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

Female Stress Urinary Incontinence Clinical Trial

— SUISSE MPC2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05534269
• Other study ID #: SUISSE MPC2
• Status: Recruiting
• Phase: Phase 2
• Start date: October 17, 2022
• Est. completion date: November 2025

Study information

• Verified date: October 2023
• Source: University of Zurich
• Contact: Markus Veit
• Phone: +41442551223
• Email: markus.veit[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Stress urinary incontinence is the loss of small amounts of urine associated with coughing, laughing, sneezing, exercising or other movements that increase pressure on the abdomen and therefore increasing the pressure on the bladder.

The goal of the SUISSE MPC2 study is to treat SUI in women using their own autologous muscle precursor cells. To guarantee enough outcome data, a sufficient number of patients will be enrolled to complete the study with 70 patients.

The study will last approximately 8-9 months per patient. Each patient's baseline measurements serve as comparison for the treated measurements.

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 up to 12 weeks later, an injection of MPCs up to 5 weeks later, and follow-up visits after 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 the two doses of MPCs, assigned according to the study's randomization method.

Half of the participating patients will receive the cell therapy 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. Both groups of patients will be additionally monitored by medical examinations performed by clinicians to ensure the safety of the treatment.

Furthermore, separate to the Principal Investigator, safety events will be reported to and investigated by the independent Data Safety Monitoring Board consisting of independent physicians and experts in the field. Data regarding the functionality and safety of the Injection Device will also be collected.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 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.

Related Conditions & MeSH terms

• Enuresis
• Female Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Biological:
• autologous muscle precursor cells
Patients own Muscle Precursor Cells are isolated and injected into the rhabdomyosphincter

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	GCP-Service International Ltd. & Co. KG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in total leakage episodes	Response rate at 6 months, defined as percentage of patients with at least 50% change in number of stress leaks	8-9 months
Other	Questionnaire ICIQ-UI SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form )	Change in score from baseline to 6 months. Containing 1 scale ranging from 0 (not at all) to 10 (serious) measuring the impairment caused by urine leakage in everyday life.	8-9 months
Other	Questionnaire ICIQLUTSqol (International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms quality of Life)	Change in score from baseline to 6 months. This questionnaire contains 21 questions to measure the impact of urinary incontinence on quality of life with particular reference to social effects. Each question is accompanied by a scale to capture the subjective restriction concerning the respective topic. These scales range from 0 (not at all) to 10 (very much).	8-9 months
Other	Questionnaire VAS (Visual analogue scale)	Change score for degree of suffering, quality of life overall and subjective health status from baseline to 6 months. Scales ranging from 0 to 10. For Quality of life and health status from 0 "very bad" to 10 "very well". The degree of suffering from 0 (low) to 10 (high).	8-9 months
Other	Urethral pressure profile	It measures the changes in the bladder pressure (in cm/H2O) required to urinate and the flow rate (in ml/s) a given pressure generates between baseline and 6 months after injection.	8-9 months
Other	Urodynamic cystometric test	It measures the change of how much urine (in mL) the bladder can hold, between baseline and 6 months after injection.	8-9 months
Other	Urodynamic cystometric test	It measures the change how much pressure builds up inside the bladder (in cm/H2O) as it stores urine, between baseline and 6 months after injection.	8-9 months
Other	Urodynamic cystometric test	It measures the change how full the bladder is (in mL) when the urge to urinate occurs, between baseline and 6 months after injection.	8-9 months
Other	Urodynamic leak point pressure measurement	It measures the changes of pressure (in cm/H2O) at the point of leakage between baseline and 6 months after injection.	8-9 months
Other	% of subjects with successful injection	at day of implantation	1 day
Other	MRI evaluation: Increase of sphincter diameter and (S)AEs	MRI examinations of the rhabdomyosphincter at baseline visit and after ca. 6 months after the MPC injection at the end of the study. This means approximately 8-9 months after the baseline visit.; During the MRI we will measure the increase in sphincter diameter as well as looking for potential aberrant tissue formation and necrosis. The outcome will be reportet via MRI-pictures and data measurement provided by a Radiologist via the internal hospital system.	8-9 months
Other	PGI-I Questionnaire	Response to Patient Global Impression of Improvement Questionnaire, ca. 6 months after MPC injection at end of study visit.	8-9 months
Other	Device deficiency, ADEs and SADEs related to the Injection Device	Device deficiencies and Adverse Device Events and Serious Adverse Device Events regarding the Injection Device used during the MPC injection step.	6-8 months
Other	1 hour pad test	Reduction in weight of standardized 1 hour pad test; From visit 3 (injection) to end of study visit. The pad test will be performed at the clinic under supervision of a member of the study personnel.	6-8 months
Primary	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	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.	6-8 months
Secondary	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.	8-9 months
Secondary	Change in 24 hour pad weight	Change in pad weight based on using regular pad tests, from baseline to 6 months after injection.	8-9 months

External Links

•   Website for Phase II Study