ProACT Therapy for Stress Urinary Incontinence

Recruiting at 6 trial locations

Overseen By Lawrence Yeung, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Uromedica

Disqualifiers: Urethral stricture, Bladder cancer, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Implantation procedure

145 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is the ProACT treatment different from other treatments for stress urinary incontinence?

The ProACT treatment is unique because it involves the use of adjustable balloons placed near the bladder neck, which can be adjusted without further surgery to improve continence. This minimally invasive approach allows for personalized adjustments to better manage stress urinary incontinence in men, especially after prostate surgery. ^{1 2 3 4 5}

What data supports the effectiveness of the ProACT treatment for stress urinary incontinence?

Research shows that the ProACT treatment, which involves adjustable balloons to help control urine flow, is effective for men with stress urinary incontinence after prostate surgery. Studies indicate it is safe and can be adjusted to improve continence (control over urination) over time. ^{1 2 3 4 5}

Who Is on the Research Team?

Timothy C Cook, PhD

Principal Investigator

Uromedica, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have had surgery for prostate cancer.

Subject is willing and able to sign the approved informed consent

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

Exclusion Criteria

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

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

I have bladder and sphincter muscle coordination issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are implanted with ProACT Adjustable Continence Therapy for Men

Implantation procedure

Follow-up

Participants are monitored for urethral stricture, device erosion, and quality of life over 5 years

5 years

What Are the Treatments Tested in This Trial?

Interventions

• ProACT Adjustable Continence Therapy for Men

Trial Overview 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.

How Is the Trial Designed?

Group I: ProACT Adjustable Continence Therapy for Men Experimental Treatment 1 Intervention

Patients implanted with ProACT Adjustable Continence Therapy for Men

ProACT Adjustable Continence Therapy for Men is already approved in United States, European Union for the following indications:

Approved in United States as ProACT Adjustable Continence Therapy for Men for:

• Stress urinary incontinence arising from intrinsic sphincter deficiency of at least twelve months duration following radical prostatectomy or transurethral resection of the prostate (TURP) and who have failed to respond adequately to conservative therapy

Approved in European Union as ProACT Adjustable Continence Therapy for Men for:

• Stress urinary incontinence arising from intrinsic sphincter deficiency following radical prostatectomy or transurethral resection of the prostate (TURP)

Who Is Running the Clinical Trial?

Uromedica

Lead Sponsor

Trials

4

Recruited

660+

Published Research Related to This Trial

The ProACT™ adjustable continence therapy showed a 40.1% overall success rate in treating male stress urinary incontinence after radical prostatectomy, with a median patient impression of improvement (PII) score of 18.3%.

For patients who still had the ProACT™ device in place, the success and improvement rate was significantly higher at 78%, indicating that the therapy can be effective, especially when the device is retained.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjustable continence balloons in postprostatectomy incontinence: Outcomes and complications. Ricard, H., Léon, G., Branchereau, J., et al.[2022]

The ProACT device significantly reduced urinary incontinence in 64 men after prostate surgery, with median daily pad usage dropping from 5.2 at baseline to 1.54 at 12 months, and 67% of patients considered dry postoperatively.

The device showed a good safety profile, with a 14% rate of device removal due to complications, which were manageable and allowed for further treatment options, indicating it is a viable option for men with stress urinary incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjustable Continence Therapy for the treatment of male stress urinary incontinence: a single-centre study. Kocjancic, E., Crivellaro, S., Ranzoni, S., et al.[2015]

The Adjustable Continence Therapy (ProACT) device significantly reduced daily pad usage for urinary incontinence from an average of 4.6 pads to 1.06 pads per day over 12 months, indicating its efficacy in treating postprostatectomy stress urinary incontinence.

The procedure was safe and technically feasible, with 88% of patients requiring adjustments to optimize the device, although complications occurred in 19 patients, primarily within the first month post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of postprostatectomy stress urinary incontinence using a minimally invasive adjustable continence balloon device, ProACT: results of a preliminary, multicenter, pilot study. Lebret, T., Cour, F., Benchetrit, J., et al.[2008]

The implantation of adjustable balloon devices (ProACT) significantly improved quality of life for men with stress urinary incontinence (SUI), with an average improvement of 30.8 points and a reduction in pad usage from 4.0 pads per day to 1.1 pads per day after treatment.

In a review of 19 studies involving 1264 patients over an average follow-up of 3.6 years, 60.2% of patients were considered 'dry' post-implantation, and 81.9% experienced either dryness or significant improvement, indicating that this treatment is both effective and safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjustable continence therapy (ProACT) for the treatment of male stress urinary incontinence: A systematic review and meta-analysis. Larson, T., Jhaveri, H., Yeung, LL.[2020]

The adjustable continence therapy (ProACT) device significantly reduced pad usage for male stress urinary incontinence, with 80% of the last 50 patients achieving dryness or significant improvement compared to 60% in the first 50 patients.

Improvements in incontinence quality of life (I-QOL) were more pronounced in the latter group, indicating that advancements in the surgical technique led to better patient outcomes and fewer complications, with the procedure now being performed in over 100 centers across Europe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjustable continence therapy (ProACT): evolution of the surgical technique and comparison of the original 50 patients with the most recent 50 patients at a single centre. Hübner, WA., Schlarp, OM.[2019]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Adjustable continence balloons in postprostatectomy incontinence: Outcomes and complications. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Adjustable Continence Therapy for the treatment of male stress urinary incontinence: a single-centre study. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Treatment of postprostatectomy stress urinary incontinence using a minimally invasive adjustable continence balloon device, ProACT: results of a preliminary, multicenter, pilot study. [2008]

4. United States pubmed.ncbi.nlm.nih.gov

Adjustable continence therapy (ProACT) for the treatment of male stress urinary incontinence: A systematic review and meta-analysis. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Adjustable continence therapy (ProACT): evolution of the surgical technique and comparison of the original 50 patients with the most recent 50 patients at a single centre. [2019]