Prospective study to evaluate use of TephaFLEX sling implanted via aretropubic mid-urethral sling procedure for treatment of women withstress urinary incontinence
- Conditions
- Stress Urinary Incontinence
- Registration Number
- PACTR201808641266843
- Lead Sponsor
- Pelvic Floor Foundation of South Africa
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 25
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method