Electrical Nerve Stimulation for Overactive Bladder a Comparison of Treatments
Overactive Bladder, Urge Urinary Incontinence
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive Bladder, TENS, PTNS, Electrical Nerve Stimulation, Urge Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Walter Reed National Military Medical Center
- Fort Belvoir Community Hospital
- Portsmouth Naval Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
PTNS Arm
TENS Arm
Subjects randomized to the PTNS arm will undergo PTNS treatment once weekly for 30 minutes for 12 weeks total. If at 12 weeks they are considered to have a positive response to therapy, they will continue maintenance therapy in a tapered fashion: subjects will come in every 2 weeks for the next 8 weeks for 30 minute treatments (4 visits total), then every 3-4 weeks for 30 minute treatments for the remaining 32 weeks of the year (8-10 visits).
Subjects randomized to the TENS arm of the study will begin therapy after their baseline evaluation is complete. They will be issued a home TENS device (EMPI TENS Select) and will administer self-treatment daily for 2 hours per day (1 hour in the morning and 1 hour in the evening) for a total of 12 weeks. If they are considered to have a positive response with TENS treatment, subjects will continue by weaning use over a three-month time period. They will begin with 3 x per week for 1 month, then 2 x per week for 1 month, then 1 x per week for 1 month, all at 2 hours per day.