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


Eligibility

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

Plain Language Summary

Simplified for easier understanding

This study is comparing a small implanted device called a sacral nerve stimulator to conservative (non-surgical) treatments for people with severe bladder and bowel control problems. The stimulator is a small device placed near the tailbone that sends mild electrical signals to the nerves controlling the bladder and bowel. Researchers want to find out whether this device works better than other treatments for people whose symptoms have not improved with standard care. You may be eligible if: - You are between 18 and 80 years old - You have severe and treatment-resistant overactive bladder (including urge incontinence or urgency-frequency syndrome), urinary retention, or neuropathic faecal incontinence - You are willing to take part You may NOT be eligible if: - You are not fit for surgery - You have a major neurological disease or an infection risk that contraindicates the device - You have stress urinary incontinence as your main symptom - You have bladder outlet obstruction - You have a fixable anal sphincter defect or rectal prolapse - You do not wish to take part Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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


Locations(1)

Australia

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ACTRN12605000329662


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