NCT01909700

Single Incision Pelvic Floor Mesh Implants

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Western Galilee Hospital-Nahariya · Other Government
• Sex: Female
• Age: 30 Years – 90 Years
• Healthy volunteers: Accepted

Summary

Objectives: To evaluate whether the use of single incision un-anchored small mesh implants is feasible, safe and effective for women with moderate pelvic organ prolapse. Design: Patients diagnosed with moderate pelvic organ prolapse were enrolled to undergo a single incision un-anchored mesh operation. Follow-up was 4 to 23 months. The outcome measures for this study were the operative safety and post-operative pain, adverse effects and anatomical as well as functional cure. Setting: The operations were performed under general anesthesia according with the reported surgical techniques at university and private hospitals.

Detailed description

Eligibility criteria: female patients with moderate pelvic organ prolapse Outcome measures: intra operative safety and surgical complications, post operative complications and objective as well as subjective cure rates

Conditions

• Intra-operative Complications
• Post Operative Complications

Interventions

Type	Name	Description
DEVICE	Single Incision Mesh	Single Incision Mesh is implanted for pelvic floor reconstruction

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-11-01
• Completion: 2012-02-01
• First posted: 2013-07-26
• Last updated: 2016-05-05

Locations

1 site across 1 country: Israel