What side effects are associated with this type of intervention?

Common treatments for stress incontinence, such as the ProACT (Adjustable Continence Therapy), often involve surgical implantation of devices to support the urethra. Known side effects include urethral stricture, device erosion, infection, pain, and urinary retention. Patients may also experience discomfort or complications related to the surgical procedure.

What prior FDA approvals exist?

The ProACT (Adjustable Continence Therapy) is a device-based treatment for stress urinary incontinence. Similar FDA-approved treatments include the use of urethral slings and bulking agents. Urethral slings, such as the Tension-free Vaginal Tape (TVT) and Transobturator Tape (TOT), have been widely used and approved for providing support to the urethra. Bulking agents like collagen and carbon-coated beads are injected into the urethral tissue to improve closure. These treatments aim to enhance urethral support and function, similar to the mechanism of the ProACT device.

What other types of research exist?

Promising novel alternatives to ProACT for stress urinary incontinence in 2024 include: 1) Bulkamid, a urethral bulking agent that has shown positive results in clinical trials for SUI. 2) The ATOMS (Adjustable Transobturator Male System) device, which provides adjustable support for the urethra. 3) Stem cell therapy, which is being explored for its potential to regenerate and strengthen the urethral sphincter. 4) Magnetic stimulation therapy, which uses magnetic fields to strengthen pelvic floor muscles and improve continence.

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Adjustable Continence Device

ProACT Therapy for Stress Urinary Incontinence

N/A

Recruiting

Research Sponsored by Uromedica

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the effects of the ProACT device, which is implanted to help people with stress urinary incontinence (SUI). The device provides extra support to the urethra to prevent accidental urine leakage. The study will also look at how well patients do with other SUI treatments after having the ProACT device. The ProACT device is a minimally invasive treatment for male stress urinary incontinence, often used after prostate surgery, and involves the implantation of adjustable balloons to support the urethra.

Who is the study for?

Men over 50 with stress urinary incontinence post-prostate surgery can join this study. They must be able to undergo ProACT device implantation, follow a 5-year study plan including phone interviews, and have no untreated urogenital cancers or bladder conditions. Men with severe allergies, uncontrolled diabetes (A1c >6.5%), recent prostate/anti-incontinence surgeries, or radiation therapy are excluded.

What is being tested?

The trial is testing the long-term safety of ProACT Adjustable Continence Therapy for men with urinary incontinence after prostate surgery. It focuses on risks like urethral stricture and device erosion over five years and how it affects future treatments for stress urinary incontinence.

What are the potential side effects?

Potential side effects may include complications such as urethral stricture (narrowing of the urethra) and device erosion into surrounding tissues which could require additional medical attention or surgical intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had surgery for prostate cancer.

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I am willing and able to have surgery to implant ProACT devices.

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I have no urogenital cancer except for treated prostate cancer.

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I experience urine leakage when I cough, sneeze, or exercise.

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I am a man aged 50 or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My diabetes is not under control, with an A1c level of 6.5% or higher.

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I have bladder control issues that haven't improved with treatment.

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I have bladder and sphincter muscle coordination issues.

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I have or might have bladder cancer.

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I have bladder stones that haven't been treated or treatments failed.

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I have a bladder that cannot contract.

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I have had radiation therapy in the prostate area within the last year.

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I have or had a narrowed urethra or underwent a procedure to widen it.

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I have hemophilia or another bleeding disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Device Erosions

Incontinence Quality of Life Questionnaire (I-QoL)

Urethral Strictures

Other study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ProACT Adjustable Continence Therapy for MenExperimental Treatment1 Intervention

Patients implanted with ProACT Adjustable Continence Therapy for Men

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Stress Incontinence is commonly treated with methods that enhance urethral support and increase resistance to urine flow. Treatments like the ProACT (Adjustable Continence Therapy) involve the implantation of adjustable balloons near the bladder neck, which can be inflated or deflated to provide the necessary support to the urethra. This mechanism helps to prevent urine leakage during activities that increase abdominal pressure, such as coughing or exercising. The ability to adjust the balloons post-implantation allows for personalized treatment, improving patient outcomes and comfort. This matters for Stress Incontinence patients as it offers a minimally invasive option with the flexibility to tailor the support to individual needs, potentially reducing the need for more invasive surgical procedures.