Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study

NCT01382602 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 10-019
• Study Type: interventional
• Target: 150
• Locations: 3 countries
• Sites: 10

Brief Summary

This is a clinical trial to study the safety and effectiveness of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of female stress urinary incontinence (SUI).

Conditions

Urinary Incontinence, Stress

Keywords

Urinary Incontinence, Stress; Tissue Therapy (Cell Therapy); Transplantation, Autologous

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Response (Based on Stress IEF, or In-office Pad Weight Test, or 24-hour Pad Weight Test) at 12 Months

  A composite primary endpoint of responder rate was used, where a subject was considered a responder if she had ≥ 50% reduction from baseline in stress Incontinence Episode Frequency (stress IEF; reported stress leaks from 3-day diary) or ≥ 50% reduction in leakage from baseline as determined by either the in-office pad weight test or the 24-hour pad weight test.

  12 months

Study Arms (2)

AMDC-USR

EXPERIMENTAL

Subjects received 1 or 2 treatments of 150 million AMDC-USR delivered via transurethral intrasphincteric injection. After completing 12 months follow-up subjects were unblinded. Subjects were followed for 2 years after initial AMDC-USR treatment.

Biological: AMDC-USR

Placebo

PLACEBO COMPARATOR

Subjects received 1 or 2 treatments of placebo delivered via transurethral intrasphincteric injection. After completing 12 months follow-up subjects were unblinded and could elect to receive open-label AMDC-USR treatment. Subjects that received unblinded AMDC-USR treatment were followed for 2 years after initial placebo treatment.

Biological: Placebo

Interventions

AMDC-USR BIOLOGICAL

AMDC-USR Treatment

AMDC-USR

Placebo BIOLOGICAL

Placebo treatment

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patient has primary symptoms of SUI, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation.

You may not qualify if:

• Patient has symptoms of pure urge incontinence as confirmed by basic evaluation of etiology from a patient medical history, including a focused incontinence history.
• Patient has symptoms of mixed urinary incontinence where urge incontinence is the predominant factor.
• Patient has had stress urinary incontinence symptoms less than 6 months prior to signing the informed consent.
• Patient has not previously attempted conservative treatment for at least 1 month prior to signing the informed consent. (Examples of conservative treatment include behavior modifications, bladder exercises, biofeedback, etc.)
• Patient has more than 2 episode of awakening to void during normal sleeping hours.
• Patient cannot be maintained on a stable dose and/or frequency of medication (including diuretics) known to affect lower urinary tract function, including but not limited to, anticholinergics, tricyclic antidepressants or alpha-adrenergic blockers, for at least 2 weeks prior to randomization or is likely to change during the course of the study.
• Patient is pregnant, lactating, or plans to become pregnant during the course of the study.
• Patient refuses to provide written informed consent.
• Patient is not at least 18 years of age.
• Patient is not available for the follow-up evaluations as required by the protocol.

Sponsors & Collaborators

• Cook MyoSite: lead

Study Sites (10)

Foothills Medical Center

Calgary, Alberta, T2N 2T9, Canada

Location

Southern Alberta Institute of Urology

Calgary, Alberta, T2V 1P9, Canada

Location

Victoria Gynecology and Continence Clinic

Victoria, British Columbia, V8R 6R3, Canada

Location

Can-Med Clinical Research Inc.

Victoria, British Columbia, V8T 5G1, Canada

Location

Centre for Applied Urological Research Queens University

Kingston, Ontario, K7L 2V7, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1Z5, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Praxisklinik Urologie Rhein-Ruhr

Mülheim, 45468, Germany

Location

Worthing Hospital

Worthing, BN11 2DH, United Kingdom

Location

Related Publications (1)

• Fontaine F, Tu LM, Carroll MS, Morin M. Agreement between simple catheter method and 3D transperineal ultrasound for assessing urethral length measurement before stress urinary incontinence treatment. Neurourol Urodyn. 2018 Nov;37(8):2875-2880. doi: 10.1002/nau.23805. Epub 2018 Sep 3.

  PMID: 30178605 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Planned study enrollment was 246 patients; due to limitations in study design related to the primary efficacy endpoint, enrollment was halted early at 150 subjects.

Results Point of Contact

• Title: Ron Jankowski, PhD
• Organization: Cook MyoSite Incorporated

Ron.Jankowski@CookMyosite.com

412-963-7380

Study Officials

• Lesley K. Carr, MD, FRCSC

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: June 27, 2011
• Study Start: November 4, 2011
• Primary Completion: February 3, 2016
• Study Completion: January 29, 2017
• Last Updated: May 17, 2018
• Results First Posted: May 17, 2018

Record last verified: 2018-04

Locations

GB (1); DE (1); CA (8)