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临床试验/NCT03500146
NCT03500146已完成不适用

Sexual Function Trial of Overactive Bladder: Medication Versus PTNS

Medstar Health Research Institute5 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2017年1月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
175
试验地点
5
主要终点
overall FSFI

研究概览

简要总结

Sexual dysfunction affects approximately 45% of women with an even greater incidence reported in women with overactive bladder symptoms, despite this there is a lack of FDA approved treatments for sexual dysfunction in this population. While both medical therapy and electrical neuromodulation have been shown to improve urinary function as well as sexual function, there is a dearth of literature about their comparative effectiveness in the latter. The purpose of this study is to examine the comparative effectiveness of neuromodulation via percutaneous tibial nerve stimulation (PTNS) and medical therapy with anticholinergics or beta-agonists in improving female sexual function. This will be a prospective multi-center cohort study comparing improvement in sexual function as measured by the female sexual function index (FSFI). It is hypothesized that PTNS will improve sexual function to a greater degree than medical therapy as there may be mechanisms by which PTNS directly affects sexual function. Enhanced understanding of the effects of neuromodulation and medical therapy on sexual function may allow for improved patient selection and better outcomes which may lead to widespread use of neuromodulation for female sexual dysfunction.

详细描述

Specific aims:

Primary aim:

Aim 1: To determine if there is greater improvement in female sexual function as measured by the female sexual function index (FSFI) with percutaneous tibial nerve stimulation (PTNS) as compared to medical therapy (MT).

Hypothesis: There will be a greater improvement in overall FSFI with PTNS as compared to MT.

Secondary aims:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients greater than 18 years of age
  • Symptomatology of urinary urgency or urge incontinence planning to undergo MT or PTNS. Patients must meet a threshold bother defined by a positive response and bother of "somewhat, quite a bit, a great deal, or a very great deal" to questions #2, #3 or #8 on the OAB-q regarding urinary urgency and urgency incontinence.
  • Patients may have tried other medication for overactive bladder in the past but should be off therapy for at least one month
  • Patients must be currently sexually active with sexual activity within the past month and plans to continue for the duration of the study. Sexual activity, as defined in the FSFI questionnaire, may include caressing, foreplay, masturbation, and vaginal intercourse.

排除标准

  • Contraindications to PTNS (skin, orthopedic or anatomical limitation that could prevent placement of PTNS electrode, presence of pacemaker)
  • Contraindications to both anticholinergic and beta agonist therapy
  • Current symptomatic UTI within past week
  • Pregnant or planning to become pregnant
  • Prior treatment with SNM, PTNS, onobotulinum toxin A or two medications (stopped for reasons unrelated to side effects)
  • Diagnosed or suspected interstitial cystitis/painful bladder syndrome
  • Diagnosis of neurogenic bladder
  • Prolapse greater than Stage 2, pessary use or planned surgery for pelvic floor disorder during the study
  • Planned simultaneous treatment with both PTNS and MT

研究组 & 干预措施

Normal sexual function

Patients with an overall FSFI score equal to or above 26.5 will be in the normal sexual function group. Patients in both groups will be treated with an overactive bladder treatment, either anticholinergics, beta-agonists or PTNS.

干预措施: Anticholinergic (Drug)

Normal sexual function

Patients with an overall FSFI score equal to or above 26.5 will be in the normal sexual function group. Patients in both groups will be treated with an overactive bladder treatment, either anticholinergics, beta-agonists or PTNS.

干预措施: PTNS (Procedure)

Low sexual function

Female sexual dysfunction is defined as an overall FSFI score below 26.5, patients meeting this criteria will be in the low sexual function group. Patients in both groups will be treated with an overactive bladder treatment, either anticholinergics, beta-agonists or PTNS.

干预措施: Anticholinergic (Drug)

Low sexual function

Female sexual dysfunction is defined as an overall FSFI score below 26.5, patients meeting this criteria will be in the low sexual function group. Patients in both groups will be treated with an overactive bladder treatment, either anticholinergics, beta-agonists or PTNS.

干预措施: PTNS (Procedure)

结局指标

主要结局

overall FSFI

时间窗: After 12 weeks

Continuous variable

次要结局

未报告次要终点

研究者

发起方
Medstar Health Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (5)

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