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Device

ACT 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
Female at least 22 years old
Diagnosed with stress urinary incontinence with primary Intrinsic Sphincter Deficiency
Must not have
Has, had, or is suspected of having bladder cancer
Detrusor instability refractory to medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will show whether the ACT is safe and effective in improving stress urinary incontinence.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include discomfort at the implant site, infection risk from surgery, potential device malfunction or failure leading to persistent symptoms of SUI.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged 22 or older.
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I have been diagnosed with stress urinary incontinence due to weak sphincter muscles.
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I am eligible for surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or might have bladder cancer.
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My bladder muscle is overactive and medications haven't helped.
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I have had bladder stones in the past.
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My diabetes is not under control, with high HbA1c and blood sugar levels.
Select...
I am currently receiving radiation therapy.
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I have had radiation therapy to my pelvic area before.
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I have a bleeding disorder.
Select...
I currently have a urinary tract infection.
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I have trouble fully emptying my bladder, leaving more than 100 ml.
Select...
I have a narrowed urethra confirmed by a bladder scope test.
Select...
I have a nerve condition that affects my bladder control.
Select...
My bladder doesn't contract properly or has coordination issues.
Select...
I have a significant pelvic organ prolapse.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Provocative pad weight
Secondary study objectives
Incontinence Quality of Life Questionnaire (I-QOL)
Urogenital Distress Inventory (UDI)
Other study objectives
Complete adverse event profile

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: Adjustable Continence Therapy for WomenExperimental Treatment1 Intervention
Implantation of the Adjustable Continence Therapy for the treatment of female SUI.

Find a Location

Who is running the clinical trial?

UromedicaLead Sponsor
3 Previous Clinical Trials
489 Total Patients Enrolled
Timothy C Cook, PhDStudy DirectorUromedica, Inc.
1 Previous Clinical Trials
145 Total Patients Enrolled

Media Library

Adjustable Continence Therapy for Women (ACT) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04248283 — N/A
Stress Incontinence Research Study Groups: Adjustable Continence Therapy for Women
Stress Incontinence Clinical Trial 2023: Adjustable Continence Therapy for Women (ACT) Highlights & Side Effects. Trial Name: NCT04248283 — N/A
Adjustable Continence Therapy for Women (ACT) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04248283 — N/A
~27 spots leftby Sep 2025
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