RecruitingACTRN12605000329662

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.

Sponsor

Medtronic Australasia

Enrollment

60 participants

Start Date

Apr 4, 2004

Study Type

Interventional

Conditions

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

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.

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