Adjustable Continence Therapy (ACT) for the Treatment of Female SUI
A Clinical Investigation of the Adjustable Continence Therapy (ACT) for Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency
1 other identifier
interventional
167
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2020
CompletedFirst Posted
Study publicly available on registry
January 30, 2020
CompletedStudy Start
First participant enrolled
January 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedJuly 23, 2024
July 1, 2024
4.7 years
January 27, 2020
July 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Provocative pad weight
Change in provocative pad weight from baseline
12 months
Secondary Outcomes (2)
Urogenital Distress Inventory (UDI)
12 months
Incontinence Quality of Life Questionnaire (I-QOL)
12 months
Other Outcomes (1)
Complete adverse event profile
12 months
Study Arms (1)
Adjustable Continence Therapy for Women
EXPERIMENTALImplantation of the Adjustable Continence Therapy for the treatment of female SUI.
Interventions
Two ACT devices are implanted in each patient. The devices are intended for implantation in the paraurethral space, with the balloons located on each side of the urethra near the bladder neck. The ports are placed subcutaneously in the labia majora. The balloons are filled after implantation with an isotonic solution via needle injection into the port. The ACT implant can be placed using local, spinal or general anesthesia with the surgical instruments (provided separately).
Eligibility Criteria
You may qualify if:
- Female at least 22 years old
- Diagnosed with stress urinary incontinence with primary Intrinsic Sphincter Deficiency
- Provocative pad weight of greater than 11.0 grams
- Candidate for surgical intervention
- Negative urinalysis
- Normal cystourethroscopy
- 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)
- Willing and able to sign informed consent and comply with trial follow-up requirements
You may not qualify if:
- Pregnant or lactating
- Life expectancy of less than 5 years
- Has uncontrolled diabetes as evidenced by HbA1c over 6.5% and fasting plasma glucose over 130 mg/dL
- Has auto-immune disease
- Undergoing radiation therapy
- Active urinary tract infection
- Detrusor instability refractory to medication
- Reduced bladder compliance as defined by a cystometrogram
- 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
- Has, had, or is suspected of having bladder cancer
- History of bladder stones
- Urethral stricture evidenced during cystourethroscopy
- Has a neurogenic bladder that is atonic or has detrusor sphincter dyssynergia
- Has a diathesis, hemophilia, or a bleeding disorder
- Has a rectocele, cystocele, urethrocele, enterocele, or pelvic prolapse of grade 3 or higher
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uromedicalead
Study Sites (2)
University of Colorado
Denver, Colorado, 80045, United States
CHI Health Research Center
Omaha, Nebraska, 68124, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Timothy C Cook, PhD
Uromedica, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2020
First Posted
January 30, 2020
Study Start
January 26, 2021
Primary Completion
September 30, 2025
Study Completion
December 30, 2025
Last Updated
July 23, 2024
Record last verified: 2024-07