Electrical Nerve Stimulation for Overactive Bladder a Comparison of Treatments
|ClinicalTrials.gov Identifier: NCT01940367|
Recruitment Status : Unknown
Verified April 2016 by Shannon Lamb, Walter Reed National Military Medical Center.
Recruitment status was: Enrolling by invitation
First Posted : September 12, 2013
Last Update Posted : April 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder Urge Urinary Incontinence||Device: PTNS (Percutaneous Tibial Nerve Stimulation Device: TENS (Transcutaneous Electrical Nerve Stimulation)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||December 2017|
Active Comparator: PTNS 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).
Device: PTNS (Percutaneous Tibial Nerve Stimulation
PTNS therapy is performed as follows; the subject sits in a frog leg position in a chair. The area where the needle will be placed is cleaned with an alcohol swab. A 34 gauge needle (equivalent to an acupuncture needle) is inserted percutaneously approximately 5 cm cephalad to the medial malleolus of the right or left ankle (subject choice) at a 60 degree angle. A surface electrode is placed on the medial aspect of the ipsilateral calcaneous. The needle and electrode are connected to a low voltage (9 V) electrical stimulator (Urgent PC). Stimulation current with a fixed frequency of 20 Hz and a pulse width of 200 msec is increased until flexion of the big toe or fanning of all toes becomes visible, or until the subject reports a tingling sensation across the heel or bottom of the foot. The current is then set to the highest level tolerable to the subject (0-10 mA) and the subject undergoes therapy for 30 minutes.
Other Name: Urgent ® PC Neuromodulation System
Active Comparator: TENS Arm
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.
Device: TENS (Transcutaneous Electrical Nerve Stimulation)
TENS therapy will be administered as follows:
Other Name: EMPI TENS Select
- Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial [ Time Frame: 2 years ]The primary response variable is 'success' at 1 year, defined as a 50% or more reduction in the total number of incontinence episodes, or a 25% or more reduction in number of daily or nightly voids AND that the patient continues to use the therapy at one year. Therefore primary response is: 50% reduction in incontinence, OR 25% reduction in nightly voids AND continued use of therapy at one year.
- Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial [ Time Frame: 2 years ]Participant compliance defined as 75% adherence to the recommended use for each device.
- Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial [ Time Frame: 2 Years ]Changes in the OAB-q (Overactive Bladder Questionnaire), the PFDI (Pelvic Floor Distress Inventory), and the FSFI (Female Sexual Function Index)
- Percutaneous Tibial Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Overactive Bladder: A Randomized Trial [ Time Frame: 2 Years ]Changes in urodynamic studies (i.e. bladder capacity, uroflow rate, post-void residual).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01940367
|United States, Maryland|
|Walter Reed National Military Medical Center|
|Bethesda, Maryland, United States, 20889|
|United States, Virginia|
|Fort Belvoir Community Hospital|
|Fort Belvoir, Virginia, United States, 22060|
|Portsmouth Naval Hospital|
|Portsmouth, Virginia, United States, 23708|
|Principal Investigator:||Mary E McVearry, DPT, WCS||Walter Reed National Military Medical Center|