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Neuromodulation

Sacral Neuromodulation for Overactive Bladder

N/A
Recruiting
Led By David Sheyn, MD
Research Sponsored by David Sheyn
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female
Diagnosis of urinary urge incontinence or overactive bladder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
Awards & highlights

Summary

This trial will compare two different ways of using sacral neuromodulation to treat overactive bladder, to see which one works better.

Who is the study for?
This trial is for English-speaking women aged 18 or older with a diagnosis of urinary urge incontinence or overactive bladder. Participants should have seen at least a 50% reduction in episodes after an initial SNM test and be willing to complete all study-related tasks.
What is being tested?
The study compares two ways of delivering sacral neuromodulation (SNM) for treating overactive bladder: one group will receive continuous SNM, while the other will get cyclic SNM. It's a multi-site trial where participants are randomly assigned to either method.
What are the potential side effects?
Potential side effects from SNM can include discomfort at the implant site, lead migration, technical problems with the device, infection risk, and possible changes in bowel function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am female.
Select...
I have been diagnosed with overactive bladder or urinary urge incontinence.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in ICIQ-OAB-QoL score
Change in Incontinence Impact Questionnaire SF (IIQ-7)
Change in OAB-q SF
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cyclic SNMExperimental Treatment1 Intervention
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to cycling stimulation program mode.
Group II: Continuous SNMActive Control1 Intervention
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to continuous stimulation programming (SNM is continuously stimulating without "off" periods)

Find a Location

Who is running the clinical trial?

Metro Health, MichiganOTHER
7 Previous Clinical Trials
3,596 Total Patients Enrolled
Northwestern UniversityOTHER
1,625 Previous Clinical Trials
937,239 Total Patients Enrolled
University of LouisvilleOTHER
342 Previous Clinical Trials
77,283 Total Patients Enrolled
~33 spots leftby Jun 2026
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