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New trial aims to ease bladder troubles in Parkinson's patients

NCT ID NCT07187466

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Updated 2 times

Summary

This study tests two treatments—mirabegron (a drug) and exercise-based behavioral therapy—for overactive bladder in people with Parkinson's disease. Researchers want to see if combining treatments helps those who don't respond to one alone. The trial will involve 146 participants and measure symptom changes over 12 weeks.

What this could mean

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

Active substance
mirabegron (Myrbetriq) and exercise-based behavioral therapy
What this could lead to
If successful, this could provide a clear treatment plan for managing overactive bladder symptoms in people with Parkinson's disease, improving their quality of life.
What could go wrong
This is a phase 4 trial with 146 participants, so results may not apply to everyone. The treatments may not work for all, and mirabegron can cause side effects like increased blood pressure or urinary tract infection.

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 146 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

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

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Clinical diagnosis of PD determined by a board-certified neurologist with specialty training in movement disorders * An ICIQ-OAB Symptom Score of 7 or higher, which indicates clinically significant symptoms of OAB, defined as presence of urinary urgency with or without urgency incontinence usually with increased daytime frequency and nocturia in the absence of infection or other obvious pathology Exclusion Criteria: * Significant cognitive impairment, as indicated by a Montreal Cognitive Assessment (MoCA) score of \< 18 or a telephone-MoCA score \< 13, which is the recommended diagnostic cut point for dementia in PD. * Previous intensive pelvic floor muscle exercise training * Clinically significant depression as measured by a Geriatric Depression Scale-Short Form score of 10 or higher which could affect motivation to fully engage in the intervention * Use of an indwelling urinary catheter * Post-void residual urine measurement by bladder ultrasound of \> 150 mL * Severe uterine prolapse past the vaginal introitus * Poorly controlled diabetes defined by a hemoglobin A1c (HgbA1c) of \>9.0% within the last 3 months. Participants with poorly controlled diabetes will be offered enrollment if the OAB symptoms persist after improvement in diabetes control * Chronic renal failure and on hemodialysis * Genitourinary cancer with ongoing surgical or external beam radiation treatment * Previous artificial urinary sphincter, sling procedure or implanted sacral neuromodulation device * History of bladder-injection of botulinum toxin in the last 12 months * Any unstable health condition expected to result in hospitalization or death within in the next 3 months as determined by principal investigator. * Hypersensitivity to drug class * Contraindication to the study drug (mirabegron) including history of acute urinary retention requiring catheterization * Current use of a bladder relaxant - permitted to enroll after one-week washout * Hematuria on microscopic examination in the absence of infection. A urologic consultation will be recommended, and enrollment will depend on clearance by a urologist and agreement by the site PI that entry into the treatment protocol is not contraindicated * If on diuretic, dose should be stable for at least 4 weeks * If taking an alpha-blocker, dose should be stable for at least 4 weeks * If taking dutasteride or finasteride, dose should be stable for at least 6 months

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    3 sites. 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

  • Atlanta VA Medical and Rehab Center, Decatur, GA

    Decatur, Georgia, 30033-4004, United States

  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

    Philadelphia, Pennsylvania, 19104-4551, United States

  • VA Salt Lake City Health Care System, Salt Lake City, UT

    Salt Lake City, Utah, 84148-0001, United States

More trials for these conditions

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