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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000329662

Enrollment

Registered

2005-09-07

Start date

2004-04-04

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

The study group will undergo implantation by two stages of the sacral neuromodulation (SNS) device.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

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.

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.

Outcome results