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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in ICIQ-OAB-QoL score

Secondary study objectives

Change in Incontinence Impact Questionnaire SF (IIQ-7)

Change in OAB-q SF

Change in Overactive Bladder Symptom Score (OABSS)

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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)

0 / 2Eligibility criteria met