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Completed

NCT Number: NCT00847535

An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence

This is a clinical investigation approved by US FDA and Canadian Health Authority to study the safety and potential effectiveness of the autologous muscle cells for the treatment of stress urinary incontinence.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Sunnybrook Health Sciences Center, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient has SUI with normal detrusor activity confirmed with urodynamics
  • Patient has bladder capacity >200 mL
  • Patient's incontinence has not shown any improvement for at least -6 months
  • Patient has failed prior treatments (e.g., behavior modification, bladder exercises, biofeedback, electrical stimulation, bulking injections, urethral suspensions and/or drug therapy)

Exclusion criteria

  • Patient has known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities with high pressure instability
  • Patient has a neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis)
  • Patient has uncontrolled diabetes
  • Patient is pregnant, lactating, or plans to become pregnant during the course of the study
  • Patient is morbidly obese (defined as 100 pounds over their ideal body weight, or BMI ≥40) and would not be expected to benefit from treatment
  • Patient has current or acute conditions involving cystitis or urethritis
  • Patient is scheduled to receive radiation treatment to the vicinity
  • Patients with a history of radiation treatment to the urethra or adjacent structures

Treatment and study plan

autologous muscle cell injection

Biological

Injection of autologous muscle cells

Primary outcomes

  1. Number of Participants That Experienced Biopsy Procedure-related Adverse Events

    Time frame: at biopsy or between biopsy and treatment

    Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received.

    All biopsy procedure-related events either self-resolved or were easily treated.

  2. Biopsy Procedure-related Adverse Events

    Time frame: at biopsy or between biopsy and treatment

    Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received.

    All biopsy procedure-related events either self-resolved or were easily treated.

  3. Number of Participants That Experienced Injection Procedure-related Adverse Events

    Time frame: 30 days

    AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received.

    All injection procedure-related events self-resolved or were easily treated.

  4. Injection Procedure-related Adverse Events

    Time frame: 30 days

    AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received.

    All injection procedure-related events self-resolved or were easily treated.

  5. Number of Participants That Experienced AMDC Product-related Adverse Events

    Time frame: 12 months

    If an immune response after injection or any urinary retention occurred and seemed suspicious, the physicians were consulted to determine whether the effect was likely related to the AMDC product.

    No adverse events reported during the study were adjudicated as AMDC product-related.

Sponsors and collaborators

Lead sponsor

Cook MyoSite

Industry

Registry information

Official study title

Muscle Cell Mediated Therapy for Stress Urinary Incontinence: An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells.

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Feb 19, 2009
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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