ProACT Therapy for the Treatment of Stress Urinary Incontinence in Males

NCT00277095 | Completed Results

• 1 other identifier: UM02
• Study Type: interventional
• Target: 123
• Locations: 3 countries
• Sites: 10

Brief 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.

Conditions

Urinary Incontinence

Keywords

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

ProACT (Adjustable Continence Therapy)

EXPERIMENTAL

Implantation with ProACT (Adjustable Continence Therapy), Single Arm

Device: ProACT (Adjustable Continence Therapy)

Interventions

ProACT (Adjustable Continence Therapy) DEVICE

Implantable device to reduce urinary stress incontinence

Also known as: ProACT,Adjustable Incontinence therapy for Males

ProACT (Adjustable Continence Therapy)

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uromedica: lead

Study Sites (10)

University of Arizona

Tucson, Arizona, 85724, United States

Location

Kaiser Permanente-Los Angeles

Los Angeles, California, 90027, United States

Location

The Pelvic Clinic

Pembroke Pines, Florida, 33028, United States

Location

Indian River Urology

Vero Beach, Florida, 32960, United States

Location

Urological Surgeons

Kankakee, Illinois, 60901, United States

Location

Metro Urology

Saint Paul, Minnesota, 55102, United States

Location

Kansas City Urology Care

Kansas City, Missouri, 64123, United States

Location

Can-Med Clinical Research Inc.

Victoria, British Columbia, V8T5G1, Canada

Location

CHUS-Fleurimont

Fleurimont, Quebec, J1H5N4, Canada

Location

Urology Bay of Plenty (formerly Promed Urology)

Tauranga, New Zealand

Location

Related Links

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

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Sabitha R Shriram
• Organization: Uromedica

sshriram@uromedica-inc.com

763-694-9880

Study Officials

• Tim Cook, Ph.D

  Uromedica, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2006
• First Posted: January 13, 2006
• Study Start: August 1, 2005
• Primary Completion: February 1, 2009
• Study Completion: December 1, 2017
• Last Updated: May 31, 2018
• Results First Posted: February 3, 2016

Record last verified: 2018-04

Locations

US (7); CA (2); NZ (1)