A Phase 2a Study To Evaluate VMB-100 In Females With Stress Urinary Incontinence (NCT06247241) | Clinical Trial Compass
WithdrawnPhase 2
A Phase 2a Study To Evaluate VMB-100 In Females With Stress Urinary Incontinence
Stopped: The study has not enrolled study participants, and will not start enrolling, due to insufficient funding and is withdrawn from .
0Started 2025-09
Plain-language summary
The study drug VMB-100 is an mRNA encoding for IGF-1. It is administered by injection into the urethra sphincter, and taken up by the muscle cells. The IGF-1 acts to promote muscle regeneration in the sphincter, which is expected to improve the function of the sphincter and thereby alleviate incontinence (urinary leakage).
Who can participate
Age range
18 Years – 55 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.
Main inclusion criteria:
* Pre- or peri-menopausal female subject between 18 and 55 years of age
* Body mass index (BMI) of 19 to 35 kg/m2
* Active SUI of moderate severity for at least 6 consecutive months documented in medical history
* Refractory to standard of care measures
* Must not be pregnant, lactating, or actively trying to become pregnant.
Main exclusion criteria:
* Any concurrent condition or any clinically significant abnormality at Screening which in the opinion of the Investigator may affect the interpretation of safety or efficacy data or which otherwise contradicts participation in a clinical study with VMB-100
* Unwilling to undergo transvaginal sonography or cystoscopy
* Urodynamic detrusor overactivity
* History of urinary urge incontinence of neurogenic etiology.
* History of or planning for pelvic radiation.
* History of use of any bulking agent or Botox to treat SUI in the past 12 month.
* History of urethral sling, anterior prolapse repair, and/or other SUI procedures or surgical procedures affecting continence.
* Taking any medications that are known to have an effect on urinary continence or medications that may exacerbate incontinence
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
1
Safety following VMB-100 administration
Timeframe: from baseline/preinjection through study completion (est average 1 year)
2
Safety following VMB-100 administration
Timeframe: immediately after the intervention through study completion (est average 1 year)
3
Safety following VMB-100 administration
Timeframe: immediately after the intervention through study completion (est average 1 year)
4
Tolerability of VMB-100 injection, pain
Timeframe: periprocedurally
5
Vital signs following VMB-100 administration
Timeframe: from baseline/preinjection through study completion (est average 1 year)
6
12-lead ECG following VMB-100 administration
Timeframe: from baseline/preinjection through study completion (est average 1 year)
7
Clinical laboratory measurements following VMB-100 administration