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

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.

Study Overview

• Status: Withdrawn
• Conditions: Overactive Bladder
• Intervention / Treatment: Device: Sports TENS 2

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel, 44410
    • Meir Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TENS 1; TENS at posterior tibial nerve area	Device: Sports TENS 2; transcutaneous electric stimulation; Other Names: Sports TENS 2 by TensCare Ltd, United Kingdom.
Sham Comparator: TENS 2; TENS at shoulder area	Device: Sports TENS 2; transcutaneous electric stimulation; Other Names: Sports TENS 2 by TensCare Ltd, United Kingdom.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in day and night-time frequency of micturitions	change in OAB-q (overactive bladder questionnaire) score bladder diary: change in a frequency of micturitions during the day and night. change in a mean volume of micturitions.	12 weeks
Change in a number of urgency and urge incontinence episodes	change in OAB-q (overactive bladder questionnaire) score bladder diary: change in a number of urgency and urge incontinence episodes	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life in patients with overactive bladder syndrome at the end of TENS treatment	Filling of questionnaires: OAB-q (overactive bladder questionnaire), Patient perception of bladder condition (PPBC), Patient perception of global improvement (PPGI), Quality of life 5 dimensions (EQ5D)	12 weeks

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Investigators: Principal Investigator: Michael Vainrib, M.D., Meir Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: March 28, 2014
• First Submitted That Met QC Criteria: April 8, 2014
• First Posted (Estimate): April 10, 2014

Study Record Updates

• Last Update Posted (Estimate): March 16, 2016
• Last Update Submitted That Met QC Criteria: March 14, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: overactive bladder; posterior tibial nerve stimulation; transcutaneous electric stimulation
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: TENSOAB (Other Identifier: 0228-13MMC)