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Completed

NCT Number: NCT01008943

Autologous Cell Therapy for Female Stress Urinary Incontinence

The Autologous Cell Therapy for Female SUI study is a clinical trial to determine the safety and potential effectiveness of a single dose of 200 million Cook MyoSite Autologous Muscle Derived Cells for treatment of Stress Urinary Incontinence.

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Key information

Conditions

Stress Urinary Incontinence 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

Foothills Medical Centre, Calgary, Alberta, 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

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

Exclusion criteria

  • Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities with high pressure instability
  • Neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis)
  • Uncontrolled diabetes
  • Pregnant, lactating, or plans to become pregnant during course of the study
  • Morbid obesity (defined as 100 pounds over their ideal body weight, or BMI ≥40) and not expected to benefit from treatment
  • Current or acute conditions involving cystitis or urethritis
  • Scheduled to receive radiation treatment to the vicinity, or history of radiation treatment to the urethra or adjacent structures

Treatment and study plan

Autologous Muscle Derived Cells

Biological

Urethral injection of autologous muscle-derived cells

Primary outcomes

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

    Time frame: at biopsy or between biopsy and treatment, approximately 6 weeks

    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. 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.

  3. 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. Number of Participants That Experienced AMDC Product-related 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

A Canadian Prospective Nonrandomized Study of Autologous Cell Therapy for Female Stress Urinary Incontinence

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 6, 2009
Registry last updated
Jul 1, 2021

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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