دورية أكاديمية
Effect of Pessary vs Surgery on Patient-Reported Improvement in Patients With Symptomatic Pelvic Organ Prolapse: A Randomized Clinical Trial.
| العنوان: | Effect of Pessary vs Surgery on Patient-Reported Improvement in Patients With Symptomatic Pelvic Organ Prolapse: A Randomized Clinical Trial. |
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| المؤلفون: | van der Vaart LR; Department of Obstetrics and Gynecology, Amsterdam Reproduction & Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands., Vollebregt A; Department of Obstetrics and Gynecology, Spaarne Gasthuis, Haarlem, the Netherlands., Milani AL; Department of Obstetrics and Gynecology, Reinier de Graaf Hospital, Delft, the Netherlands., Lagro-Janssen AL; Department of General Practice/Women's Studies Medicine, University Medical Centre Radboud, Nijmegen, the Netherlands., Duijnhoven RG; Department of Obstetrics and Gynecology, Amsterdam Reproduction & Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands., Roovers JWR; Department of Obstetrics and Gynecology, Amsterdam Reproduction & Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.; Department of Gynecology, Women's Health, Bergman Clinics, Amsterdam, the Netherlands., van der Vaart CH; Department of Gynecology, Women's Health, Bergman Clinics, Hilversum, the Netherlands.; Department of Obstetrics and Gynecology, UMCU, University of Utrecht, Utrecht, the Netherlands. |
| المصدر: | JAMA [JAMA] 2022 Dec 20; Vol. 328 (23), pp. 2312-2323. |
| نوع المنشور: | Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Medical Association Country of Publication: United States NLM ID: 7501160 Publication Model: Print Cited Medium: Internet ISSN: 1538-3598 (Electronic) Linking ISSN: 00987484 NLM ISO Abbreviation: JAMA Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Chicago : American Medical Association, 1960- |
| مواضيع طبية MeSH: | Pelvic Organ Prolapse*/etiology , Pelvic Organ Prolapse*/surgery , Pelvic Organ Prolapse*/therapy , Pessaries*/adverse effects , Gynecologic Surgical Procedures*/adverse effects , Gynecologic Surgical Procedures*/methods, Female ; Humans ; Middle Aged ; Netherlands ; Patient Reported Outcome Measures ; Quality of Life ; Treatment Outcome ; Aged |
| مستخلص: | Importance: Pelvic organ prolapse is a prevalent condition among women that negatively affects their quality of life. With increasing life expectancy, the global need for cost-effective care for women with pelvic organ prolapse will continue to increase. Objective: To investigate whether treatment with a pessary is noninferior to surgery among patients with symptomatic pelvic organ prolapse. Design, Setting, and Participants: The PEOPLE project was a noninferiority randomized clinical trial conducted in 21 participating hospitals in the Netherlands. A total of 1605 women with symptomatic stage 2 or greater pelvic organ prolapse were requested to participate between March 2015 through November 2019; 440 gave informed consent. Final 24-month follow-up ended at June 30, 2022. Interventions: Two hundred eighteen participants were randomized to receive pessary treatment and 222 to surgery. Main Outcomes and Measures: The primary outcome was subjective patient-reported improvement at 24 months, measured with the Patient Global Impression of Improvement scale, a 7-point Likert scale ranging from very much better to very much worse. This scale was dichotomized as successful, defined as much better or very much better, vs nonsuccessful treatment. The noninferiority margin was set at 10 percentage points risk difference. Data of crossover between therapies and adverse events were captured. Results: Among 440 patients who were randomized (mean [SD] age, 64.7 [9.29] years), 173 (79.3%) in the pessary group and 162 (73.3%) in the surgery group completed the trial at 24 months. In the population, analyzed as randomized, subjective improvement was reported by 132 of 173 (76.3%) in the pessary group vs 132 of 162 (81.5%) in the surgery group (risk difference, -6.1% [1-sided 95% CI, -12.7 to ∞]; P value for noninferiority, .16). The per-protocol analysis showed a similar result for subjective improvement with 52 of 74 (70.3%) in the pessary group vs 125 of 150 (83.3%) in the surgery group (risk difference, -13.1% [1-sided 95% CI, -23.0 to ∞]; P value for noninferiority, .69). Crossover from pessary to surgery occurred among 118 of 218 (54.1%) participants. The most common adverse event among pessary users was discomfort (42.7%) vs urinary tract infection (9%) following surgery. Conclusions and Relevance: Among patients with symptomatic pelvic organ prolapse, an initial strategy of pessary therapy, compared with surgery, did not meet criteria for noninferiority with regard to patient-reported improvement at 24 months. Interpretation is limited by loss to follow-up and the large amount of participant crossover from pessary therapy to surgery. Trial Registration: Netherlands Trial Register Identifier: NTR4883. |
| References: | Ultrasound Obstet Gynecol. 2019 Jan;53(1):124-128. (PMID: 29947126) Am J Obstet Gynecol. 2005 Jul;193(1):103-13. (PMID: 16021067) Neurourol Urodyn. 2015 Jan;34(1):24-31. (PMID: 24167010) Int Braz J Urol. 2020 Jan-Feb;46(1):5-14. (PMID: 31851453) Cochrane Database Syst Rev. 2020 Nov 18;11:CD004010. (PMID: 33207004) Am J Obstet Gynecol. 1996 Jul;175(1):10-7. (PMID: 8694033) Int Urogynecol J Pelvic Floor Dysfunct. 2009 Mar;20(3):349-56. (PMID: 19083135) Int Urogynecol J. 2010 May;21(5):523-8. (PMID: 20013110) Am J Obstet Gynecol. 2006 May;194(5):1492-8. (PMID: 16647933) Cochrane Database Syst Rev. 2016 Nov 30;11:CD004014. (PMID: 27901278) Int Urogynecol J. 2016 Dec;27(12):1797-1803. (PMID: 26992725) Am J Obstet Gynecol. 2003 Jul;189(1):98-101. (PMID: 12861145) Eur J Obstet Gynecol Reprod Biol. 2019 Mar;234:126-130. (PMID: 30685660) Lancet. 2007 Mar 24;369(9566):1027-38. (PMID: 17382829) Am J Obstet Gynecol. 2016 Nov;215(5):659.e1-659.e7. (PMID: 27319365) Int Urogynecol J. 2022 Feb;33(2):221-233. (PMID: 34982188) Int Urogynecol J. 2013 Jul;24(7):1091-103. (PMID: 23632798) Int Urogynecol J. 2017 Dec;28(12):1901-1907. (PMID: 28589290) J Sex Med. 2022 Feb;19(2):270-279. (PMID: 34969614) JAMA Netw Open. 2021 Sep 1;4(9):e2127792. (PMID: 34586365) JAMA. 2014 Mar 12;311(10):1023-34. (PMID: 24618964) Am J Obstet Gynecol. 2007 Apr;196(4):405.e1-8. (PMID: 17403437) Am J Obstet Gynecol. 2013 Nov;209(5):488.e1-5. (PMID: 23770473) Int Urogynecol J. 2023 Jan;34(1):53-65. (PMID: 35460345) Nephrology (Carlton). 2020 Jul;25(7):513-517. (PMID: 32147926) N Engl J Med. 2013 Sep 19;369(12):1124-33. (PMID: 24047061) Int Urogynecol J. 2022 Jul;33(7):1981-1987. (PMID: 34586439) Int Urogynecol J. 2011 Jun;22(6):637-44. (PMID: 21472447) Int Urogynecol J. 2019 Jan;30(1):107-114. (PMID: 30008079) JACC Heart Fail. 2022 Sep;10(9):651-661. (PMID: 35780032) Int Urogynecol J. 2013 May;24(5):707-18. (PMID: 23306770) Int Urogynecol J. 2018 Aug;29(8):1111-1116. (PMID: 29270721) Int Urogynecol J. 2018 Jan;29(1):99-107. (PMID: 28600758) Int Urogynecol J. 2014 Apr;25(4):531-44. (PMID: 24445668) J Pharmacol Pharmacother. 2010 Jul;1(2):100-7. (PMID: 21350618) BJOG. 2022 Apr;129(5):820-829. (PMID: 34559932) |
| تواريخ الأحداث: | Date Created: 20221220 Date Completed: 20221223 Latest Revision: 20230621 |
| رمز التحديث: | 20231215 |
| مُعرف محوري في PubMed: | PMC9857016 |
| DOI: | 10.1001/jama.2022.22385 |
| PMID: | 36538310 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1538-3598 |
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| DOI: | 10.1001/jama.2022.22385 |