Stress Urinary Incontinence Study to Assess Safety and Efficacy of Muvon's Muscle Precursor Cell Therapy

NCT05534269 | Completed Phase 2 DMC

• 1 other identifier: SUISSE MPC2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the SUISSE MPC 2 study is to treat stress urinary incontinence in adult women.

Conditions

Female Stress Urinary Incontinence

Keywords

SUI; Incontinence; rhabdomyosphincter; urine; Stress Incontinence; LUTS; lower urinary tract

Outcome Measures

Primary Outcomes (1)

• Change of SUI episode frequency

  Assessment in episode change measured using a bladder diary, from baseline to 6 months after injection.

  8-9 months

Secondary Outcomes (3)

• Incidence of (S)AEs

  6-8 months

• Number of patients with any clinical significant findings

  8-9 months

• Change in 24 hour pad weight

  8-9 months

Other Outcomes (14)

• Change in total leakage episodes

  8-9 months

• Questionnaire ICIQ-UI SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form )

  8-9 months

• Questionnaire ICIQLUTSqol (International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms quality of Life)

  8-9 months

Study Arms (2)

Low dose

EXPERIMENTAL

Already human tested low dose from phase I study

Biological: autologous muscle precursor cells

High dose

EXPERIMENTAL

First in human dose used for efficacy reasons during phase II

Biological: autologous muscle precursor cells

Interventions

autologous muscle precursor cells BIOLOGICAL

Patients own Muscle Precursor Cells are isolated and injected into the rhabdomyosphincter

High dose; Low dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 detrusor instability or detrusor sphincter dyssynergia (DSD)
• Sensory urgency defined as first sensation of bladder fill (urge to void) of \<100 ml
• No sensation at any time during the simple filling cystometry procedure
• Known urethral Stenosis (ureterocystoscopy) or urethral diverticulum
• History of cancer (\< 5 year of remission) or history of pelvic radiotherapy

Sponsors & Collaborators

• University of Zurich: lead
• GCP-Service International Ltd. & Co. KG: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Links

• Website for Phase II Study

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tobias Schmidli, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Neither patient nor sponsor will know which patient gets which dose
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Low dose and High dose evaluation

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: September 9, 2022
• Study Start: October 17, 2022
• Primary Completion: July 14, 2025
• Study Completion: July 14, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)