Stress Urinary Incontinence
Conditions
Interventions
TephaFlex resorbable sling
Sponsors
Pelvic Floor Foundation of South Africa
University of Cape Town
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: To be eligible for enrollment, the subject must: 1. Be female, = 18 years of age 2. Female symptomatic (moderate or severe) SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). 3. Patients who have planned to undergo surgical correction of symptomatic SUI after consultation with their physician about the risks and benefits of such a procedure, and a determination by the physician that surgical treatment is the most appropriate treatment option for the patient. 4. Understand and be willing to follow all aspects of the study protocol and have signed and dated the EC-approved Informed Consent prior to any study-related procedures being performed
Exclusion criteria
Exclusion criteria: 1. Subjects who have mixed or urge incontinence 2. Subjects who have stage 2 or more genital prolapse, according to the ICS classification 3. Subjects with previous surgery for SUI 4. Subjects who undergo concomitant surgical procedures 5. Subjects who are pregnant or want to become pregnant in the next 24 months 6. Subjects who are not capable of giving informed consent 7. Subjects with a BMI = 35 kg/m2 8. Subjects diagnosed with a current urinary tract infection or chronic urinary tract infections (defined as 4 or more UTI in the last year) 9. Subjects with known sensitivity to tetracycline or kanamycin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The retropubic mid-urethral sling procedure using UroFLEX sling is considered to be safe at 6 months after implantation if the number of serious adverse events comply with safety standards as defined by the safety criteria outlined below and analyzed using sequential analysis. All pelvic floor related adverse events will be collected and assessed for seriousness, severity, and relationship to device/procedure. Events will be classified as adverse events, serious adverse events, and major and minor complications. Major complications are classified as device and/or procedure related adverse events, and must be Dindo Grade III or higher. The use of UroFLEX sling implanted via a retropubic mid-urethral sling procedure is considered to be safe when in the first six months following implantation: A) a maximum of 3 of the first 5 patients experience a device or procedure-related SAE (60%); B) a maximum of 5 of the first 10 patients experience a device or procedure-related SAE (50%); C) a maximum of 7 of the first 20 patients experience a device or procedure-related SAE (35%); D) a maximum of 8 of the first 25 patients experience a device or procedure-related SAE (32%). The type and nature of the SAE(s) will be examined by a Data Monitoring Committee prior to the determination of safety of the device | — |
Secondary
| Measure | Time frame |
|---|---|
| Preliminary effectiveness will be assessed by examining: • # of patients that exhibit subjective cure based on PGI-I questionnaire at 4-6 weeks, 3, 6, 12 and 24 months; • # of patients that exhibit objective cure based on Cough Stress Test at 4-6 weeks, 3, 6, 12 and 24 months; • Sandvik scores at 4-6 weeks, 3, 6, 12 and 24 months • Collecting quality of life scores using IIQ-7 and UDI-6 questionnaires at 4-6 weeks, 3, 6, 12 and 24 months • Collecting quality of life scores using PISQ-IR questionnaire at 3, 6, 12 and 24 months Safety assessments will include: • Number of device- or procedure-related adverse events will be collected on a continual basis and summarized at each of the following timepoints: 4-6 weeks, 3, 6, 12, and 24 months after the procedure. Additional measures: • Collection of operation characteristics (i.e. duration, anesthesia); • Collection of rate and time of duration of catheter use after the operation | — |
Countries
South Africa
Contacts
Public ContactLeigh Anne Davids
Manager
Outcome results
None listed