Peripheral Electrical Stimulation for the Treatment of Overactive Bladder

Study Overview
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Brief Summary
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This clinical trial testing three different sites of transcutaneous electrical nerve stimulation for the treatment of overactive bladder (OAB).

Official Title
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Peripheral Electrical Stimulation for the Treatment of Overactive Bladder

Conditions
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Idiopathic Overactive Bladder

Intervention / Treatment
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* Procedure: Transcutaneous Electrical Nerve Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and Females, at least 18 years of age Documented symptoms of idiopathic overactive bladder for at least 3 months Failure on primary OAB treatment, such as behavior modification or fluid/diet management Patients can remain on stable medication Willing and capable of understanding and complying with all requirements of the protocol Signed Informed Consent to participate in the study after full discussion of the research nature of the treatment and its risks and benefits Exclusion Criteria: Urinary retention or post voiding residual greater than 100 ml Clinically significant bladder outlet obstruction Stress predominant mixed urinary incontinence Neurological disease affecting urinary bladder function, including but not limited to Parkinson's disease, multiple sclerosis, stroke, spinal cord injury. Pelvic surgery (such as sub-urethral sling, pelvic floor repair) within the past 6 months Denovo OAB following pelvic surgery sub-urethral sling Intravesical or urethral sphincter Botulinum Toxin Type A injections within the past 6 months Percutaneous Tibial Nerve Stimulation (PTNS) therapy for overactive bladder within the past 6 months Any form of electric stimulation to the pelvis or lower limbs within 4 weeks Vaginal prolapse greater than Stage II in the anterior compartment of the vagina using International Continence Society (ICS) Pelvic Organ ProlapseQuantification (POPQ) criteria. Prior periurethral or transurethral bulking agent injections for bladder problems within the past 12 months. History of pelvic radiation therapy Any skin conditions affecting treatment sites Lacking dexterity to properly utilize the components of the stimulator system. Presence of an implanted electro-medical device (e.g. pacemaker, defibrillator, InterStim®, etc.), Pregnant, nursing, suspected to be pregnant (by urine pregnancy method), or plans to become pregnant during the course of the study. Recurrent Urinary Tract Infections UTI (>3 UTI's in the past year) History of, or current, lower tract genitourinary malignancies Any clinically significant systemic disease or condition that in the opinion of the Investigator would make the patient unsuitable for the study Any other clinical trial within 6 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Unilateral Posterior Tibial Nerve Stimulation<br>Transcutaneous posterior tibial nerve stimulation applied 40 minutes every day for a duration of 4 weeks. The patient places the cathode electrode above, and the anode electrode behind, the medial malleolus, over the posterior tibial nerve and sets the stimulation intensity to a comfortable level. | Procedure: Transcutaneous Electrical Nerve Stimulation<br> <br> |
| Active Comparator: Bilateral Posterior Tibial Nerve Stimulation<br>Transcutaneous posterior tibial nerve stimulation applied 40 minutes every day for a duration of 4 weeks. The patient places the cathode electrode above, and the anode electrode behind, the medial malleolus, over the posterior tibial nerve on both legs and sets the stimulation intensity to a comfortable level. | Procedure: Transcutaneous Electrical Nerve Stimulation<br> <br> |
| Active Comparator: Shoulder stimulation<br>Stimulation applied 40 minutes every day for a duration of 4 weeks. The patient places the cathode and the anode electrodes on the lateral side of the left shoulder. | Procedure: Transcutaneous Electrical Nerve Stimulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in frequency of voiding | The change of urinary frequency from baseline to after 4 weeks of the treatment, measured by a 3 days bladder diary. | baseline, 4 weeks | 
| Change in Patient Perception of Bladder Condition (PPBC) | Change in the patient's bladder condition based on the PPBC questionaire from baseline to after 4 weeks of the treatment. | baseline, 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in symptom severity score and health-related quality of life score (HRQL) based on OAB-questionnaire | Change in symptom severity score and HRQL score from baseline to after 4weeks of the treatment. | baseline, 4 weeks | 
| Changes in the mental/physical scores of RAND36 |  | baseline, 4 weeks | 
| Change in urinary symptoms score and bother symptom score based on the ICIQ-OAB questionnaire | Change in urinary symptoms score and bother symptom score based on the ICIQ-OAB questionnaire from baseline to after 4 weeks of the treatment | baseline, 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overactive bladder, transcutaneous posterior tibial nerve stimulation, placebo PTNS