ProACT Post-Approval Study

Stress Urinary Incontinence Clinical Trial

Official title:

Post Approval Study of the ProACT™ Adjustable Continence Therapy for Men

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03767595
• Other study ID #: PAS001
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2019
• Est. completion date: September 1, 2030

Study information

• Verified date: May 2023
• Source: Uromedica
• Contact: Patrick Gora
• Phone: 7636949880
• Email: pgora[@]uromedica-inc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The ProACT Post Approval Study is a 5-year prospective, open-label, multi-center study designed to evaluate the long-term incidence of urethral stricture and device erosion after ProACT implantation. In addition, the study will evaluate whether treatment with ProACT affects clinical outcomes after subsequent SUI therapies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 145
• Est. completion date: September 1, 2030
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Subject is a male of at least 50 years of age.

2. Subject demonstrates stress urinary incontinence.

3. Subject has undergone a radical prostatectomy, transurethral resection of the prostate, or other prostate surgery.

4. Subject is willing and able to undergo surgical implantation of ProACT devices.

5. Subject is willing and able to comply with study-required

follow-up activities, including annual telephonic follow -up interviews, for a period of 5 years from their date of initial implantation. This includes compliance even after possible explant of ProACT devices and/or possible implantation of subsequent therapies.

6. Subject is willing and able to sign the approved informed consent.

7. Subject has two positive 24-hour pad weight tests (greater than or equal to 8 gram pad weight increase demonstrated in two 24-hour pad weight tests).

8. Subject has a negative urine culture.

9. Subject has no known urogenital malignancy, other than previously treated prostate cancer.

10. Subject meets ONE of the following criteria:

1. Baseline Prostate-Specific Antigen (PSA) of less than or equal to 2.5ng/mL;

2. Baseline PSA > 2.5ng/mL and less than or equal to 10 ng/mL AND free PSA greater than or equal to 25% of total PSA;

11. Physician determines subject to be a suitable surgical candidate.

Exclusion Criteria:

1. Subject has an existing urethral stricture, a history of any urethral strictures, or has ever had a urethrotomy.

2. Subject has undergone prostate surgery or any anti-incontinence surgery within the last 12 months.

3. Subject has an artificial urinary sphincter or any components of a previously implanted artificial urinary sphincter in vivo.

4. Subject has undergone radiation therapy in the prostatic area within the last 12 months.

5. Subject has untreated or unsuccessfully treated detrusor instability or over-activity.

6. Subject has an atonic bladder.

7. Subject had, presently has, or is suspected of having bladder cancer.

8. Subject has untreated or unsuccessfully treated bladder stones.

9. Subject has detrusor sphincter dyssynergia.

10. Subject has known hemophilia or a bleeding disorder.

11. Subject has a known severe contrast solution allergy (e.g., anaphylaxis, cardiac, or respiratory arrest).

12. Subject has insulin-dependent diabetes that is uncontrolled or not controllable, as indicated by an A1c test result of = 6.5%.

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• ProACT Adjustable Continence Therapy for Men
The ProACT therapy consists of two small, adjustable silicone balloons connected with tubing to a port. During a minimally invasive outpatient procedure, the balloons are surgically placed in the area where the prostate was removed or resected.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	University of Colorado	Denver	Colorado
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Uromedica

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effect of ProACT on Subsequent Stress Urinary Incontinence(SUI) Therapy	This data will be collected with a "Post ProACT Explant Subsequent Therapy Questionnaire".; This questionnaire will ask 3 questions regarding the ProACT therapy; Did the ProACT therapy have a detrimental effect on the difficulty of the subsequent implant surgery?; Did the ProACT therapy significantly increase the time required to implant the subsequent implant surgery?; Did the ProACT therapy increase the surgical complication rate during the subsequent implant surgery?; The scale for each question is 0-1. 0 Meaning no effect (a "No" response on the questionnaire) and 1 being some effect ("Yes" response on the questionnaire). No effect (0) on subsequent SUI therapies is the better outcome.	5 years
Primary	Urethral Strictures	Cumulative incidence of ProACT-related clinically relevant urethral strictures over 5 years of follow up.	5 years
Primary	Device Erosions	Cumulative incidence of ProACT device erosions over 5 years of follow-up.	5 years
Primary	Incontinence Quality of Life Questionnaire (I-QoL)	Results on Validated Incontinence Quality of Life Questionnaire	5 years