Muscle Fiber Fragment Treatment for Urinary Incontinence

Overseen By Gopal Badlani, MD

Age: 18+

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: Wake Forest University

Must not be taking: Urination affecting drugs

Disqualifiers: Hypercontractile bladder, HIV, diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 1 day

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses a patient's own muscle tissue to help control urine leakage by injecting it into the bladder area. It targets patients with weak bladder muscles that can't properly control urine flow, aiming to strengthen these muscles and improve urine control. Research has explored using muscle cells for reconstructing the lower urinary tract.

Will I have to stop taking my current medications?

Yes, if you are taking any medications that affect urination, including prescription drugs, over-the-counter drugs, or dietary supplements, you will need to stop taking them to participate in this trial.

What data supports the effectiveness of the treatment for urinary incontinence?

Research shows that injecting autologous muscle-derived cells can effectively treat urinary incontinence, with studies reporting complete cure in many patients and improvements in others. This suggests that using muscle fiber fragments, which contain similar regenerative cells, could also be effective. ^{1 2 3 4 5}

Is the Muscle Fiber Fragment Treatment for Urinary Incontinence safe for humans?

Studies have shown that treatments using autologous muscle-derived cells, which are similar to muscle fiber fragments, have been evaluated for safety in humans for conditions like stress urinary incontinence and fecal incontinence. These studies generally report on the safety of the treatment over a 12-month period, suggesting it is safe for human use. ^{1 3 5 6 7}

How is the Muscle Fiber Fragment Treatment for Urinary Incontinence different from other treatments?

This treatment uses a patient's own muscle tissue, which is minced and injected to help regenerate muscle and improve urinary control, unlike other treatments that may use synthetic materials or donor tissues. It is a simpler and potentially more natural approach, as it involves using the body's own cells to repair and strengthen the affected area. ^{1 3 4 5 8}

Research Team

Gopal Badlani, MD

Principal Investigator

Wake Forest School of Medicine, Dept. of Urology

Eligibility Criteria

This trial is for adult women aged 18-75 with urinary incontinence due to bladder neck or urethral issues. They must not be pregnant, breastfeeding, and should use birth control if sexually active. Participants need a bladder capacity over 100 ml and normal kidney function. Excluded are those with neurological disorders, muscle diseases, coagulation problems, significant pelvic organ prolapse, recent cellular therapy or investigational drug use.

Inclusion Criteria

My bladder can hold more than 100 ml of urine.

I am between 18 and 75 years old.

My kidney function is normal.

Exclusion Criteria

My bladder can hold less than 100 cc of urine.

I have a diagnosed bladder or kidney condition.

I am taking medication that affects how often I urinate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a biopsy and receive a single injection of autologous muscle fiber fragments into the bladder neck sphincter region

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

5 visits (in-person) at 1 week, 6 weeks, 3 months, 6 months, and 12 months

Treatment Details

Interventions

• Autologous Muscle Fiber Fragments

Trial Overview The study tests the safety of autologous muscle fiber fragments as a treatment for urinary incontinence caused by sphincter insufficiency. It's aimed at helping those who have this condition due to either acquired (like stress incontinence) or congenital reasons.

Participant Groups

Group I: Autologous Muscle Fiber Fragments Experimental Treatment 1 Intervention

Autologous Muscle Fiber Fragments administered via a single,direct injection into the bladder neck sphincter region

Who Is Running the Clinical Trial?

Wake Forest University

Lead Sponsor

Trials

193

Recruited

151,000+

Findings from Research

Intraurethral injection of minced autologous skeletal muscle tissue is a safe and moderately effective treatment for stress urinary incontinence, with significant reductions in leakage and improved ICIQ-SF scores observed in both uncomplicated (25% cure rate) and complicated (7% cure rate) cases after 1 year.

This simpler procedure shows comparable efficacy to more complex regenerative therapies using expanded muscle-derived cells, with no development of voiding dysfunction and only minor adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraurethral injection of autologous minced skeletal muscle: a simple surgical treatment for stress urinary incontinence. Gräs, S., Klarskov, N., Lose, G.[2014]

In a study involving 42 patients with urinary stress incontinence, transurethral ultrasound-guided injections of autologous myoblasts and fibroblasts led to complete cure in 35 patients, demonstrating the efficacy of this new treatment approach.

No postoperative side effects or complications were reported, indicating a high safety profile for this innovative therapy using autologous stem cells to treat urinary incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Stem cell therapy for urinary incontinence]. Strasser, H., Marksteiner, R., Margreiter, E., et al.[2018]

A multicenter, placebo-controlled study showed that injecting high doses of autologous skeletal muscle-derived cells significantly improved fecal incontinence (FI) symptoms, particularly in patients with a shorter duration of FI and higher baseline incontinence episode frequency.

The treatment was safe, with no unexpected adverse events reported, and the benefits were sustained or increased over 12 months in the high cell count group, suggesting potential for this therapy in managing FI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skeletal Muscle-Derived Cell Implantation for the Treatment of Fecal Incontinence: A Randomized, Placebo-Controlled Study. Frudinger, A., Gauruder-Burmester, A., Graf, W., et al.[2023]

Injecting autologous muscle-derived cells into the bladder and urethra of female rats is feasible and shows significant persistence of these cells over time, with a notable presence at 30 days post-injection.

Compared to bovine collagen, which showed minimal persistence after 30 days, the muscle-derived cells maintained approximately 88% of their initial expression, suggesting they may be a more effective treatment option for stress urinary incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persistence and survival of autologous muscle derived cells versus bovine collagen as potential treatment of stress urinary incontinence. Yokoyama, T., Yoshimura, N., Dhir, R., et al.[2007]

In a study involving 8 children with bladder exstrophy, autologous myoblast injections significantly improved urinary continence, with 88% of patients achieving daytime dryness after an average follow-up of 15.3 months.

Urodynamic studies showed marked improvements in bladder capacity and function, indicating that this treatment could be a promising option for managing urinary incontinence in children, especially when combined with pelvic floor exercises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transurethral autologous myoblast injection for treatment of urinary incontinence in children with classic bladder exstrophy. Kajbafzadeh, AM., Elmi, A., Payabvash, S., et al.[2008]

In a study involving 80 women with stress urinary incontinence, autologous muscle-derived cells for urinary sphincter repair showed no adverse events, indicating a strong safety profile over 12 months.

The treatment demonstrated potential efficacy, with higher doses leading to greater improvements in urinary leakage and quality of life scores, suggesting a dose-response relationship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous muscle derived cells for treatment of stress urinary incontinence in women. Peters, KM., Dmochowski, RR., Carr, LK., et al.[2017]

The study involving 38 women showed that injecting autologous muscle-derived cells for stress urinary incontinence was safe, with only minor side effects like pain or bruising at the injection sites.

Patients receiving higher doses of these cells experienced significantly better outcomes, with a greater percentage achieving a 50% or more reduction in incontinence symptoms compared to those receiving lower doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous muscle derived cell therapy for stress urinary incontinence: a prospective, dose ranging study. Carr, LK., Robert, M., Kultgen, PL., et al.[2022]

In a phase I clinical trial involving 10 patients with intrinsic sphincter deficiency (ISD), periurethral implantation of myofibres containing muscle precursor cells (MPCs) significantly increased intraurethral pressure and improved continence, with four out of five women experiencing notable improvements over 12 months.

The procedure was found to be safe, with no serious side effects reported, indicating that myofibre implantation could be a promising one-step treatment for urinary incontinence due to ISD, although further research is needed to enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Periurethral skeletal myofibre implantation in patients with urinary incontinence and intrinsic sphincter deficiency: a phase I clinical trial. Yiou, R., Hogrel, JY., Loche, CM., et al.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Intraurethral injection of autologous minced skeletal muscle: a simple surgical treatment for stress urinary incontinence. [2014]

2. Germany pubmed.ncbi.nlm.nih.gov

[Stem cell therapy for urinary incontinence]. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Skeletal Muscle-Derived Cell Implantation for the Treatment of Fecal Incontinence: A Randomized, Placebo-Controlled Study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Persistence and survival of autologous muscle derived cells versus bovine collagen as potential treatment of stress urinary incontinence. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

Transurethral autologous myoblast injection for treatment of urinary incontinence in children with classic bladder exstrophy. [2008]

6. United States pubmed.ncbi.nlm.nih.gov

Autologous muscle derived cells for treatment of stress urinary incontinence in women. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Autologous muscle derived cell therapy for stress urinary incontinence: a prospective, dose ranging study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Periurethral skeletal myofibre implantation in patients with urinary incontinence and intrinsic sphincter deficiency: a phase I clinical trial. [2015]