NCT04772131

Desara ® One Single Incision Sling 522 Study

Prospective, Post-market Study of the Desara® One Single Incision Sling vs. Desara® Blue Sling Implanted Via the Transobturator Route for the Treatment of Women With Stress Urinary Incontinence

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Caldera Medical, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A post-market study to compare the safety and effectiveness of the Desara® One Single Incision Sling (SIS), when compared to that of an FDA cleared transobturator sling over a period of 36 months.

Detailed 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 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 2 and 6 weeks, 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).

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Desara® One Single Incision Sling	Single incision sling
DEVICE	Desara® Blue Transobturator Sling	Standard mid-urethral sling

Timeline

• Start date: 2021-11-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2021-02-26
• Last updated: 2025-09-19

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated device study