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Procedure

Sacral Neuromodulation for Urge Incontinence

N/A

Recruiting

Led By Kimberly Kenton, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Non-pregnant women >/=18 years old undergoing sacral neuromodulation (SNM) treatment for urgency urinary incontinence (UUI) or urgency-frequency (UF) who have elected to undergo testing phase with a PNE

Be older than 18 years old

Must not have

>/= Stage III pelvic organ or vaginal vault prolapse and/or current pessary use

Neurological diseases such as multiple sclerosis, clinically significant peripheral neuropathy, or complete spinal cord injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 or 7 days depending on treatment arm

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a shorter version of a test called percutaneous nerve evaluation (PNE) for a treatment called sacral neuromodulation (SNM) for urgency incontinence.

Who is the study for?

This trial is for individuals with overactive bladder and urge urinary incontinence who haven't had relief from other treatments. Participants should be candidates for sacral neuromodulation, a device-based therapy. The study excludes those who don't meet the specific medical criteria set by the researchers.

What is being tested?

The trial tests whether a shorter, 3-day evaluation period using percutaneous nerve evaluation (PNE) before full implantation of a sacral neuromodulation device is as effective as the traditional 7-day test at predicting success with the treatment.

What are the potential side effects?

Sacral neuromodulation may cause discomfort at the implant site, lead migration, infection risk, technical problems with the device, and it might not improve symptoms for everyone.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman over 18, not pregnant, getting SNM for UUI or UF, and have chosen to undergo a PNE test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have advanced pelvic organ prolapse or I currently use a pessary.

Select...

I have a significant neurological condition like MS, severe nerve damage, or a complete spinal cord injury.

Select...

I have stress urinary incontinence or mixed with stress being the main issue.

Select...

I have had surgery to modify my bladder muscle.

Select...

I have or had bladder cancer.

Select...

I have issues with holding urine or controlling bowel movements without blockage.

Select...

My diabetes is severe or not well-controlled, or it affects my nerves.

Select...

I currently have a urinary tract infection.

Select...

I have had radiation therapy to my pelvic area before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 or 7 days depending on treatment arm

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 or 7 days depending on treatment arm

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 or 7 days depending on treatment arm for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Rate of progression onto full sacral neuomodulation (SNM) implant

Secondary study objectives

Patient satisfaction

Quality of life scores

Rate of adverse events

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: 3-day trialExperimental Treatment1 Intervention

Patients randomized to the 3-day trial arm will undergo a 3-day PNE trial phase for sacral neuromodulation. Participants will have the PNE placed in the office and return on day 3 for PNE removal.

Group II: 7-day trialActive Control1 Intervention

Patients randomized to the73-day trial arm will undergo a 7-day PNE trial time for sacral neuromodulation. Participants will have the PNE placed in the office and return on day 7 for PNE removal.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sacral neuromodulation

2018

N/A

~140

0 / 10Eligibility criteria met