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Could a 3-Day test be enough for bladder device success?

NCT ID NCT06226220

Symptom relief Sponsor: University of Chicago Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a 3-day trial of a nerve-stimulating device for bladder control works as well as the standard 7-day trial. About 193 women with urgent or frequent urination will be randomly assigned to either a 3-day or 7-day test. The goal is to see if the shorter trial leads to similar rates of getting the permanent implant.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sacral neuromodulation (electrical stimulation device)
What this could lead to
If successful, this could make the testing phase for a bladder control device shorter and more convenient, potentially leading to faster treatment.
What could go wrong
This is an early-stage study comparing two trial lengths, not testing a new treatment. The shorter trial may not predict long-term success as well as the longer one.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 193 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * \>/=5 UUI episodes on a 3-day bladder diary with urge incontinence representing \>/=50% of total incontinence episodes recorded or \>/=8 per day for 2 days on a 3-day bladder diary * Willing and able to complete all study related items and interviews * Grossly neurologically normal exam Exclusion Criteria: * SNM indication of non-obstructive urinary retention or isolated fecal incontinence * Severe or poorly controlled diabetes (defined as HgbA1c \>/=8.0) or diabetes with peripheral nerve involvement * Neurological diseases such as multiple sclerosis, clinically significant peripheral neuropathy, or complete spinal cord injury * Surgically altered detrusor muscle (i.e. Augmentation cystoplasty) * Current or prior bladder malignancy * Prior pelvic irradiation * Post void residual (PVR) \>/= 150 mL within 6 months prior to enrollment * Active urinary tract infection * Primary stress urinary incontinence or mixed urinary incontinence with stress predominance * \>/= Stage III pelvic organ or vaginal vault prolapse and/or current pessary use

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Conditions

The condition(s) this trial relates to.

overactive bladder urethral syndrome Urinary Incontinence Urinary Incontinence, Urge

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Overactive bladder Urge incontinence Urgency-frequency syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.