Evaluate Women After Vaginal Surgery for Urinary Symptoms and Sexual Function
Study of Sexual Function and Urinary Symptoms in Women Having Vaginal Surgeries
研究概览
详细说明
Currently, up to 43% of women in the United States have female sexual dysfunction (FSD). In a recent study of 109 sexually active women in a urogynecology practice, FSD was noted using the validated Female Sexual Function Index (FSFI) in 64% of the women. Difficulties with sexual function are also associated with pelvic organ prolapse and urinary incontinence. One in nine women will have surgery for incontinence or prolapse in her lifetime. The impact of vaginal surgeries on sexual function and urinary symptoms has been scarcely reported in the literature. The methodology of most of those studies is flawed by the use of questionnaires that were not validated, small sample sizes and no comparison control group. In addition, several studies only focused on one surgical intervention, specific types of incontinence or prolapse, or both. It is difficult to make sense out of the discordant research findings when applying it to our patient population.
This is a prospective study of women with incontinence or pelvic organ prolapse. Subjects will be selected from three urology practices. All patients will be asked to complete a short patient history form. If the woman meets the study criteria, the study will be explained and if she agrees to participate in this study, informed consent will be obtained. She will then complete the FSFI, SF-12 and PFDI-20 questionnaires.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Michigan
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Royal Oak、Michigan、美国、48073
- William Beaumont Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Women at least 18 years of age
- Having urinary incontinence or pelvic organ prolapse
- Capable of giving informed consent
- Capable and willing to follow all study related procedures
Exclusion Criteria:
- Reported history of urethral obstruction (not secondary to prolapse), stricture, bladder calculi or bladder tumor in the last 2 years.
- Pregnant as confirmed by urine pregnancy test or plans to become pregnant during the study period.
- Breast feeding
- Currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function
- Cannot independently comprehend and complete the questionnaires.
- The subject is deemed unsuitable for enrollment in this study by the investigators based on their history or physical examination.
学习计划
研究是如何设计的?
设计细节
合作者和调查者
调查人员
- 首席研究员:Kenneth Peters, M.D.、William Beaumont Hospitals
出版物和有用的链接
一般刊物
- Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA. 1999 Feb 10;281(6):537-44. doi: 10.1001/jama.281.6.537. Erratum In: JAMA 1999 Apr 7;281(13):1174.
- Norton P, Brubaker L. Urinary incontinence in women. Lancet. 2006 Jan 7;367(9504):57-67. doi: 10.1016/S0140-6736(06)67925-7.
- Pauls RN, Segal JL, Silva WA, Kleeman SD, Karram MM. Sexual function in patients presenting to a urogynecology practice. Int Urogynecol J Pelvic Floor Dysfunct. 2006 Nov;17(6):576-80. doi: 10.1007/s00192-006-0070-5. Epub 2006 Jun 8.
- Weber AM, Walters MD, Schover LR, Mitchinson A. Sexual function in women with uterovaginal prolapse and urinary incontinence. Obstet Gynecol. 1995 Apr;85(4):483-7. doi: 10.1016/0029-7844(94)00434-F.
- LeCroy C. Urinary incontinence occurring during intercourse: effect on sexual function in women. Urol Nurs. 2006 Feb;26(1):53-6. No abstract available.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Vaginal Surgery的临床试验
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International Partnership for Microbicides, Inc.完全的
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St. Joseph's Healthcare HamiltonHamilton Academic Health Sciences Organization完全的
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Seoul National University HospitalJohnson & Johnson Medical Companies完全的