ACT for Stress Urinary Incontinence

Recruiting at 6 trial locations

Overseen By Colin Goudelocke

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Uromedica

Disqualifiers: Uncontrolled diabetes, Auto-immune disease, Neurogenic bladder, 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: 12 months

167 Participants Needed

Trial Summary

What is the purpose of this trial?

A prospective, single arm, non-randomized, multicenter, prospective case-series trial. The purpose of this trial is to demonstrate the safety and effectiveness of using the Adjustable Continence Therapy (ACT) to provide a clinically relevant improvement in stress urinary incontinence.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for guidance.

What data supports the effectiveness of the treatment Adjustable Continence Therapy for Stress Urinary Incontinence?

Research shows that Adjustable Continence Therapy (ACT) is effective for treating stress urinary incontinence in women, especially in cases where previous surgeries have failed or are not suitable. The treatment is minimally invasive and has been evaluated for its effectiveness and safety, with studies indicating positive outcomes in managing urinary incontinence. ^{1 2 3 4 5}

Is the Adjustable Continence Therapy (ACT) device safe for humans?

The Adjustable Continence Therapy (ACT) device has been studied for safety in treating stress urinary incontinence, with research indicating it is generally safe for both men and women, though some complications may occur. ^{1 2 5 6 7}

How is the Adjustable Continence Therapy (ACT) treatment different from other treatments for stress urinary incontinence?

The Adjustable Continence Therapy (ACT) is unique because it is a minimally invasive treatment that uses adjustable balloons to increase urethral coaptation (closure), making it suitable for women with stress urinary incontinence who have had unsuccessful previous surgeries or when traditional surgery is not ideal. ^{1 2 4 5 6}

Research Team

Timothy C Cook, PhD

Principal Investigator

Uromedica, Inc.

Eligibility Criteria

This trial is for women over 22 who've unsuccessfully tried other treatments for stress urinary incontinence (SUI) for at least 6 months. They should have a significant degree of urine leakage, as shown by a pad test, and be able to follow the trial's procedures. Women can't join if they're pregnant, breastfeeding, have certain bladder issues or cancers, severe pelvic prolapse, uncontrolled diabetes, bleeding disorders or are undergoing radiation therapy.

Inclusion Criteria

I have tried treatments for urinary incontinence for over 6 months without success.

You have leaked more than 11 grams of urine during a specific test.

Your cystourethroscopy results are normal.

Exclusion Criteria

Your bladder does not stretch like it should, as shown by a test called a cystometrogram.

I have or might have bladder cancer.

My bladder muscle is overactive and medications haven't helped.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Implantation of the Adjustable Continence Therapy for the treatment of female SUI

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Adjustable Continence Therapy for Women (ACT)

Trial Overview The Adjustable Continence Therapy (ACT) is being tested to see if it can significantly improve SUI in women. This single-arm study involves multiple centers where all participants receive ACT without being compared to another group.

Participant Groups

Group I: Adjustable Continence Therapy for Women Experimental Treatment 1 Intervention

Implantation of the Adjustable Continence Therapy for the treatment of female SUI.

Adjustable Continence Therapy for Women (ACT) is already approved in European Union, United States for the following indications:

Approved in European Union as ACT for:

• Stress Urinary Incontinence (SUI) in women

Approved in United States as Not FDA-approved for:

Who Is Running the Clinical Trial?

Uromedica

Lead Sponsor

Trials

4

Recruited

660+

Findings from Research

In a study involving 77 women with stress or mixed urinary incontinence, the adjustable continence therapy device (ACT) showed a 64% improvement rate, with 25% of patients achieving full continence after an average follow-up of 22 months.

The procedure had a 10% rate of peroperative complications and a 28% rate of explantations, indicating that while complications were manageable, a significant number of patients required device removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[ACT device: what place in the treatment of female urinary incontinence?]. Nacir, M., Ballanger, P., Donon, L., et al.[2013]

The Adjustable Continence Therapy (ACT) device significantly improved symptoms in at least 70% of patients with recurrent stress urinary incontinence, demonstrating its efficacy in a group of 49 patients who had previously failed other surgeries.

The procedure was relatively quick, averaging 20.3 minutes, and most patients (88%) received local or regional anesthesia, indicating a favorable safety profile; however, some complications were noted, including migration (12%) and erosion (4%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjustable continence therapy for treatment of recurrent female urinary incontinence. Kocjancic, E., Crivellaro, S., Smith, JJ., et al.[2016]

In a study of 67 women with urinary incontinence, over 90% showed improvement after receiving Adjustable Continence Therapy (ACT), with 60% maintaining satisfaction levels above 80% at the last follow-up, indicating its efficacy as a treatment option.

Despite a 37.3% rate of postoperative complications, the ACT procedure is considered beneficial due to its favorable benefit-risk ratio, especially for patients who cannot undergo or prefer not to have an artificial urinary sphincter.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adjustable Continence Therapy in women, middle term follow-up and a new technique for balloon positioning]. Vayleux, B., Luyckx, F., Thélu, S., et al.[2010]

Adjustable Continence Therapy (ACT) is a minimally invasive treatment for urinary incontinence in women, showing that 44% of participants became fully continent after the procedure, with a mean follow-up of 25 months across 41 women.

While ACT has potential benefits, it also has a complication rate of 39%, including issues like balloon migration and urinary obstruction, indicating that careful patient selection is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjustable continence therapy for female urinary incontinence: a minimally invasive option for difficult cases. Wachter, J., Henning, A., Roehlich, M., et al.[2014]

In a study of 281 women treated with ACT® balloons for stress urinary incontinence, 37% experienced complete success, while 33.5% showed improvement, indicating a promising short-term effectiveness for this treatment.

The procedure had a low rate of serious complications, with most being minor and manageable, suggesting that ACT® balloons are a safe and minimally invasive option for treating female stress urinary incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjustable Continence Therapy (ACT®) balloons to treat female stress urinary incontinence: effectiveness, safety and risk factors of failure and complication. de Guerry, ML., Demeestere, A., Bergot, C., et al.[2023]

The adjustable continence device (ProACT/ACT) significantly reduced urinary incontinence episodes from an average of 6.1 to 2.8 over a 48-month follow-up in 37 patients with neurogenic stress urinary incontinence.

The device is considered minimally invasive and safe, with 54.5% of patients reporting over 50% improvement in symptoms, making it a viable option for those not ready for more invasive surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of neurogenic stress urinary incontinence using an adjustable continence device: 4-year followup. Mehnert, U., Bastien, L., Denys, P., et al.[2012]

The Uromedica adjustable continence therapy device significantly improved symptoms of recurrent female stress urinary incontinence, with 76.4% of patients showing at least a one-grade improvement in the Stamey score after one year.

While 52% of patients were completely dry after one year, 24.4% experienced complications, mostly mild or moderate, and 18.3% required device explantation, indicating that while effective, careful monitoring is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The adjustable continence therapy system for recurrent female stress urinary incontinence: 1-year results of the North America Clinical Study Group. Aboseif, SR., Franke, EI., Nash, SD., et al.[2014]

References

1. France pubmed.ncbi.nlm.nih.gov

[ACT device: what place in the treatment of female urinary incontinence?]. [2013]

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

Adjustable continence therapy for treatment of recurrent female urinary incontinence. [2016]

3. France pubmed.ncbi.nlm.nih.gov

[Adjustable Continence Therapy in women, middle term follow-up and a new technique for balloon positioning]. [2010]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Adjustable continence therapy for female urinary incontinence: a minimally invasive option for difficult cases. [2014]

5. England pubmed.ncbi.nlm.nih.gov

Adjustable Continence Therapy (ACT®) balloons to treat female stress urinary incontinence: effectiveness, safety and risk factors of failure and complication. [2023]

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

Treatment of neurogenic stress urinary incontinence using an adjustable continence device: 4-year followup. [2012]

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

The adjustable continence therapy system for recurrent female stress urinary incontinence: 1-year results of the North America Clinical Study Group. [2014]