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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-09

Study Completion Date

2011-11-02

Brief Summary

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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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Detailed Description

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Conditions

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Stress Urinary Incontinence Cell Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Transurethral dose escalation

Group Type OTHER

autologous muscle cell injection

Intervention Type BIOLOGICAL

Injection of autologous muscle cells

2

Periurethral dose escalation

Group Type OTHER

autologous muscle cell injection

Intervention Type BIOLOGICAL

Injection of autologous muscle cells

Interventions

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autologous muscle cell injection

Injection of autologous muscle cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No