Urinary Incontinence, Urinary Incontinence,Stress
Conditions
Keywords
Urinary Incontinence, Urination Disorders, Urination Involuntary, Urologic Diseases, Lower Urinary Tract Symptoms
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.
Interventions
DEVICEAdjustable 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).
Sponsors
Uromedica
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A prospective, single arm, non-randomized, multicenter, prospective case-series trial.
Eligibility
Sex/Gender
FEMALE
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Provocative pad weight | 12 months | Change in provocative pad weight from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France, United States
Contacts
CONTACTLisa Draper
CONTACTMatt Kelly, PhD
STUDY_DIRECTORPhilip Johnson, PhD
Uromedica, Inc.
Outcome results
None listed