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ProACT Post-Approval Study

Primary Purpose

Stress Urinary Incontinence

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ProACT Adjustable Continence Therapy for Men

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Subject is a male of at least 50 years of age.
Subject demonstrates stress urinary incontinence.
Subject has undergone a radical prostatectomy, transurethral resection of the prostate, or other prostate surgery.
Subject is willing and able to undergo surgical implantation of ProACT devices.
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.
Subject is willing and able to sign the approved informed consent.
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).
Subject has a negative urine culture.
Subject has no known urogenital malignancy, other than previously treated prostate cancer.
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;
Physician determines subject to be a suitable surgical candidate.

Exclusion Criteria:

Subject has an existing urethral stricture, a history of any urethral strictures, or has ever had a urethrotomy.
Subject has undergone prostate surgery or any anti-incontinence surgery within the last 12 months.
Subject has an artificial urinary sphincter or any components of a previously implanted artificial urinary sphincter in vivo.
Subject has undergone radiation therapy in the prostatic area within the last 12 months.
Subject has untreated or unsuccessfully treated detrusor instability or over-activity.
Subject has an atonic bladder.
Subject had, presently has, or is suspected of having bladder cancer.
Subject has untreated or unsuccessfully treated bladder stones.
Subject has detrusor sphincter dyssynergia.
Subject has known hemophilia or a bleeding disorder.
Subject has a known severe contrast solution allergy (e.g., anaphylaxis, cardiac, or respiratory arrest).
Subject has insulin-dependent diabetes that is uncontrolled or not controllable, as indicated by an A1c test result of = 6.5%.

Sites / Locations

University of ColoradoRecruiting
University of FloridaRecruiting
Emory UniversityRecruiting
University of MichiganRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ProACT Adjustable Continence Therapy for Men

Arm Description

Patients implanted with ProACT Adjustable Continence Therapy for Men

Outcomes

Primary Outcome Measures

Urethral Strictures

Cumulative incidence of ProACT-related clinically relevant urethral strictures over 5 years of follow up.

Device Erosions

Cumulative incidence of ProACT device erosions over 5 years of follow-up.

Incontinence Quality of Life Questionnaire (I-QoL)

Results on Validated Incontinence Quality of Life Questionnaire

Secondary Outcome Measures

Full Information

NCT ID

NCT03767595

First Posted

December 4, 2018

Last Updated

May 19, 2023

Sponsor

Uromedica

1. Study Identification

Unique Protocol Identification Number

NCT03767595

Brief Title

ProACT Post-Approval Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 19, 2019 (Actual)

Primary Completion Date

September 1, 2025 (Anticipated)

Study Completion Date

September 1, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Uromedica

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress Urinary Incontinence

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

145 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ProACT Adjustable Continence Therapy for Men

Arm Type

Experimental

Arm Description

Patients implanted with ProACT Adjustable Continence Therapy for Men

Intervention Type

Device

Intervention Name(s)

ProACT Adjustable Continence Therapy for Men

Intervention Description

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.

Primary Outcome Measure Information:

Title

Urethral Strictures

Description

Cumulative incidence of ProACT-related clinically relevant urethral strictures over 5 years of follow up.

Time Frame

5 years

Title

Device Erosions

Description

Cumulative incidence of ProACT device erosions over 5 years of follow-up.

Time Frame

5 years

Title

Incontinence Quality of Life Questionnaire (I-QoL)

Description

Results on Validated Incontinence Quality of Life Questionnaire

Time Frame

5 years

Other Pre-specified Outcome Measures:

Title

Effect of ProACT on Subsequent Stress Urinary Incontinence(SUI) Therapy

Description

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.

Time Frame

5 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is a male of at least 50 years of age. Subject demonstrates stress urinary incontinence. Subject has undergone a radical prostatectomy, transurethral resection of the prostate, or other prostate surgery. Subject is willing and able to undergo surgical implantation of ProACT devices. 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. Subject is willing and able to sign the approved informed consent. 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). Subject has a negative urine culture. Subject has no known urogenital malignancy, other than previously treated prostate cancer. Subject meets ONE of the following criteria: Baseline Prostate-Specific Antigen (PSA) of less than or equal to 2.5ng/mL; 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; Physician determines subject to be a suitable surgical candidate. Exclusion Criteria: Subject has an existing urethral stricture, a history of any urethral strictures, or has ever had a urethrotomy. Subject has undergone prostate surgery or any anti-incontinence surgery within the last 12 months. Subject has an artificial urinary sphincter or any components of a previously implanted artificial urinary sphincter in vivo. Subject has undergone radiation therapy in the prostatic area within the last 12 months. Subject has untreated or unsuccessfully treated detrusor instability or over-activity. Subject has an atonic bladder. Subject had, presently has, or is suspected of having bladder cancer. Subject has untreated or unsuccessfully treated bladder stones. Subject has detrusor sphincter dyssynergia. Subject has known hemophilia or a bleeding disorder. Subject has a known severe contrast solution allergy (e.g., anaphylaxis, cardiac, or respiratory arrest). Subject has insulin-dependent diabetes that is uncontrolled or not controllable, as indicated by an A1c test result of = 6.5%.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Patrick Gora

Phone

7636949880

pgora@uromedica-inc.com

First Name & Middle Initial & Last Name or Official Title & Degree

Timothy C Cook, PhD

Phone

7636949880

regulatory@uromedica-inc.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Timothy C Cook, PhD

Organizational Affiliation

Uromedica, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

University of Colorado

City

Denver

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrea Pina

andrea.pinalimones@cuanschutz.edu

First Name & Middle Initial & Last Name & Degree

Brian Flynn, MD

First Name & Middle Initial & Last Name & Degree

Nate Coddington, MD

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

John Marks, DHSc, CCRP

Phone

352-273-5618

John.Marks@urology.ufl.edu

First Name & Middle Initial & Last Name & Degree

Lawrence Yeung, MD

Facility Name

Emory University

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sierra Williams

Phone

404-778-4729

sierra.williams@emory.edu

First Name & Middle Initial & Last Name & Degree

Lindsey Hartsell, MD

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nailah Henry

hnailah@med.umich.edu

First Name & Middle Initial & Last Name & Degree

Bahaa Malaeb, MD

12. IPD Sharing Statement

Learn more about this trial

ProACT Post-Approval Study

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