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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
MICHAEL VAINRIB, Meir Medical Center
ClinicalTrials.gov Identifier:
NCT02110680
First received: March 28, 2014
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Overactive Bladder
Device: Sports TENS 2
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Efficacy of Transcutaneous Nerve Stimulation on Improvement of Overactive Bladder Symptoms

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Change in day and night-time frequency of micturitions [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in a number of urgency and urge incontinence episodes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    change in OAB-q (overactive bladder questionnaire) score bladder diary: change in a number of urgency and urge incontinence episodes


Secondary Outcome Measures:
  • Change in quality of life in patients with overactive bladder syndrome at the end of TENS treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 40
Study Start Date: April 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TENS 1
TENS at posterior tibial nerve area
Device: Sports TENS 2
transcutaneous electric stimulation
Other Name: Sports TENS 2 by TensCare Ltd, United Kingdom.
Sham Comparator: TENS 2
TENS at shoulder area
Device: Sports TENS 2
transcutaneous electric stimulation
Other Name: Sports TENS 2 by TensCare Ltd, United Kingdom.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02110680

Contacts
Contact: Michael Vainrib, M.D. 972584705941 mvainrib@gmail.com

Locations
Israel
Meir Medical Center Not yet recruiting
Kfar Saba, Israel, 44410
Contact: Michael Vainrib, M.D.    972584705941    mvainrib@gmail.com   
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Michael Vainrib, M.D. Meir Medical Center
  More Information

No publications provided

Responsible Party: MICHAEL VAINRIB, M.D., Meir Medical Center
ClinicalTrials.gov Identifier: NCT02110680     History of Changes
Other Study ID Numbers: TENSOAB, TENSOAB
Study First Received: March 28, 2014
Last Updated: April 8, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Meir Medical Center:
overactive bladder
transcutaneous electric stimulation
posterior tibial nerve stimulation

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014