Peripheral Electrical Stimulation for the Treatment of Overactive Bladder

Overview

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

Registry

clinicaltrials.gov

Start Date

March 2013

End Date

March 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•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

•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.

Change in Patient Perception of Bladder Condition (PPBC)

Time Frame: baseline, 4 weeks

Change in the patient's bladder condition based on the PPBC questionaire from baseline to after 4 weeks of the treatment.

Change in frequency of voiding

Time Frame: baseline, 4 weeks

The change of urinary frequency from baseline to after 4 weeks of the treatment, measured by a 3 days bladder diary.

Change in urinary symptoms score and bother symptom score based on the ICIQ-OAB questionnaire(baseline, 4 weeks)
Changes in symptom severity score and health-related quality of life score (HRQL) based on OAB-questionnaire(baseline, 4 weeks)
Changes in the mental/physical scores of RAND36(baseline, 4 weeks)