ProACT Therapy for the Treatment of Stress Urinary Incontinence in Males

Urinary Incontinence Clinical Trial

— ProACT  

Official title:

Clinical Investigation of the ProACT Adjustable Continence Therapy for Treatment of Post-Prostatectomy Stress Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00277095
• Other study ID #: UM02
• Status: Completed
• Phase: N/A
• Start date: August 2005
• Est. completion date: December 2017

Study information

• Verified date: April 2018
• Source: Uromedica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: December 2017
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years and older

Eligibility

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 (Prostate Specific Antigen), 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.

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• ProACT (Adjustable Continence Therapy)
Implantable device to reduce urinary stress incontinence

Locations

Country	Name	City	State
Canada	CHUS-Fleurimont	Fleurimont	Quebec
Canada	Can-Med Clinical Research Inc.	Victoria	British Columbia
New Zealand	Urology Bay of Plenty (formerly Promed Urology)	Tauranga
United States	Urological Surgeons	Kankakee	Illinois
United States	Kansas City Urology Care	Kansas City	Missouri
United States	Kaiser Permanente-Los Angeles	Los Angeles	California
United States	The Pelvic Clinic	Pembroke Pines	Florida
United States	Metro Urology	Saint Paul	Minnesota
United States	University of Arizona	Tucson	Arizona
United States	Indian River Urology	Vero Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Uromedica

Countries where clinical trial is conducted

United States,  Canada,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The percentage of participants with 50% reduction in pad weight.	18 month follow-up

External Links

•   ProACT Adjustable Continence for Men Premarket Approval (PMA) 11/24/2015