Stress Urinary incontinence
Conditions
Interventions
N.A.
Sponsors
Solace Therapeutics, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Has the patient signed a written informed consent form? 2. Is the patient a female 18 years of age or older with stress urinary incontinence that has been documented by visual confirmation of the leakage during stress maneuvers? 3. Has the patient experienced SUI for at least 12 months and attempted and failed prior noninvasive treatment (behavior modification, bladder training exercises, pelvic muscle rehabilitation, biofeedback, electrical or drug therapy) while incontinent? 4. Is the patient available for the minimum study duration of 12 months with a maximum duration of 3 years? 5. Is the patient willing to undergo cystoscopic and urodynamic procedures required during the study period? 6. Has the patient been on stable medication for a minimum of 3 months? 7. Is the patient free of uncontrolled psychiatric illness? 8. Is the patient alert, oriented, mentally competent, and capable of determining their need to void by sensing and responding to an urge to void? 9. Is the patient free of local genital skin infection? 10. Did the patient have a Positive 1-hour Pad Weight (in-office provocative) Test of * 5 g? 11. Is the patient free of impassable urethral strictures, trauma or necrosis? 12. Does the patient have a baseline I-QOL score of *80?
Exclusion criteria
Exclusion criteria: 1. Is the patient pregnant or planning to become pregnant during the study period? 2. Does the patient have a life expectancy of 100 cc consistently? 32. Does the patient have a urinary flow rate of 400 cc? 34. Does the p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Endpoints: The following endpoints will be assessed by assigned treatment and comparison to control at 3 months, and all patients as a single group at 12 months after enrollment: 1. Percent of patients with improvement in Patient Global Impression of Improvement of Incontinence (PGI-I) 2. Percent of patients with improvement in Incontinence Quality of Life (I QOL) 3. Percent of patients with 10 pt. improvement in I-QOL 4. Percent of patients with a reduction in Incontinence Episode Frequency 5. Percent of patients with 50% reduction in Incontinence Episode Frequency 6. Percent of patients with a reduction in provocative pad weight 7. Percent of patients with 50% reduction in provocative pad weight The above endpoints will also be combined in the form of composite endpoints to reduce the impact of the placebo effect and increase the power of the statistical analysis. These composite endpoints will be assessed by assigned treatment and comparison to control at 3 months and include: 1. Percent of patients with at least a 50% reduction in provocative pad weight AND Percent of patients with improvement in PGI-I score 2. Percent of patients with at least a 50% reduction in provocative pad weight AND Percent of patients with 10 pt. or greater improvement in I-QOL 3. Percent of patients with at least a 50% reduction in provocative pad weight AND Percent of patients with 50% or greater reduction in Incontinence Episode Frequency In addition, for all subjects in the Control Group, the study endpoints will be evaluated by comparing the second 3 month period with the Solace Balloon to the first 3 month period without the Solace Balloon. Safety Endpoints: The study safety endpoints will include incidence of treatment related mild, moderate or severe adverse events observed over the study assessment period, compared between the Treatment and Control Groups. In addition, incidence and severity of all adverse events experienced over the entir | — |
Secondary
| Measure | Time frame |
|---|---|
| N.A. | — |
Countries
Netherlands
Outcome results
None listed