Single Incision Pelvic Floor Mesh Implants

Post Operative Complications Clinical Trial

Official title: Single Incision Pelvic Floor Mesh Implants

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intra-operative Complications
• Intraoperative Complications
• Post Operative Complications
• Postoperative Complications

• NCT number: NCT01909700
• Study type: Interventional
• Source: Western Galilee Hospital-Nahariya
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 2011
• Completion date: February 2012