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.
- Conditions
- rge incontinenceFrequency-urgency syndromeVoiding dysfunction,Neuropathic faecal incontinenceUrge incontinence
- Registration Number
- ACTRN12605000329662
- Lead Sponsor
- Medtronic Australasia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
*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.
*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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cure of symptoms determined by bladder or bowel diary[]
- Secondary Outcome Measures
Name Time Method 1. Visual Analogue Score (VAS) for patient satisfaction[At 3, 6 and 12 months.];2. Validated quality of life questionnaires (SF-36, IIQ-7, UDI-6, quality of life scale for fecal incontinence, Cleveland clinic continence score, HADS).[At 6 and 12 months.];3. Complications will be recorded.[];4. Costs for the SNS device and supportive therapy.[]