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Trial registered on ANZCTR


Registration number
ACTRN12605000329662
Ethics application status
Approved
Date submitted
9/08/2005
Date registered
7/09/2005
Date last updated
15/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial comparing the implanted sacral nerve stimulator device with conservative treatment for severe and refractory lower urinary tract symptoms and faecal incontinence.
Scientific title
A randomised controlled trial comparing the implanted sacral nerve stimulator device with conservative treatment for severe and refractory lower urinary tract symptoms and faecal incontinence.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urge incontinence 417 0
Frequency-urgency syndrome 418 0
Voiding dysfunction, 419 0
Neuropathic faecal incontinence 420 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study group will undergo implantation by two stages of the sacral neuromodulation (SNS) device.
Intervention code [1] 148 0
Treatment: Devices
Comparator / control treatment
The control group will continue to undergo conservative management only. The control group will receive the SNS after 6 months and continue observation for another 6 months as the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 559 0
Cure of symptoms determined by bladder or bowel diary
Timepoint [1] 559 0
Secondary outcome [1] 1188 0
1. Visual Analogue Score (VAS) for patient satisfaction
Timepoint [1] 1188 0
At 3, 6 and 12 months.
Secondary outcome [2] 1189 0
2. Validated quality of life questionnaires (SF-36, IIQ-7, UDI-6, quality of life scale for fecal incontinence, Cleveland clinic continence score, HADS).
Timepoint [2] 1189 0
At 6 and 12 months.
Secondary outcome [3] 1190 0
3. Complications will be recorded.
Timepoint [3] 1190 0
Secondary outcome [4] 1191 0
4. Costs for the SNS device and supportive therapy.
Timepoint [4] 1191 0

Eligibility
Key inclusion criteria
*Patients with severe and refractory over active bladder syndromes (urge incontinence, urgency-frequency syndrome) and idiopathic urinary retention. *Patients with concomitant urinary and anorectal symptoms may be included.*Patients with concomitant urinary symptoms and chronic pelvic or perineal pain syndromes may be included.*Patients with severe and refractory neuropathic faecal incontinence.*Willingness to participate.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Medically unfit for surgery*Contraindication/relative indications - risk of infection (e.g. women with artificial heart valves), major neurological disease.*Patients with symptomatic stress urinary incontinence.*Patients with bladder outlet obstruction.*Patients with an anal sphincter defect or rectal prolapse amenable to conventional surgical treatment.*Refusal to participate.

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)
Envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The computer software used was Minitab,a statistical software program.Initially 14 random allocations for RMH and 14 for Frances Perry. These were done separately, but guaranteeing equal sample sizes in the two groups, at each site (7 and 7). Subsequently another 12 for Frances Perry, and I used the same software and the same approach, so that among the 12 there were guaranteed to be 6 in each group
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 554 0
Commercial sector/Industry
Name [1] 554 0
Medtronic Australasia
Address [1] 554 0
Country [1] 554 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Australasia
Address
Country
Australia
Secondary sponsor category [1] 448 0
None
Name [1] 448 0
n/a
Address [1] 448 0
Country [1] 448 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1577 0
Royal Women's Hospital, Human Ethics Committee
Ethics committee address [1] 1577 0
Melbourne
Ethics committee country [1] 1577 0
Australia
Date submitted for ethics approval [1] 1577 0
Approval date [1] 1577 0
Ethics approval number [1] 1577 0

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

Contacts
Principal investigator
Name 35868 0
Address 35868 0
Country 35868 0
Phone 35868 0
Fax 35868 0
Email 35868 0
Contact person for public queries
Name 9337 0
Dr Marcus Carey
Address 9337 0
Frances Perry House
Suite D Level 10
Cardigan St
Carlton VIC 3053
Country 9337 0
Australia
Phone 9337 0
+61 3 92215099
Fax 9337 0
+61 3 92215299
Email 9337 0
mcarey@affinityhealth.com.au
Contact person for scientific queries
Name 265 0
Dr Peta Higgs
Address 265 0
Urogynaecology Department
Royal Women's Hospital
Grattan St
Carlton VIC 3053
Country 265 0
Australia
Phone 265 0
+61 3 93442000
Fax 265 0
Email 265 0
peta_higgs@hotmail.com

No data has been provided for results reporting
Summary results
Not applicable