ProACT Therapy for the Treatment of Stress Urinary Incontinence in Males - Full Text View

Sponsored by:	Uromedica
Information provided by:	Uromedica
ClinicalTrials.gov Identifier:	NCT00277095

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 II Phase III

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Clinical Investigation of the ProACT Adjustable Continence Therapy for Treatment of Post-Prostatectomy Stress Urinary Incontinence

Further study details as provided by Uromedica:

Primary Outcome Measures:

Primary Safety: Characterize the frequency of complications that occur among subjects implanted with the ProACT system fro implant through the 18 month follow-up.
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.

Secondary Outcome Measures:

Characterize the frequency and severity of all adverse events; Assess changes in bladder function using urodynamics; Reduction in the number of pads use to manage incontinence

Estimated Enrollment:	109
Study Start Date:	August 2005
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

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

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, PHD

Uromedica, Inc.

More Information

No publications provided

Responsible Party:	Uromedica Inc. ( Diane Burnside, Clinical Director )
Study ID Numbers:	UM02
Study First Received:	January 11, 2006
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00277095 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Uromedica:

Urinary Incontinence

Study placed in the following topic categories:

Signs and Symptoms
Urinary Incontinence, Stress
Urologic Diseases

Urination Disorders
Stress
Urinary Incontinence

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Urinary Incontinence, Stress

Urologic Diseases
Urination Disorders
Urinary Incontinence

ClinicalTrials.gov processed this record on May 07, 2009