OHSU

Refractory Overactive Bladder: Sacral Neuromodulation v. Botulinum Toxin Assessment

Clinical Trial Seeking Participants

IRB 8190 (PI: W. Thomas Gregory, MD)

The Women’s Health Research Unit is conducting a study comparing the success rates of different procedures for treating urge urinary incontinence.

Trial status

Open Enrollment

Why is this study being done?

Some women who suffer from urge urinary incontinence (leakage of urine with a sudden strong sense of urgency to urinate) have tried multiple types of treatments without significant improvements. The next step in treatment is often surgery. The Interstim® neuromdulation system is currently FDA approved for the treatment of urge incontinence. Currently, BOTOX is approved only for people with neurogenic bladder, that is, people who are incontinent but also have a neurological condition such as spinal cord injury or multiple sclerosis.

Researchers hope to determine if BOTOX® injections into the bladder wall are a viable alternative to InterStim® in women with non-neurogenic bladder.

Who is eligible to participate?

This study is currently only recruiting new subjects from Urogynecology practices from the Portland area.

What is the compensation for this study?

Up to $500 compensation for time and travel which requires:

  • 1 baseline visit, approximately 4 hours
  • Procedure visit(s)-varies
  • 6 visits to OHSU over 24 months, approximately 1 hour each
  • Up to7 telephone follow-up calls over 24 months, approximately 1 hour each

Who do I contact for additional information?

To find out more information and to learn if you are qualified to participate call the Women’s Health Research Unit confidential recruitment line: 503-494-3666