calculated to show the secular trend in prolapse surgery. The lifetime risk of surgery for POP in the general female population was 19% based on the most recent cross-sectional rates, a figure higher than the 11-12% reported from U.S. managed-care populations. There is a relatively high likelihood that a woman in Western Australia will undergo surgery for POP during her lifetime. If, as our results suggest, the burden of genital prolapse in general populations is higher than previously thought, there is justification for a stronger evidence base for prevention, early detection and intervention to reduce the personal and societal costs of these gynecological conditions. II.
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              A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12).

              The aim of this study was to develop the short form of a condition-specific, reliable, validated and self-administered instrument to evaluate sexual function in women with pelvic organ prolapse and/or urinary incontinence. The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire -12 (PISQ-12) was developed from the data of 99 of 182 women surveyed to create the long form (PISQ-31). An additional 46 patients were recruited for further validation. All subsets regression analysis identified 12 items likely to predict PISQ-31 scores. Short form scores underwent correlation analysis with long form, Incontinence Impact Questionnaire - 7 (IIQ-7), Sexual History Form -12 (SHF-12) and Symptom Questionnaire (SQ) scores. Test-retest reliability was checked with a subset of 20 patients. All subsets regression analysis with R>0.92 identified 12 items that predicted PISQ-31 scores. Short form scores were highly correlated with long form scores ( R=0.75-0.95). Correlations of the PISQ-12 with SHF-12 ( R=-0.66 and -0.68) and IIQ-7 ( R=-0.38 and -0.54) scores were similar to correlation of the PISQ-31 with these other measures. Reliability was moderate to high, with weighted kappa values from 0.56 to 0.93. PISQ-12 scores were lower in patients with low sexual function as measured on the SHF-12 ( P <0.001), and lower in women with depression as measured on the SQ ( P <0.001). The PISQ-12 is a validated and reliable short form that evaluates sexual function in women with urinary incontinence and/or pelvic organ prolapse and predicts PISQ-31 scores. It is able to distinguish women with poor sexual function as measured on the SHF-12.
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                Author and article information

                Contributors
                +31-73-5533877 , Pieternelsteures@gmail.com
                Kirsten.Kluivers@radboudumc.nl
                Journal
                Int Urogynecol J
                Int Urogynecol J
                International Urogynecology Journal
                Springer International Publishing (Cham )
                0937-3462
                1433-3023
                29 August 2018
                29 August 2018
                2019
                : 30
                : 4
                : 565-573
                Affiliations
                [1 ]ISNI 0000 0004 0624 5690, GRID grid.415868.6, Department of Obstetrics and Gynaecology, , Reinier de Graaf Gasthuis, ; Delft, The Netherlands
                [2 ]ISNI 0000 0004 0501 9798, GRID grid.413508.b, Department of Obstetrics and Gynaecology, , Jeroen Bosch Ziekenhuis, ; Postbus 90153, 5200 ME Den Bosch, The Netherlands
                [3 ]ISNI 0000 0004 0444 9382, GRID grid.10417.33, Department of Obstetrics and Gynaecology, , Radboud University Medical Center, ; Nijmegen, The Netherlands
                [4 ]ISNI 0000000090126352, GRID grid.7692.a, Department of Obstetrics and Gynaecology, , University Medical Center Utrecht, ; Utrecht, The Netherlands
                Author information
                http://orcid.org/0000-0002-1702-8021
                Article
                3757
                10.1007/s00192-018-3757-5
                6450832
                30159720
                323ae39d-0e14-43da-bb90-324064e39385
                © The Author(s) 2018

                Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

                History
                : 22 April 2018
                : 31 July 2018
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100009933, Ethicon;
                Categories
                Original Article
                Custom metadata
                © The International Urogynecological Association 2019

                Obstetrics & Gynecology
                adverse events,anatomical success,composite outcome,native tissue repair,partially absorbable mesh,primary,pelvic organ prolapse

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