Clinical trial NCT01940367: Electrical Nerve Stimulation for Overactive Bladder a Comparison of Treatments
Official title: Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overactive Bladder
Urge Urinary Incontinence
Keywords: Overactive Bladder
TENS
PTNS
Electrical Nerve Stimulation
Urge Urinary Incontinence
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
Collaborators: name: International Urogynecological Association
name: Section on Women's Health (Grant)
First posted: 2013-09-12
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: To compare the long-term efficacy, subject compliance, and subject satisfaction of percutaneous tibial nerve stimulation (PTNS) therapy versus transcutaneous electrical sacral nerve stimulation (TENS) for the treatment of subjects with idiopathic overactive bladder. Previous short-term studies suggest that these therapies have equal efficacy in improving OAB symptoms, but we hypothesize that long-term efficacy and success is actually higher in the TENS group due to ease of use, since subjects can self-administer this therapy. Secondary goals are to evaluate subject quality of life improvement scores, bladder diary scores (change in the frequency of urination), and changes in urodynamic studies while undergoing these therapies.

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

Primary outcomes:
measure: Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial
timeFrame: 2 years
Secondary outcomes:
measure: Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial
timeFrame: 2 years
measure: Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial
timeFrame: 2 Years
measure: Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial
timeFrame: 2 Years
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Fort Belvoir
country: United States
facility: Fort Belvoir Community Hospital
state: Virginia
city: Portsmouth
country: United States
facility: Portsmouth Naval Hospital
state: Virginia
Study officials:
affiliation: Walter Reed National Military Medical Center
name: Mary E McVearry, DPT, WCS
role: PRINCIPAL_INVESTIGATOR
References: