Desara ® One Single Incision Sling 522 Study

Status Recruiting

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04772131
Study type	Interventional
Source	Caldera Medical, Inc.
Contact	Vicki Gail
Phone	818-483-7602
Email	vgail@calderamedical.com
Status	Recruiting
Phase	N/A
Start date	November 1, 2021
Completion date	November 2026

View Details

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