Female Stress Urinary IncontinencePhase 2SUISSE MPC2NCT05534269
Stress Urinary Incontinence Study to Assess Safety and Efficacy of Muvon's Muscle Precursor Cell Therapy
A Phase 2 study testing autologous muscle precursor cells in people with Female Stress Urinary Incontinence, run by University of Zurich at 1 site in Switzerland.
Trial summary
The objective of the SUISSE MPC 2 study is to treat stress urinary incontinence in adult women. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Female Stress Urinary Incontinence
- What is being tested?
- autologous muscle precursor cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Oct 2022to 14 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- Immunosuppressed patients
- Women who are pregnant or become pregnant during the course of the study, breast feeding or <12 months postpartum
- Untreated symptomatic urinary tract infection
- Fever (as defined by ≥ 38,5°C, axillar measurement), any infectious disease, cold or flu within the last 7 days
- Unstable severe systemic disease including uncontrolled hypertension, unstable angina, or myocardial infarction, severe coagulation disorders, bleeding diathesis, emboli, thrombophlebitis, infectious diseases, poor wound healing, and poorly controlled diabetes mellitus within 6 months before enrolment
- Known allergy/intolerance to at least one of the active ingredients or excipients of the investigational products
- Known allergy/intolerance to Penicillin or Streptomycin.
- Known genetically determined or acquired muscular disease, known neurological disorder (Parkinson's disease, multiple sclerosis, spina bifida, medullary traumatism, Creutzfeldt-Jakob disease).
- Medication regimen including estrogens, anti-estrogens or diuretics where dose and/or frequency has not been stable for at least the past 12 weeks or is anticipated to change during the course of the study.
- Chronic use of defined drugs and not stopped prior to inclusion into or including the study. Selective serotonin and norepinephrine reuptake inhibitor antidepressant (SSNRI), alpha-receptor antagonists/agonists, beta-3-receptor agonists or anticholinergic/-muscarinic drugs.
- Have any clinically significant coexisting condition or symptoms that, in the opinion of the investigator, would put the safety of the participant at risk.
- Any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results.
- Medication known to affect lower urinary tract function.
- Patients having any electrical device inside their body (such as a cochlear implant, TENS stimulator (for pain), vagal nerve stimulator, brain stimulator, gastric pacemaker, bladder stimulator, or an implanted mechanical pump (such an insulin pump or pain pump).
- Patients having a cardiac pacemaker or defibrillator implant.
- Patients with Starr-Edwards artificial heart valve.
- Patients that suffer from claustrophobia.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich
Zurich, Canton of Zurich, 8091
About this study
The objective of the SUISSE MPC 2 study is to treat stress urinary incontinence in adult women.
Read the detailed description
Stress urinary incontinence (SUI) is the loss of small amounts of urine associated with coughing, laughing, sneezing, exercising or other activities that increase pressure on the abdomen and, subsequently, the bladder.
The goal of the SUISSE MPC2 study is to treat SUI in women using their own autologous muscle precursor cells. To generate enough outcome data, a sufficient number of patients will be enrolled to yield evaluable data from 30 patients.
The study will be conducted as a self-controlled case series (SCCS) with each patient serving as their own comparators. Patients will participate in the study for up to approximately 8 to 9 months, including a baseline visit for screening, a visit to obtain a muscle biopsy approximately 12 weeks later, an injection of MPCCOLs up to 5 weeks later, and follow-up visits at 1, 3 and 6 months post injection. The injection is performed with ultrasound guidance using an endocavity ultrasound probe mounted on an Injection Device specifically designed for the clinical trial.
All patients will be treated with one of two doses of MPCCOL, assigned according to the study's randomization method.
Half of the participating patients will receive the tissue engineered product (TEP) dose that was previously studied in the completed phase I study. The other half of the participants will receive a higher dose of the cell therapy to investigate the effects of dose increase. All study participants will be monitored via medical examinations.
Separate from the Principal Investigator, safety events will be reported to and investigated by an independent Data Safety Monitoring Board (DSMB) consisting of independent physicians and experts in the field. Data regarding the functionality and safety of the Injection Device will also be collected.
- Conditions
- Female Stress Urinary Incontinence
- Being tested
- autologous muscle precursor cells
- Keywords
- SUI, Incontinence, rhabdomyosphincter, urine, Stress Incontinence, LUTS, lower urinary tract
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous muscle precursor cellsBiological
Patients own Muscle Precursor Cells are isolated and injected into the rhabdomyosphincter
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | Already human tested low dose from phase I study Receives: Biological: autologous muscle precursor cells |
| High dose | Experimental | First in human dose used for efficacy reasons during phase II Receives: Biological: autologous muscle precursor cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of SUI episode frequency
Assessment in episode change measured using a bladder diary, from baseline to 6 months after injection.
Measured: 8-9 months
Secondary outcomes (3)
Incidence of (S)AEs
AEs related to obtaining biopsy, injection procedure and MPCs, including surgical injury, scars, urinary tract infection, inflammation, pelvic pain, prolonged urinary retention, voiding dysfunction, de novo urge incontinence, haematuria, aberrant tissue formation.
Measured from Visit 2 (biopsy) to End of Study.
Measured: 6-8 months
Number of patients with any clinical significant findings
Number of patients with any clinically significant findings based on physical examination, standard haematology, clinical chemistry and urinalysis profiles, blood pressure (BP), pulse and adverse events recordings at baseline, 1 month, 3 months and 6 months post-implantation.
Measured: 8-9 months
Change in 24 hour pad weight
Change in pad weight based on using regular pad tests, from baseline to 6 months after injection.
Measured: 8-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start17 Oct 2022
- Primary completion14 Jul 2025
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Low dose and High dose evaluation
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- GCP-Service International Ltd. & Co. KG
- Responsible party
- Sponsor
- Investigators
- Tobias Schmidli, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534269
- Sponsor's protocol ID
- SUISSE MPC2
- Acronym
- SUISSE MPC2
- Status last verified
- Jul 2025
- First submitted
- 23 Aug 2022
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Urinary Incontinence Study to Assess Safety and Efficacy of Muvon's Muscle Precursor Cell Therapy
- ClinicalTrials.gov ID
- NCT05534269
- Acronym / sponsor ID
- SUISSE MPC2 / SUISSE MPC2
- Conditions
- Female Stress Urinary Incontinence
- Keywords
- SUI, Incontinence, rhabdomyosphincter, urine, Stress Incontinence, LUTS, lower urinary tract
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- GCP-Service International Ltd. & Co. KG
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 9 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the SUISSE MPC 2 study is to treat stress urinary incontinence in adult women.
Detailed description
Stress urinary incontinence (SUI) is the loss of small amounts of urine associated with coughing, laughing, sneezing, exercising or other activities that increase pressure on the abdomen and, subsequently, the bladder.
The goal of the SUISSE MPC2 study is to treat SUI in women using their own autologous muscle precursor cells. To generate enough outcome data, a sufficient number of patients will be enrolled to yield evaluable data from 30 patients.
The study will be conducted as a self-controlled case series (SCCS) with each patient serving as their own comparators. Patients will participate in the study for up to approximately 8 to 9 months, including a baseline visit for screening, a visit to obtain a muscle biopsy approximately 12 weeks later, an injection of MPCCOLs up to 5 weeks later, and follow-up visits at 1, 3 and 6 months post injection. The injection is performed with ultrasound guidance using an endocavity ultrasound probe mounted on an Injection Device specifically designed for the clinical trial.
All patients will be treated with one of two doses of MPCCOL, assigned according to the study's randomization method.
Half of the participating patients will receive the tissue engineered product (TEP) dose that was previously studied in the completed phase I study. The other half of the participants will receive a higher dose of the cell therapy to investigate the effects of dose increase. All study participants will be monitored via medical examinations.
Separate from the Principal Investigator, safety events will be reported to and investigated by an independent Data Safety Monitoring Board (DSMB) consisting of independent physicians and experts in the field. Data regarding the functionality and safety of the Injection Device will also be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Low dose and High dose evaluation
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Biological: autologous muscle precursor cellsAlready human tested low dose from phase I study |
| High dose | Experimental | Biological: autologous muscle precursor cellsFirst in human dose used for efficacy reasons during phase II |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (32 listed)
- 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:
- Urinary urgency that results in leakage (as a predominant symptom)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous muscle precursor cellsPatients own Muscle Precursor Cells are isolated and injected into the rhabdomyosphincter | Biological | High dose, Low dose |
Primary outcome
Change of SUI episode frequency
Time frame: 8-9 months
Assessment in episode change measured using a bladder diary, from baseline to 6 months after injection.
3 secondary outcomes
Incidence of (S)AEs
Time frame: 6-8 months
Number of patients with any clinical significant findings
Time frame: 8-9 months
Change in 24 hour pad weight
Time frame: 8-9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Website for Phase II StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Schmidli, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing autologous muscle precursor cells in people with Female Stress Urinary Incontinence, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of SUI episode frequency (time frame: 8-9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.