Efficacy of Transcutaneous Nerve Stimulation on Improveme... | NCT02110680

Studies
Efficacy of Transcutaneous Nerve Stimulation on Improvement of Overactive Bladder Symptoms

NCT02110680

Sponsor

Meir Medical Center

Status

Withdrawn

Last Update Posted

Mar 16, 2016Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Overactive Bladder

Interventions

Sports TENS 2

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
TENSOAB	Other Identifier	0228-13MMC

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Mar 28, 2014

First Submission Date that Met QC Criteria

Apr 8, 2014

First Posted Date

Apr 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2016

Last Update Posted Date

Mar 16, 2016Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Sports TENS 2	Device	transcutaneous electric stimulation	TENS 1 TENS 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications