Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2025-12-24 @ 1:50 PM
NCT ID:
NCT00277095
Eligibility 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 (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.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
45 Years
Study:
NCT00277095
Study Brief:
Protocol Section:
NCT00277095