Study Comparing Desara4 Single Incision Sling to Desara4 Blue Transobturator Sling for Treating Female Stress Urinary Incontinence

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Desara4 One Single Incision Sling SIS compared to the Desara4 Blue sling system implanted through the transobturator-route TOR to treat women with stress urinary incontinence SUI. This study involves adult females experiencing SUI due to urethral hypermobility andor intrinsic sphincter deficiency ISD. The study is prospective, non-randomized, and conducted at multiple centers over 36 months. The study compares two devices the Desara4 One Single Incision Sling and the Desara4 Blue Transobturator Sling. Each device will be implanted in separate groups of 150 participants. Follow-up visits are scheduled at 2 and 6 weeks, then at 6, 12, 18, 24, and 36 months after implantation. Participants may also undergo concomitant laparoscopic, robotic, or vaginal prolapse repair surgeries if needed. Participants will attend regular visits for evaluations including cough stress tests, sexual function assessments, pain assessments, and urinary symptom improvements. Researchers will monitor serious adverse events related to the devices and procedures, as well as measure success rates of negative cough stress tests at 36 months. The total study participation spans three years with multiple assessments to track outcomes and safety.

Desara ® One Single Incision Sling 522 Study