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)
View Full Details on ANZCTR
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ACTRN12605000329662
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