search
Back to results

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

Primary Purpose

Overactive Bladder

Status
Withdrawn
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Sports TENS 2
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring overactive bladder, transcutaneous electric stimulation, posterior tibial nerve stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Meir Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

TENS 1

TENS 2

Arm Description

TENS at posterior tibial nerve area

TENS at shoulder area

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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)

Full Information

First Posted
March 28, 2014
Last Updated
March 14, 2016
Sponsor
Meir Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02110680
Brief Title
Efficacy of Transcutaneous Nerve Stimulation on Improvement of Overactive Bladder Symptoms
Acronym
TENSOAB
Official Title
Efficacy of Transcutaneous Nerve Stimulation on Improvement of Overactive Bladder Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Withdrawn
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
overactive bladder, transcutaneous electric stimulation, posterior tibial nerve stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TENS 1
Arm Type
Active Comparator
Arm Description
TENS at posterior tibial nerve area
Arm Title
TENS 2
Arm Type
Sham Comparator
Arm Description
TENS at shoulder area
Intervention Type
Device
Intervention Name(s)
Sports TENS 2
Other Intervention Name(s)
Sports TENS 2 by TensCare Ltd, United Kingdom.
Intervention Description
transcutaneous electric stimulation
Primary Outcome Measure Information:
Title
Change in day and night-time frequency of micturitions
Description
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.
Time Frame
12 weeks
Title
Change in a number of urgency and urge incontinence episodes
Description
change in OAB-q (overactive bladder questionnaire) score bladder diary: change in a number of urgency and urge incontinence episodes
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in quality of life in patients with overactive bladder syndrome at the end of TENS treatment
Description
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)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Vainrib, M.D.
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
44410
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Transcutaneous Nerve Stimulation on Improvement of Overactive Bladder Symptoms

We'll reach out to this number within 24 hrs