What side effects are associated with this type of intervention?

Common treatments for urinary incontinence that focus on strengthening or repairing the bladder neck/urethra include periurethral injections and surgical interventions. Known side effects of these treatments can include urinary tract infections, incomplete bladder emptying, and formation of collections or abscesses at the injection or surgical site. Additionally, patients may experience temporary pain or discomfort, and there is a risk of urinary retention or worsening incontinence in some cases.

What prior FDA approvals exist?

FDA-approved treatments for urinary incontinence have included various pharmacological and surgical interventions. Pharmacological treatments often involve anticholinergics and beta-3 adrenergic agonists, which help manage symptoms by affecting bladder muscle contractions. Surgical options include procedures like sling surgery and bulking agents, which aim to provide structural support to the bladder neck and urethra. While specific FDA approvals for autologous muscle fiber fragments are not detailed, similar approaches like bulking agents have been used to strengthen the bladder neck and urethra, providing a precedent for such regenerative therapies.

What other types of research exist?

Promising novel alternatives for treating urinary incontinence include: 1) Bioabsorbable self-reinforced poly L-lactic acid urethral stents, which have shown potential in pilot studies for treating benign prostatic enlargement-related urinary retention. 2) Urolift, a minimally invasive surgical option for benign prostatic hyperplasia, which may indirectly benefit urinary incontinence by improving bladder function. 3) Bioengineered skeletal muscle constructs with neuromuscular junctions, which aim to restore normal muscle function and could be applied to the pelvic floor muscles. 4) Tissue-engineered cholecyst-derived extracellular matrix (CDECM) grafts, which have shown promise in bladder wall regeneration and could potentially be adapted for urethral or bladder neck repair.

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Muscle Fiber Fragment Treatment for Urinary Incontinence

Phase 1 & 2

Recruiting

Led By Gopal Badlani, MD

Research Sponsored by Wake Forest University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with cystometric capacity of bladder > 100 ml

Patients between the ages of 18 and 75 years

Must not have

Patients with abnormal bladder capacity (i.e., less than 100 cc)

Patients with abnormal urologic conditions, including post-void residual, urethral stricture and bladder neck contracture, spastic bladder, vesicoureteral reflux, bladder stones, bladder tumors, hydronephrosis, other renal impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3, 6 and 12 months post-treatment

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, treatments involving autologous tissue may include risks such as infection at the injection site, pain or discomfort during recovery, allergic reactions to materials used during treatment and potential failure to improve incontinence symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My bladder can hold more than 100 ml of urine.

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I am between 18 and 75 years old.

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My kidney function is normal.

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I have urinary incontinence due to a weak sphincter.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My bladder can hold less than 100 cc of urine.

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I have a diagnosed bladder or kidney condition.

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I am taking medication that affects how often I urinate.

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I am currently using or need immunosuppressive medication.

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I do not have any muscle diseases or blood clotting disorders.

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I have a severe pelvic organ drop.

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My vaginal prolapse extends outside the vaginal opening.

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I have a neurological disorder.

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I have a history of bladder issues, including overactive or neurogenic bladder.

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I have not had any cell therapy in the last 12 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3, 6 and 12 months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3, 6 and 12 months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3, 6 and 12 months post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of treatment-related serious adverse events

Secondary study objectives

Change in Incontinence Assessment by Pad Test

Other study objectives

Change in number of incontinence episodes and pads used per day

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Autologous Muscle Fiber FragmentsExperimental Treatment1 Intervention

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

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for urinary incontinence often aim to strengthen or repair the bladder neck and urethra. Autologous muscle fiber fragment therapy, for instance, involves injecting muscle-derived cells to regenerate and strengthen the urethral sphincter, thereby improving its function. This is crucial for patients as it directly addresses the underlying muscle weakness or damage that contributes to incontinence. Other treatments, such as pelvic floor physical therapy, focus on strengthening the pelvic muscles to provide better support for the bladder. Pharmacologic therapies may also be used to modulate bladder muscle activity and improve control. These treatments are important as they can significantly improve the quality of life for patients by reducing or eliminating incontinence episodes.

Long-term effects of muscle-derived stem cell therapy on the regeneration of the urethra of female rats.Can autologous myoblasts be used as a potential bulking agent?The regeneration process of the striated urethral sphincter involves activation of intrinsic satellite cells.