Status:
COMPLETED
ProACT Therapy for the Treatment of Stress Urinary Incontinence in Males
Lead Sponsor:
Uromedica
Conditions:
Urinary Incontinence
Eligibility:
MALE
45+ years
Phase:
NA
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 u...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT00277095
Start Date
August 1 2005
End Date
December 1 2017
Last Update
May 31 2018
Active Locations (10)
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1
University of Arizona
Tucson, Arizona, United States, 85724
2
Kaiser Permanente-Los Angeles
Los Angeles, California, United States, 90027
3
The Pelvic Clinic
Pembroke Pines, Florida, United States, 33028
4
Indian River Urology
Vero Beach, Florida, United States, 32960