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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Adjustable Continence Therapy (ACT) to determine its effectiveness for women with stress urinary incontinence, a condition where sneezing or laughing can cause leaks. The trial aims to demonstrate that ACT is safe and can improve this condition. Women who may qualify for the trial have experienced stress urinary incontinence due to a specific issue with their bladder's sphincter muscle, have tried other treatments for at least six months without success, and are considering surgery. As an unphased trial, this study provides a unique opportunity for participants to contribute to groundbreaking research that could lead to new treatment options.

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 prior data suggests that the Adjustable Continence Therapy is safe for women?

Research shows that the Adjustable Continence Therapy (ACT) for women is generally easy to handle. Studies of similar treatments have demonstrated a noticeable improvement in quality of life related to incontinence. For instance, the average number of pads used daily decreased from 4.0 to fewer over time.

Reports indicate that the benefits of the ACT device usually outweigh the risks. While no treatment is without possible side effects, safety data suggest that negative effects are rare and typically mild. Approval of the device for other conditions signals its safety.

Overall, existing evidence suggests that ACT is a promising and safe option for treating stress urinary incontinence in women. However, discussing any concerns with a healthcare professional before joining a trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Adjustable Continence Therapy (ACT) for Stress Urinary Incontinence because it offers a novel approach to managing this condition. Unlike traditional options like pelvic floor exercises, medications, or surgical interventions, ACT involves the implantation of an adjustable device. This device can be tailored to the individual needs of each patient, potentially leading to more effective and personalized management of symptoms. Moreover, the adjustability aspect may reduce the need for additional surgeries, making it a less invasive long-term solution.

What evidence suggests that the Adjustable Continence Therapy is effective for stress urinary incontinence?

Research shows that Adjustable Continence Therapy (ACT), the treatment under study in this trial, can greatly help women with stress urinary incontinence. Studies have found that most women using ACT reduce their daily pad use by half or more, experiencing less leakage. About two-thirds of women report a clear improvement in their symptoms. Additionally, quality of life scores improved from 36.5 to 70.7, indicating that ACT significantly enhances everyday life. The treatment is simple, safe, and involves only a minor procedure, making it a promising option for managing this condition. ^{1 6 7 8 9}

Who Is on the Research Team?

Timothy C Cook, PhD

Principal Investigator

Uromedica, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04248283

Adjustable Continence Therapy (ACT) for the Treatment of ... The purpose of this trial is to demonstrate the safety and effectiveness of using the Adjustable Continence Therapy (ACT) to provide a clinically relevant ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6850145/

Outcome and complications of adjustable continence ... The majority of our study population reported improvement on their condition and greater than or equal to 50% reduction in daily pad use. Keywords: minimally ...

3. karger.com karger.com/uin/article/107/7/653/844602/Adjustable-Continence-Therapy-Balloons-in-Female

Adjustable Continence Therapy Balloons in Female ... The ACT® balloons technique is simple and results in symptomatic improvement in two-thirds of female patients with SUI related to ISD. However, ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022534709000615

The Adjustable Continence Therapy System for Recurrent ... Improvement in the mean incontinence quality of life questionnaire score was noted at 36.5 to 70.7 (p <0.001). Reductions in mean Urogenital Distress Inventory ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20959993/

Treatment of moderate to severe female stress urinary ... The ACT device is an effective, simple, safe, and minimally invasive treatment for moderate to severe recurrent female stress urinary incontinence after ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31429982/

Adjustable continence therapy (ProACT) for the treatment ... ProACT implantation resulted in an incontinence QOL improvement of 30.8 points from baseline. At baseline, patients on average were using 4.0 pads per day (PPD) ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf13/P130018B.pdf

summary of safety and effectiveness data (ssed) In conclusion, given the available information summarized above, the probable benefits outweigh the probable risks for the intended use of the ProACT Adjustable ...

8. uromedica-inc.com uromedica-inc.com/proact

ProACT Adjustable Continence Therapy for Men Efficacy and safety of adjustable balloons (Proact™) to treat male stress urinary incontinence after prostate surgery: Medium and long‐term follow‐up data ...

9. ics.org ics.org/2023/abstract/493

Adjustable continence Therapy for treatment of stress urinary ... This study reports a large cohort of both neurogenic and non-neurogenic patients, male and female, adjustable continence therapy implantation. It has been able ...