N/A
N=221
Adjustable Continence Therapy (ACT) Device for the Treatment of Female Stress Urinary Incontinence
Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT00113555 ↗Enrolled (actual)
221
Serious AEs
1.2%
Results posted
Jun 2018
Primary outcome: Primary: Change of Stamey Grade From Baseline to 12 Months. — -1.17 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ACT (Adjustable Continence Therapy) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Uromedica
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Stamey Grade From Baseline to 12 Months. |
-1.17 | <0.001 sig |
| SECONDARY Incontinence Quality of Life (IQoL) Questionnaire |
28.63 | — |
| SECONDARY Incontinence Impact Questionnaire (IIQ-7) |
-26.53 | — |
| SECONDARY Urinary Distress Inventory (UDI-6) |
-22.66 | — |
| SECONDARY Number of Incontinence Episodes Per Day (Voiding Diary) |
-2.76 | — |
| SECONDARY Number of Pads Changed Per Day (Voiding Diary) |
-1.59 | — |
| SECONDARY Provocative Pad Weight |
-31.03 | — |
Summary
The purpose of this study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 160 implanted female patients in which two adjustable balloons (one on each side of the urethra) are implanted to treat urinary stress incontinence.
The results will be analyzed to demonstrate the effects of the device as well as its associated risks. Therapeutic success will be based on whether the patients demonstrate at least a one-grade (mean) reduction in the Stamey score at 12 months.
Eligibility Criteria
Inclusion Criteria
- Women
- 18 years or older
- Diagnosed with stress urinary incontinence with or without urethral hypermobility
- Willing to sign informed consent
- Candidates for surgical intervention for stress incontinence
- Negative urinalysis or urine culture within 2 weeks of implantation
- Normal cystourethroscopy
- Failed at least 6 months of previous treatments for stress urinary incontinence (e.g., exercise regimen, electrical stimulation, surgical procedures, etc.)
- May have failed suspension or sling procedures
Exclusion Criteria
- Pregnant or lactating
- Life expectancy of less than one year
- Insulin dependant diabetic
- Auto-immune disease
- Undergoing radiation therapy
- Active urinary tract infection
- Detrusor instability refractory to meds
- Reduced bladder compliance
- Significant bladder residual >100mls
- Bladder cancer
- Unsuccessfully treated bladder stones
- Current urethral stricture preventing the passage of a 24 French endoscope
- Neurogenic bladder
- Uncorrected rectocele, cystocele, urethrocele, enterocele or pelvic prolapse of Grade 3 or higher
- Prior pelvic radiotherapy
- Artificial urinary sphincter implanted
Data sourced from ClinicalTrials.gov (NCT00113555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.