Efficacy of Transcutaneous Nerve Stimulation on Improvement of Overactive Bladder Symptoms

Phase 2

Withdrawn

• Conditions: Overactive Bladder
• Interventions: Device: Sports TENS 2

• Registration Number: NCT02110680
• Lead Sponsor: Meir Medical Center

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-03-28
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-10
• Status Verified: 2016-03
• Study Start: 2016-03
• Last Update Submitted: 2016-03-14
• Last Update Posted: 2016-03-16
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
TENS 2	Sports TENS 2	TENS at shoulder area
TENS 1	Sports TENS 2	TENS at posterior tibial nerve area

Primary Outcome Measures

Name	Time	Method
Change in a number of urgency and urge incontinence episodes	12 weeks	change in OAB-q (overactive bladder questionnaire) score bladder diary: change in a number of urgency and urge incontinence episodes
Change in day and night-time frequency of micturitions	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in quality of life in patients with overactive bladder syndrome at the end of TENS treatment	12 weeks	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)

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel