Adjustable Continence Therapy (ACT) for the Treatment of Female SUI

Not Applicable

Recruiting

• Conditions: Urinary Incontinence; Urinary Incontinence,Stress
• Interventions: Device: Adjustable Continence Therapy for Women (ACT)

• Registration Number: NCT04248283
• Lead Sponsor: Uromedica

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-27
• Study First Submitted QC: 2020-01-27
• Study First Posted: 2020-01-30
• Study Start: 2021-01-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 167

Inclusion Criteria

1. Female at least 22 years old
2. Diagnosed with stress urinary incontinence with primary Intrinsic Sphincter Deficiency
3. Provocative pad weight of greater than 11.0 grams
4. Candidate for surgical intervention
5. Negative urinalysis
6. Normal cystourethroscopy
7. Failed at least 6 months of previous treatment(s) for stress urinary incontinence (e.g., exercise regimen, electrical stimulation, surgical procedures, etc). Note: patients may have failed prior anti-incontinence procedures for SUI (e.g., suspension, sling, or urethral bulking agent)
8. Willing and able to sign informed consent and comply with trial follow-up requirements

Exclusion Criteria

1. Pregnant or lactating
2. Life expectancy of less than 5 years
3. Has uncontrolled diabetes as evidenced by HbA1c over 6.5% and fasting plasma glucose over 130 mg/dL
4. Has auto-immune disease
5. Undergoing radiation therapy
6. Active urinary tract infection
7. Detrusor instability refractory to medication
8. Reduced bladder compliance as defined by a cystometrogram
9. Significant residual volume (greater than 100 ml) after voiding in which detrusor contraction is weak, when the bladder volume is greater than or equal to 250 ml
10. Has, had, or is suspected of having bladder cancer
11. History of bladder stones
12. Urethral stricture evidenced during cystourethroscopy
13. Has a neurogenic bladder that is atonic or has detrusor sphincter dyssynergia
14. Has a diathesis, hemophilia, or a bleeding disorder
15. Has a rectocele, cystocele, urethrocele, enterocele, or pelvic prolapse of grade 3 or higher
16. Had prior pelvic radiotherapy
17. Had a prior artificial urinary sphincter implanted
18. Has a neurogenic condition known to affect bladder/sphincter function

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adjustable Continence Therapy for Women	Adjustable Continence Therapy for Women (ACT)	Implantation of the Adjustable Continence Therapy for the treatment of female SUI.

Primary Outcome Measures

Name	Time	Method
Provocative pad weight	12 months	Change in provocative pad weight from baseline

Secondary Outcome Measures

Name	Time	Method
Urogenital Distress Inventory (UDI)	12 months	Six item questionnaire. Scores range from 0-100. 0 being not distressed, 100 being very distressed.
Incontinence Quality of Life Questionnaire (I-QOL)	12 months	Twenty-two item questionnaire. Scores range from 0-100. 0 being lowest quality of life, 100 being highest quality of life.

Trial Locations

Locations (2)

CHI Health Research Center; 🇺🇸 Omaha, Nebraska, United States

University of Colorado; 🇺🇸 Denver, Colorado, United States