Desara ® One Single Incision Sling 522 Study
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Stress Urinary Incontinence
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Adult female subjects, who in the opinion of their physician require surgical treatment or who have already been diagnosed with stress urinary incontinence, will be eligible for study participation. Subjects who provide informed consent will undergo screening and baseline assessments. Subjects who successfully meet the study's inclusion and exclusion criteria will be eligible to undergo a Desara SIS or Desara Blue implant procedure, with subsequent follow-up assessments. The choice of implant, Desara One or Desara Blue, will be determined by the investigator based upon patient pathology and surgical preference.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
This study is a prospective, non-randomized, parallel cohort, multi-center study of Desara® One single incision sling (SIS) compared to Desara® Blue sling systems implanted via the transobturator-route (TOR) for the treatment of women with stress urinary incontinence (SUI). The study will compare re...
This study is a prospective, non-randomized, parallel cohort, multi-center study of Desara® One single incision sling (SIS) compared to Desara® Blue sling systems implanted via the transobturator-route (TOR) for the treatment of women with stress urinary incontinence (SUI). The study will compare results from SIS patients (N=150) and TOR patients (N=150) at up to 40 sites for a total period of 36 months, with follow-up visits at 6, 12, 18, 24 and 36 months. This study will enroll adult females who are clinically indicated for a mid-urethral implant for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
Tracking Information
- NCT #
- NCT04772131
- Collaborators
- Not Provided
- Investigators
- Not Provided
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