NCT01378065

Restorelle Direct Fix Anterior and Posterior (A&P) for Female Pelvic Organ Prolapse: A Prospective Post Market Study

Restorelle Direct Fix A&P for Female Pelvic Organ Prolapse: A Prospective Post Market Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 31 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center study designed to assess the palpability of the Restorelle Direct Fix A\&P mesh after vaginal reconstruction surgery.

Conditions

• Pelvic Organ Prolapse (POP)

Interventions

Type	Name	Description
DEVICE	Restorelle Direct Fix A&P	Restorelle Direct Fix A\&P is a permanently implantable synthetic mesh for reconstruction of the pelvic floor secondary to the prolapse or protrusion of the pelvic organs into or out of the vaginal canal.

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2011-06-22
• Last updated: 2020-05-12
• Results posted: 2015-10-28

Locations

6 sites across 1 country: United States