Efficacy of Transcutaneous Nerve Stimulation on Improvement of Overactive Bladder Symptoms (TENSOAB)

Clalit Health Services

Status and phase

Withdrawn

Phase 2

Conditions

Overactive Bladder

Treatments

Device: Sports TENS 2

Study type

Interventional

Funder types

Other

Identifiers

NCT02110680

TENSOAB (Other Identifier)

Details and patient eligibility

About

Overactive bladder (OAB) is a very common problem that impairs the quality of life of about 17% of adult population in USA above the age of 40. The issues becomes more prominent with getting older. OAB was determined by International Continence Society as urgency (immediate desire to urinate that could not be postponed) with or without incontinence usually associated with increased frequency and nocturia (urination at night). In 2012, American Urologic Association published clinical guidelines for the treatment of OAB of non neurogenic origin. Neuromodulation was proposed as the third line of treatment and two treatments were recommended: sacral nerve neuromodulation (SNM) and posterior tibial nerve stimulation (PTNS). Each of above mentioned procedures are invasive. SNM involves lead implantation in operating room using X-ray guidance and anesthesia. PTNS involves needle insertion on the low extremity.

The investigators would like to examine the efficacy of transcutaneous nerve stimulation (TENS) in refractory to the first two lines of OAB treatment patients.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

male and female patients
age above 18
OAB symptoms more than 6 months before run into the study
OAB symptoms refractory to medical oral and cognitive treatments
Adverse events or unwillingness to continue with abovementioned treatments
patients with OAB symptoms with no evidence of neuropathic nature
patients who signed informed consent fully understanding the treatment and study design

Exclusion criteria

children
patients who unable or did not sign an informed consent or do not understand the study design and the treatment
patients who have implanted electric devices (eg. cardiac stimulators etc.)
patients who have post voiding residual more than 100ml
patients who have neuropathic OAB or pelvic ongoing malignancy or prior pelvic radiation
patients who were treated in the last 6 months with SNM, PTNS or intravesical Botox injections
patients with denovo OAB after recent implantation of tension-free vaginal tape (TVT) procedure
stress urinary incontinence predominant complaints in mixed incontinence patients
significant pelvic organ prolapse in women or an evidence of significant bladder outlet obstruction in male patients
patients with a history of recurrent urinary tract infections (UTIs) during the last 2 years
any medical condition that involves skin on the lower extremity
bilateral leg amputation
any medical condition that on investigator's mind could have an adverse impact on the patient during the study
participation in a clinical study at the last 6 months