Stress Urinary Incontinence Study to Assess Safety and Efficacy of Muvon's Muscle Precursor Cell … (NCT05534269) | Clinical Trial Compass
CompletedPhase 2
Stress Urinary Incontinence Study to Assess Safety and Efficacy of Muvon's Muscle Precursor Cell Therapy
Switzerland30 participantsStarted 2022-10-17
Plain-language summary
The objective of the SUISSE MPC 2 study is to treat stress urinary incontinence in adult women.
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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:
* Predominant clinical diagnosis of SUI
* Stress incontinence ≥ grade I for at least 6 months
* Patient has at least once been treated with, and failed prior conservative treatments
* Patient had no improvement of SUI symptoms for at least 6 months before enrollment
* Patients with a certain amount of leaks or /and a predefined pad weight at screening
* Candidate for a surgical treatment
* Negative blood test: Human immunodeficiency virus (HIV 1/2), Hepatitis B HBsAg, Anti HBc, Hepatitis C, Anti-HCV-Ab and Syphilis
* Negative laboratory or blood test, and medical examination to eliminate risk of sexually transmitted diseases (STD) per investigators' discretion
* Competent to comprehend, sign, and date informed consent form before any study-specific procedure is performed
* Able to communicate well with the Investigator, and to understand and comply with the requirements of the study including answering the required questionnaires
Exclusion Criteria:
* History of anti-incontinence surgery or prolapse surgery.
* Prolapse
* Diagnosed Hypermobile Urethra
* Previous diagnosis of any of the following conditions, disorders, or diseases of the urinary tract:
* Clinically significant cystocele or rectocele
* Ureteric bladder, urethral or rectal fistula
* Uncorrected congenital abnormality leading to urinary incontinence
* Interstitial cystitis
* Urinary urgency that results in leakage (as a predominant symptom)
* Adult enuresis
* Urodynamically proven d…