Electrical Nerve Stimulation for Overactive Bladder a Comparison of Treatments
Status unconfirmed · Not applicable
Conditions studied: Overactive Bladder, Urge Urinary Incontinence
In brief
The purpose of this study is to determine whether transcutaneous sacral nerve stimulation (TENS SNS) versus percutaneous tibial nerve stimulation (PTNS) is a more effective therapeutic option for subjects with idiopathic overactive bladder (OAB) who have failed conventional therapy. Our primary hypothesis is that TENS therapy is a more effective treatment option due to ease of use and improved subject compliance with this form of therapy.
Key facts
- Study ID
- NCT01940367
- Run by
- Walter Reed National Military Medical Center
- People needed
- 114
- Starts
- 2013-10-01
- Expected to finish
- 2017-12-01
- Last updated by the study team
- 2016-04-28
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female
- Age >18 years
- Predominant complaint urge urinary incontinence (3 or more episodes per week) OR overactive bladder (8 or more voids per day, and/or 2 or more voids per night)
- Failed trial of conservative therapy (bladder training, fluid modification, diet modification, caffeine restriction, pelvic floor training)
- Failed trial of anticholinergic either due to inability to take the medication, adverse reaction to medication, or no improvement on medication
- Willing and mentally competent to participate in study
- Willing to complete study questionnaires
- No contraindications to undergoing PTNS or TENS therapy
You may not qualify if…
- Age < 18 years
- Presence of urinary fistula
- Male. (Males will be excluded because of the different etiology of overactive bladder for males which is primarily caused by prostate problems for men versus the primarily idiopathic cause in women).
- Recurrent or current urinary tract infection (5 or more infections in the last 12 months)
- Bladder stones
- Bladder cancer or suspected bladder cancer
- Hematuria
- Pregnancy or planning to become pregnant during the study (urine pregnancy test will be administered to those who are premenopausal and who have not had a hysterectomy)
- Central or peripheral neurologic disorders such as Multiple Sclerosis, Parkinson's disease, spina bifida, or other spinal cord lesion
- Metal implants such as pacemaker, implantable defibrillator, or metal implants where PTNS or TENS device needs to be placed (sacrum or ankle/leg).
- Uncontrolled diabetes
- Diabetes with peripheral nerve involvement
- On anticoagulants
- Current use of anticholinergics or use within the last 4 weeks
- Current use of botox bladder injections or bladder botox injection within the last year
- Current use of interstim therapy or currently implanted interstim device or leads
- Bladder outlet obstruction
- Urinary retention or gastric retention
- Painful Bladder Syndrome/Interstitial Cystitis
Where it is running
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States
- Fort Belvoir Community Hospital — Fort Belvoir, Virginia, United States
- Portsmouth Naval Hospital — Portsmouth, Virginia, United States
Full record on ClinicalTrials.gov
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