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Trial registered on ANZCTR


Registration number
ACTRN12611000445976
Ethics application status
Not yet submitted
Date submitted
21/04/2011
Date registered
2/05/2011
Date last updated
2/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of transcutaneous electrical nerve stimulation for treating patients with refractory overactive bladder syndrome
Scientific title
Effect of transcutaneous electrical nerve stimulation for treating patients with refractory overactive bladder syndrome evaluated by bladder diary and patient satisfaction assessment
Secondary ID [1] 260050 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overactive bladder syndrome 265712 0
Condition category
Condition code
Renal and Urogenital 265852 265852 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transcutaneous electrical nerve stimulation (TENS) for treating patients with refractory overactive bladder syndrome is performed with an Elpha 4 Conti stimulation device applying vaginal electrodes in women and circular penile electrodes in men, the treatment period is 12 weeks stimulating for 20 minutes twice a day (once in the morning, once in the evening).
Intervention code [1] 264468 0
Treatment: Devices
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266614 0
bladder diary (number of voids per 24 hours, voided volume in mL, number of pads used per 24 hours)
Timepoint [1] 266614 0
before treatment, after 12 weeks of TENS treatment, at 1 year after TENS treatment or if not available at the date of the last known follow-up after TENS treatment
Primary outcome [2] 266615 0
patient satisfaction assessment (using a questionnaire with a 5 point Likert scale)
Timepoint [2] 266615 0
before treatment, after 12 weeks of TENS treatment, at 1 year after TENS treatment or if not available at the date of the last known follow-up after TENS treatment
Secondary outcome [1] 276098 0
adverse events (i.e. general adverse events assessed by questionnaire and categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events, and especially pain, cutaneous irritation, or infection due to TENS treatment)
Timepoint [1] 276098 0
before treatment, after 12 weeks of TENS treatment, at 1 year after TENS treatment or if not available at the date of the last known follow-up after TENS treatment

Eligibility
Key inclusion criteria
OAB with urodynamically proven detrusor overactivity, failed behavioural treatment and pharmacotherapy with at least 2 antimuscarinics for a minimum of 1 month, and no previous surgery for OAB
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
pregancy, age <18 years, not fulfilling inclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3420 0
Switzerland
State/province [1] 3420 0
Bern

Funding & Sponsors
Funding source category [1] 264944 0
Self funded/Unfunded
Name [1] 264944 0
Address [1] 264944 0
Country [1] 264944 0
Primary sponsor type
Hospital
Name
Department of Urology
Address
Department of Urology
Inselspital
University of Bern
3010 Bern
Country
Switzerland
Secondary sponsor category [1] 264041 0
None
Name [1] 264041 0
Address [1] 264041 0
Country [1] 264041 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266903 0
Ethics committee address [1] 266903 0
Ethics committee country [1] 266903 0
Date submitted for ethics approval [1] 266903 0
01/12/2003
Approval date [1] 266903 0
Ethics approval number [1] 266903 0
This study has not been judged by an official ethics committee, which has a HREC Number. At this time, the study was discussed, ethically judged, and eventually approved by the staff of the Department of Urology, University of Bern. The study has been conducted according to the Declaration of Helsinki.

Summary
Brief summary
Overactive bladder syndrome (OAB) is highly prevalent and affects the lives of millions of people worldwide. Although antimuscarinics are the pharmacological treatment of choice for OAB, the effectiveness is limited. Thus, there is an urgent need for effective, well-tolerated therapeutic alternatives. Transcutaneous electrical nerve stimulation (TENS) is an established treatment for OAB in children and may also be a valuable option in adults. We therefore aimed to investigate the effect of TENS for treating adult patients with refractory OAB.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 32528 0
Address 32528 0
Country 32528 0
Phone 32528 0
Fax 32528 0
Email 32528 0
Contact person for public queries
Name 15775 0
Thomas M. Kessler
Address 15775 0
Department of Urology
Inselspital
University of Bern
3010 Bern
Country 15775 0
Switzerland
Phone 15775 0
+41 31 632 20 45
Fax 15775 0
Email 15775 0
tkessler@gmx.ch
Contact person for scientific queries
Name 6703 0
Thomas M. Kessler
Address 6703 0
Department of Urology
Inselspital
University of Bern
3010 Bern
Country 6703 0
Phone 6703 0
+41 31 632 20 45
Fax 6703 0
Email 6703 0
tkessler@gmx.ch

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary