CompletedPhase 1

Study of V117957 in Overactive Bladder Syndrome

United States51 participantsStarted 2022-06-30

Plain-language summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with overactive bladder syndrome, compared to placebo.

Who can participate

Age range

18 Years – 70 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Female, age ≥18-70 years and capable of voiding independently. Able to comply with acceptable methods of contraception.
. Has symptoms of overactive bladder including (OAB) urinary urgency and urinary frequency with incontinence for ≥3 months.
. Willing to modify current OAB treatment regimen.

Exclusion criteria

. Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor.
. Urinary tract infection (UTI) within past 30 days, or history of recurrent UTI.
. Hematuria associated with bladder malignancy or other significant pathology.
. Had surgical procedure that affected bladder function.
. Received intravesical therapy within past 12 months or had bladder hydrodistention within past 6 months.
. Grade III/IV pelvic organ prolapse with/without cystocele or urethral diverticulum.
. Clinically significant kidney disease or nephrolithiasis.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in Micturition Episode Components (Micturition, Incontinence, and Urgency) Per 24 Hours.

Timeframe: Baseline, Weeks 2, and 8

Trial details

NCT IDNCT06024642

SponsorImbrium Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-21

Results submitted2025-05-21

View on ClinicalTrials.gov More Overactive Bladder Syndrome trials