Clinical Trial: Single Incision Pelvic Floor Mesh Implants

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Single Incision Pelvic Floor Mesh Implants

Brief 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 Summary: 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
Sponsor: Western Galilee Hospital-Nahariya

Current Primary Outcome: Operative mesh related complications [ Time Frame: 12 Months ]

Original Primary Outcome: Operative mesh related complications [ Time Frame: 12 Monthes ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Western Galilee Hospital-Nahariya

Dates:
Date Received: July 24, 2013
Date Started: July 2011
Date Completion:
Last Updated: May 4, 2016
Last Verified: July 2013