Vaginal Electrical Stimulation Versus Neuromodulation

Completed

Conditions studied: Refractory Overactive Bladder

In brief

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.

Key facts

Study ID

NCT01525485

Run by

University of Oklahoma

People needed

34

Starts

2011-03-01

Expected to finish

2016-04-01

Last updated by the study team

2016-06-09

Who can join

Age: 21 and older, up to 99. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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