ProACT Therapy for the Treatment of Stress Urinary Incontinence in Males

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Uromedica.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Uromedica
ClinicalTrials.gov Identifier:
NCT00277095
First received: January 11, 2006
Last updated: June 10, 2011
Last verified: May 2011
  Purpose

The purpose of the study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 109 male patients. The ProACT device is designed to treat men who have stress urinary incontinence arising from intrinsic sphincter deficiency following an operation performed on the prostate for cancer or for benign prostatic hyperplasia. Two adjustable balloons (one on each side of the urethra) are implanted to treat urinary stress incontinence.

The results will be analyzed to demonstrate the effects of the device as well as its associated risks. Therapeutic success will be based on whether patients demonstrate at least a 50% reduction in pad weight at 18 months follow-up compared to the pad weight results at baseline.


Condition Intervention Phase
Urinary Incontinence
Device: ProACT (Adjustable Continence Therapy)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Investigation of the ProACT Adjustable Continence Therapy for Treatment of Post-Prostatectomy Stress Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by Uromedica:

Primary Outcome Measures:
  • Primary Efficacy: Demonstrate the efficacy of the ProACT device in reducing incontinence as measured by the 24-hour pad weight at 18 months compared to baseline. A subject is a success if he demonstrates a 50% reduction. [ Time Frame: 6wk, 6 mo, 12 mo, 18 mo, 2 yr, annually after ] [ Designated as safety issue: No ]
    24 hour pad weight


Estimated Enrollment: 109
Study Start Date: August 2005
Estimated Study Completion Date: March 2013
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: ProACT (Adjustable Continence Therapy)
    Implantable device to reduce urinary stress incontinence
    Other Name: ProACT,Adjustable Incontinence therapy for Males
Detailed Description:

The study is a prospective, non-randomized multi-center investigation. Multiple measurements using 24 hour pad weight and pad count, validated questionnaires, voiding diaries will be used to evaluate the achievement of the study objectives. Subjects will be followed for a minimum of 18 months following implantation. Subjects will be requested to continue annual follow-ups through the FDA approval.

The purpose of the study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 109 male patients. The ProACT device is designed to treat men who have stress urinary incontinence arising from intrinsic sphincter deficiency following an operation performed on the prostate for cancer or for benign prostatic hyperplasia. Two adjustable balloons (one on each side of the urethra) are implanted to treat urinary stress incontinence.

The results will be analyzed to demonstrate the effects of the device as well as its associated risks. Therapeutic success will be based on whether patients demonstrate at least a 50% reduction in pad weight at 18 months follow-up compared to the pad weight results at baseline.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Undergone either a radical prostatectomy, transurethral resection of the prostate or other prostate surgery at least 12 months prior without radiation therapy
  • Demonstrate primary stress urinary incontinence
  • Male subjects at least 45 years of age
  • Willing and able to undergo surgical implantation of the ProACT devices
  • Willing and able to comply with the follow-up requirements
  • Willing and able to forego any other surgical urinary incontinence treatments while participating in the study
  • Willing and able to sign the informed consent
  • Positive 24 hour pad weight tests (greater than or equal to 8 gram pad weight increase demonstrated in two 24-hour pad weight tests)
  • Experiences at least 3 incontinence episodes per day during two baseline voiding diaries.
  • Negative Urine culture
  • No recurrent stricture at the anastamosis
  • No known urogenital malignancy other than previously treated prostate cancer
  • Physician determines subject to be suitable surgical candidate

Exclusion Criteria:

  • Primarily Urge incontinence
  • Detrusor instability or over-activity
  • Residual volume greater that 100 ml or greater than 25% of the total bladder capacity after voiding.
  • Subject has/had or is suspected of having bladder cancer
  • History of recurrent bladder stones
  • Neurogenic bladder that is atonic or has detrusor sphincter dyssynergia
  • Known hemophilia or a bleeding disorder
  • Abnormal PSA, according to sites laboratory standards, unless further investigation confirms no underlying prostate malignancy.
  • Known sever contrast solution allergy
  • Has a genitourinary mechanical prosthesis other than previous sling procedure (e.g., Artificial Urinary sphincter, implantable penile prosthesis)
  • Has a urethral stricture that prevents passage of an 18 F cystoscope or has had more than one urethrotomy
  • Undergone bulking procedure within 6 months of the baseline assessment
  • Subject is currently enrolled or plans to enroll in another device or drug clinical trial.
  • Subject is currently using an indwelling catheter or condom catheter for treatment of incontinence and is not willing to discontinue use at least 4 weeks prior to baseline assessment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00277095

Locations
United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724
United States, California
Kaiser Permanente-Los Angeles
Los Angeles, California, United States, 90027
United States, Florida
The Pelvic Clinic
Pembroke Pines, Florida, United States, 33028
Indian River Urology
Vero Beach, Florida, United States, 32960
United States, Illinois
Urological Surgeons
Kankakee, Illinois, United States, 60901
United States, Minnesota
Metro Urology
St. Paul, Minnesota, United States, 55102
United States, Missouri
Kansas City Urology Care
Kansas City, Missouri, United States, 64123
Canada, British Columbia
Can-Med Clinical Research Inc.
Victoria, British Columbia, Canada, V8T5G1
Canada, Quebec
CHUS-Fleurimont
Fleurimont, Quebec, Canada, J1H5N4
New Zealand
ProMed Urology
Tauranga, New Zealand
Sponsors and Collaborators
Uromedica
Investigators
Study Director: Tim Cook, Ph.D Uromedica, Inc.
  More Information

No publications provided

Responsible Party: Timothy C. Cook, PhD., Uromedica Inc.
ClinicalTrials.gov Identifier: NCT00277095     History of Changes
Other Study ID Numbers: UM02
Study First Received: January 11, 2006
Last Updated: June 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Uromedica:
Urinary Incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014