The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
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
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)
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
Other design features
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
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
Primary sponsor type
Commercial sector/Industry
Medtronic Australasia
Secondary sponsor category [1] 448 0
Name [1] 448 0
Address [1] 448 0
Country [1] 448 0

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

Brief summary
Trial website
Trial related presentations / publications
Public notes

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
Phone 9337 0
+61 3 92215099
Fax 9337 0
+61 3 92215299
Email 9337 0
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
Phone 265 0
+61 3 93442000
Fax 265 0
Email 265 0

No information has been provided regarding IPD availability
Summary results
No Results