Clinical trial NCT04248283: Adjustable Continence Therapy (ACT) for the Treatment of Female SUI
Official title: A Clinical Investigation of the Adjustable Continence Therapy (ACT) for Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Incontinence
Urinary Incontinence,Stress
Keywords: Urinary Incontinence
Urination Disorders
Urination Involuntary
Urologic Diseases
Lower Urinary Tract Symptoms
Lead sponsor: Uromedica
Sponsor class: INDUSTRY
First posted: 2020-01-30
Enrollment: 167
Sex: FEMALE
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective, single arm, non-randomized, multicenter, prospective case-series trial.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Provocative pad weight
timeFrame: 12 months
Secondary outcomes:
measure: Urogenital Distress Inventory (UDI)
timeFrame: 12 months
measure: Incontinence Quality of Life Questionnaire (I-QOL)
timeFrame: 12 months
Other outcomes:
measure: Complete adverse event profile
timeFrame: 12 months
Locations:
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Omaha
country: United States
facility: CHI Health Research Center
state: Nebraska
Study officials:
affiliation: Uromedica, Inc.
name: Timothy C Cook, PhD
role: STUDY_DIRECTOR
References: