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Trial registered on ANZCTR


Registration number
ACTRN12613000099729
Ethics application status
Approved
Date submitted
31/12/2012
Date registered
25/01/2013
Date last updated
27/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Sacral nerve stimulation in treatment of fecal incontinence due to rectal hyposensitivity
Scientific title
Sacral nerve stimulation in treatment of adult patients with fecal incontinence due to rectal hyposensitivity
Secondary ID [1] 281709 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fecal incontinence 288007 0
Rectal hyposensitivity 288008 0
Condition category
Condition code
Surgery 288382 288382 0 0
Surgical techniques
Oral and Gastrointestinal 288417 288417 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with rectal hyposensitivity usually complain of fecal incontinence. Sacral nerve stimulation might help to increase the sensitivity of rectal mucosa, power of discrimination and continence. Sacral nerve stimulation will be done as a continuous stimulation . Temporary stimulation was performed with unilateral percutaneous nerve evaluation performed by insertion of a stimulating electrode (3065USC; Medtronic, Minneapolis, MN) into the S3 sacral foramen under local anesthesia and/or intravenous sedation. Default stimulation parameters were set at 210 microsecond pulse width, 15 Hz frequency, and a subsensory amplitude ranging between 0.5 and 10 V. Stimulation was done for 4 weeks followed by one week OFF. Successful percutaneous nerve evaluation (on basis of clinical improvement as judged by physician and patient) was followed by the offer of permanent stimulation.
Intervention code [1] 286247 0
Treatment: Surgery
Intervention code [2] 286272 0
Treatment: Devices
Comparator / control treatment
Randomized trial comparing intermittent (4 weeks stimulation for 24 hours daily followed by one week without stimulation followed by one week stimulatiob ) and continuous (4 weeks on) sacral nerve stimuation in treatment of fecal incontinence due to rectal hyposensitivity. Intermittent sacral nerve stimulation will be administered to participants in the comparator group.Temporary stimulation was performed with unilateral percutaneous nerve evaluation performed by insertion of a stimulating electrode (3065USC; Medtronic, Minneapolis, MN) into the S3 sacral foramen under local anesthesia and/or intravenous sedation. Default stimulation parameters were set at 210 microsecond pulse width, 15 Hz frequency, and a subsensory amplitude ranging between 0.5 and 10 V.
Control group
Active

Outcomes
Primary outcome [1] 288554 0
Discrimination of feces and flatus based on the patient diery without score
Timepoint [1] 288554 0
6 months
Primary outcome [2] 288555 0
Fecal continence using wexner continence score
Timepoint [2] 288555 0
12 months
Secondary outcome [1] 300454 0
defecatory desire volumes to rectal balloon distension. Baseline (PRE) and outcome evaluations included
the measurement of rectal sensation to balloon distension (secondary outcomes).
Timepoint [1] 300454 0
6 months
Secondary outcome [2] 300833 0
Impact on quality of life was assessed by validated disease-specific (GI)and Short Form-36 (SF-36) quality of life questionnaires.
Timepoint [2] 300833 0
6 months

Eligibility
Key inclusion criteria
Adult male or female
Fecal incontinence (wexner score < 12)
Rectal hyposensitivity (balloon volume to elicit first constant sensation (FCS), defecatory desire volume (DDV), and maximum tolerated volume(MTV). more than normal by 30% or more
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Injured anal sphincters
Injured pudendal nerve

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2013
Actual
1/02/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment outside Australia
Country [1] 4771 0
Egypt
State/province [1] 4771 0

Funding & Sponsors
Funding source category [1] 286503 0
Hospital
Name [1] 286503 0
Gamal Abd El Nasser Hospital
Country [1] 286503 0
Egypt
Primary sponsor type
Government body
Name
Health Insurance Institute
Address
Gamal Abd El Nasser Hospital, Alexandria, Egypt. 300 Horria avenue . Bab Sharki, 21321
Country
Egypt
Secondary sponsor category [1] 285289 0
Individual
Name [1] 285289 0
Khaled Madbouly-
Address [1] 285289 0
University Of alexandria, Department of Surgery. Azarita. 2 Shamplion avenue , 21322
Country [1] 285289 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288577 0
University of Alexandria
Ethics committee address [1] 288577 0
Ethics committee country [1] 288577 0
Egypt
Date submitted for ethics approval [1] 288577 0
01/11/2012
Approval date [1] 288577 0
01/12/2012
Ethics approval number [1] 288577 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36758 0
A/Prof Khaled Madbouly
Address 36758 0
University of alexandria- department of surgery- Azarita- 2 shamplion avenue, 21322
Country 36758 0
Egypt
Phone 36758 0
+2034802375
Fax 36758 0
+2034802375
Email 36758 0
khaled.madbouly@alexmed.edu.eg
Contact person for public queries
Name 36759 0
Khaled Madbouly
Address 36759 0
University of alexandria- department of surgery- Azarita, 2 shamplion avenue, 21322
Country 36759 0
Egypt
Phone 36759 0
+2034802375
Fax 36759 0
Email 36759 0
khaled.madbouly@alexmed.edu.eg
Contact person for scientific queries
Name 36760 0
Khaled Madbouly
Address 36760 0
University of alexandria- department of surgery- Azarita, 2 shamplion avenue, 21322
Country 36760 0
Egypt
Phone 36760 0
+2034802375
Fax 36760 0
Email 36760 0
khaled.madbouly@alexmed.edu.eg

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.