Autologous Cell Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery

NCT02291432 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 13-11
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 5

Brief Summary

To study the safety and potential efficacy of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of male stress urinary incontinence (SUI) for patients that have undergone prior prostate surgery.

Conditions

Urinary Incontinence; Stress; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations

Keywords

Urinary Incontinence, Stress; Tissue Therapy (Cell Therapy)

Outcome Measures

Primary Outcomes (2)

• Rate of Product-related, Biopsy Procedure-related, and Injection Procedure-related Adverse Events

  Safety of AMDC-USR following treatment of SUI in male patients who have undergone prior prostate surgery was determined by the frequency and severity of adverse events related to study procedures and study product through 24 months following treatment of SUI in male patients who have undergone prior prostate surgery.

  24 months

• Volume of Post-void Residual (PVR) Urine

  Post void residual volume (PVR) was assessed through 12 months post-treatment to monitor potential retention or obstruction.

  1, 3, 6, and 12 months

Secondary Outcomes (8)

• Change From Baseline in Amount of Urine Leakage (Median 24 Hour Pad Weight)

  1, 3, 6, and 12 months

• Number of Participants With a Change From Baseline in Amount of Urine Leakage (Categorial ≥50% Reduction in 24-hour Pad Weight)

  1, 3, 6, and 12 months

• Median Change From Baseline in Patient-reported Quality of Life (QOL) - Incontinence Quality of Life (I-QOL) Questionnaire

  1, 3, 6, and 12 months

• Median Change From Baseline in Patient-reported Symptom Severity- International Consultation on Incontinence Questionnaire (ICIQ)

  Baseline, 1, 3, 6, and 12 months

• Median Change in Patient-reported Incontinence Symptom Severity - International Prostate Symptom Score (I-PSS) Questionnaire

  Baseline, 1, 3, 6, and 12 months

Study Arms (1)

AMDC-USR

EXPERIMENTAL

Cell treatment

Biological: autologous muscle-derived cells (AMDC)

Interventions

autologous muscle-derived cells (AMDC) BIOLOGICAL

Cell treatment

AMDC-USR

Eligibility Criteria

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

You may qualify if:

• Male, at least 18 years old, with primary symptoms of SUI following prostate surgery,
• Patient has undergone prostate surgery but has not undergone radiation therapy, cryotherapy, or high-intensity focused ultrasound of the prostate,
• SUI severity should be ≥10 g and \<400 g of urine leakage over 24 hours,
• Patient has failed to achieve acceptable resolution of SUI symptoms following prior therapy.

You may not qualify if:

• Symptoms of only urge urinary incontinence,
• Symptoms of stress urinary incontinence prior to prostate surgery,
• Routinely has more than 2 episodes of awakening to void during normal sleeping hours,
• Compromised immune system due to disease state, chronic corticosteroid use, or other immunosuppressive therapy,
• Previously treated with a periurethral balloon or adjustable sling for urinary incontinence,
• Symptoms of overflow incontinence
• Additional medical restrictions as specified in the Clinical Investigation Plan,
• Additional anatomical restrictions as specified in the Clinical Investigation Plan.

Sponsors & Collaborators

• Cook MyoSite: lead

Study Sites (5)

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

McKay Urology

Charlotte, North Carolina, 28207, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Urinary Incontinence; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

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

Ron.Jankowski@CookMyosite.com

412-963-7380

Study Officials

• Kenneth Peters, MD

  Beaumont Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: November 14, 2014
• Study Start: February 19, 2015
• Primary Completion: June 28, 2019
• Study Completion: June 28, 2019
• Last Updated: November 1, 2021
• Results First Posted: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)