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 range18 Years – 70 Years

SexFEMALE

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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.

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