Efficacy of Transcutaneous Nerve Stimulation on Improvement of Overactive Bladder Symptoms

NCT02110680 | Withdrawn Phase 2

• 1 other identifier: TENSOAB
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder

Keywords

overactive bladder; transcutaneous electric stimulation; posterior tibial nerve stimulation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in quality of life in patients with overactive bladder syndrome at the end of TENS treatment

  12 weeks

Study Arms (2)

TENS 1

ACTIVE COMPARATOR

TENS at posterior tibial nerve area

Device: Sports TENS 2

TENS 2

SHAM COMPARATOR

TENS at shoulder area

Device: Sports TENS 2

Interventions

Sports TENS 2 DEVICE

transcutaneous electric stimulation

Also known as: Sports TENS 2 by TensCare Ltd, United Kingdom.

TENS 1; TENS 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, 44410, Israel

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Vainrib, M.D.

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 10, 2014
• Study Start: March 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

IL (1)