Adjustable Continence Therapy (ACT) for the Treatment of Female SUI
NCT ID: NCT04248283
Last Updated: 2024-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
167 participants
INTERVENTIONAL
2021-01-26
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Adjustable Continence Therapy for Women
Implantation of the Adjustable Continence Therapy for the treatment of female SUI.
Adjustable Continence Therapy for Women (ACT)
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).
Interventions
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Adjustable Continence Therapy for Women (ACT)
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
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Inclusion Criteria
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
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
22 Years
FEMALE
No
Sponsors
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Uromedica
INDUSTRY
Responsible Party
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Principal Investigators
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Timothy C Cook, PhD
Role: STUDY_DIRECTOR
Uromedica, Inc.
Locations
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University of Colorado
Denver, Colorado, United States
CHI Health Research Center
Omaha, Nebraska, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UM08
Identifier Type: -
Identifier Source: org_study_id
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