NCT05170074

Post-market Clinical Follow-up of the SRS Implant

National, Multicentre Observational Study on Surgical Reconstruction of the Anterior and Apical Compartment of the Pelvic Floor With a Single-incision, Fixation-free Self-Retaining Support Implant (SRS Implant)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 175 (estimated)
• Sponsor: pfm medical gmbh · Industry
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

National, multicentre observational study on surgical reconstruction of the anterior and apical compartment of the pelvic floor with an SRS implant

Detailed description

National, multicentre, prospective observational study on surgical reconstruction of the anterior and apical compartment in seven clinical centres in Germany to obtain post-market information on the SRS implant with a follow-up of 24 months. Patient reported satisfaction (measured by P QoL, Prolapse Quality of Life Questionnaire), anatomic outcome (measured by the POP-Q, Pelvic Organ Prolapse Quantification system) and the rate of complications (measured by adverse events during the study period) are focused.

Conditions

• Pelvic Organ Prolapse

Timeline

• Start date: 2022-04-07
• Primary completion: 2025-09-01
• Completion: 2026-09-01
• First posted: 2021-12-27
• Last updated: 2025-04-02

Locations

7 sites across 1 country: Germany