Efficacy of Transcutaneous Nerve Stimulation on Improvement of Overactive Bladder Symptoms

Overactive Bladder Clinical Trial

— TENSOAB  

Official title:

Efficacy of Transcutaneous Nerve Stimulation on Improvement of Overactive Bladder Symptoms

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02110680
• Other study ID #: TENSOAB
• Secondary ID: TENSOAB
• Status: Withdrawn
• Phase: Phase 2
• First received: March 28, 2014
• Last updated: March 14, 2016
• Start date: March 2016
• Est. completion date: December 2016

Study information

• Verified date: March 2016
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Device:
• Sports TENS 2
transcutaneous electric stimulation

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No