A Phase 2a Study To Evaluate VMB-100 In Females With Stress Urinary Incontinence

Launched by VERSAMEB AG · Jan 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called VMB-100 for women who experience stress urinary incontinence (SUI). SUI is a condition that causes accidental leaking of urine during activities like coughing, sneezing, or exercising. VMB-100 is an injection that is given into the urethra, where it helps muscle cells regenerate and improve the function of the sphincter muscle, which might reduce urinary leakage.

To be eligible for this trial, women must be between 18 and 55 years old, have a body mass index (BMI) between 19 and 35, and have been experiencing moderate SUI for at least six months without finding relief from standard treatments. Participants should not be pregnant or breastfeeding, and there are some medical conditions that might prevent someone from joining the study. If you choose to participate, you'll receive the injection and will be monitored to see how well the treatment works. This trial is not yet recruiting participants, but it aims to help improve the lives of women dealing with this challenging condition.

Gender

FEMALE

Eligibility criteria

• 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