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Pill or needle? new study tests two treatments for bladder leaks

NCT ID NCT05806164

Symptom relief Sponsor: Women and Infants Hospital of Rhode Island Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Updated 2 times

Summary

This study compares two treatments for women with urgency urinary incontinence (sudden, strong urges to urinate that lead to leakage). Participants will be randomly assigned to take an oral beta-agonist pill or receive Botox injections into the bladder. The main goals are to see which treatment women are more satisfied with and which better reduces their symptoms, with follow-up lasting up to 5 years.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 432 people

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

Started

Jun 2023

Expected to finish

Aug 2030

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\*: 1. 18 years or older 2. report at least "quite a bit bothered" or worse by their UUI defined by response to OAB-q-SS item #8 "How bothered are you by urine loss associated with a strong desire to urinate?" 3. are not and do not plan to become pregnant 4. have persistent UUI defined as previous unsuccessful results after conservative and anticholinergic treatment, or are unable to tolerate or have contraindications to anticholinergics 5. are currently not taking anticholinergics or are willing to stop medication for 3 weeks prior to enrollment. 6. for participants reporting mixed urinary incontinence symptoms, participant must (a) have less bother from SUI than from UUI, defined as a response of "Not at all bothered" or only "a little bit bothered" by SUI on the Urogenital Distress Inventory item "Do you experience urine leakage related to physical activity? (walking, running, laughing, sneezing, coughing), and (b) SUI symptoms be stable (\> 3 months), and (c)participant does not desire additional treatment for SUI in the upcoming 3 months. 7. Participants after unsuccessful neuromodulation trial can be eligible after a 4-week washout period. Exclusion criteria: 1. clinical contraindication to beta-3 agonist or onabotulinumtoxinA 2. prior therapeutic trial of either study treatment 3. unevaluated hematuria, current or prior bladder malignancy 4. surgically altered detrusor muscle 5. prior pelvic radiation 6. post-void residual \>150 mL in past 3 months 7. neurogenic bladder 8. pelvic floor surgery within the past 3 months 9. anticipating pelvic surgery within primary outcome follow up period (3 months)

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Conditions

The condition(s) this trial relates to.

overactive bladder

As listed by the trial registrant

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

Urgency urinary incontinence

Contacts and locations

Locations

  • Howard University

    Washington D.C., District of Columbia, 20059, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of California, San Diego

    San Diego, California, 92093, United States

  • University of New Mexico

    Albuquerque, New Mexico, 87131, United States

  • Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905, United States

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