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临床试验/NCT01525485
NCT01525485已完成不适用

Vaginal Electrical Stimulation Versus Sacral Neuromodulation for the Treatment of Refractory Overactive Bladder: A Pilot Study

University of Oklahoma1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Symptom improvement

研究概览

简要总结

This prospective study compares quality of life measures of patients with refractory overactive bladder, between two modes of neuromodulation: vaginal electrical stimulation (Group A) and sacral nerve stimulation (Group B).

The specific aims are:

  1. To characterize patient symptom bother score, quality of life, and body image scores in patients obtaining sacral nerve stimulation, as compared to vaginal electrical stimulation.
  • Hypothesis 1: Both modes of neuromodulation will impact patients' scores in quality of life, patient symptoms, and body image questionnaires.

详细描述

All participants will have a standardized intake history which will include age, weight, history of prior treatment for incontinence, medication list, obstetric and gynecologic history, medical history, and surgical history, as well as a complete review of systems. The physical examination will include vital signs (including BMI), genitourinary exam, including Pelvic Organ Prolapse Quantification (POPQ), and neurologic exam. All patients will undergo spontaneous uroflowmetry, urine dipstick from catheterized specimen, multichannel urodynamics, and 3-day voiding diary. Measurement of post-void residual will also be obtained. Completion of the UDI-69, King's Health Questionnaire10, and the Modified Body Image Perception Scale (MBIS) will also be part of the initial visit 11,12.

All participants taking anticholinergics will undergo a 2 week flush-out period prior to the intake assessment. After the intake assessment, the provider will determine which treatment option is appropriate to the participant, and they will then be assigned to one of the two treatment arms: Group A will use vaginal electrical stimulation using the Empi Intravaginal Stimulation Unit Minnova (Empi, St. Paul, MN, USA) and participants in Group B will receive sacral neuromodulation using InterStim (Medtronic, Minneapolis, MN, USA).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
21 Years 至 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosis of refractory OAB (+/- UUI)*
  • Female Gender
  • Eligible for both treatment interventions
  • Available for 8 weeks of follow-up
  • Able to complete study assessments
  • Must discontinue anticholinergics within 2 weeks of intervention

排除标准

  • Age < 21
  • Pregnancy
  • Stage 3 or 4 pelvic organ prolapse
  • Current use of anticholinergics
  • Urinary tract infection
  • Undergoing concurrent treatment for pelvic organ prolapse
  • Unstable or serious cardiac arrhythmia
  • Implanted pacemaker
  • Postvoid residual > 100ml
  • Unstable seizure disorder
  • Dementia or inability to follow instructions

结局指标

主要结局

Symptom improvement

时间窗: 3 months

\>50% improvement in symptoms and decrease in frequency of voids and episodes of nocturia. Subjective outcomes will be measured by improvement in scores on the UDI-6, KHG, and MBIS.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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