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Procedure

3-day trial for Overactive Bladder

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 or 7 days depending on treatment arm

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of progression onto full sacral neuomodulation (SNM) implant

Secondary outcome measures

Patient satisfaction

Quality of life scores

Rate of adverse events

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brown UniversityOTHER

456 Previous Clinical Trials

558,151 Total Patients Enrolled

University of ChicagoLead Sponsor

1,004 Previous Clinical Trials

819,584 Total Patients Enrolled

Atrium Health Wake Forest BaptistUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for patients to participate in this medical study?

"According to the details available on clinicaltrials.gov, this research study is currently open for enrollment. The initial posting date was December 10th, 2023, and it has been updated most recently on January 16th, 2024."

Answered by AI

What is the upper limit on the number of participants involved in this clinical investigation?

"Indeed, the information available on clinicaltrials.gov indicates that this particular study is currently actively seeking eligible patients. The trial was initially posted on December 10th, 2023 and underwent its most recent update on January 16th, 2024. To fulfill the requirements of the study, a total of 193 participants are being sought from a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Percutaneous Nerve Evaluation Trial Time

2023. "Percutaneous Nerve Evaluation Trial Time". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06226220.

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