Single Incision Pelvic Floor Mesh Implants

Phase 2

Completed

• Conditions: Intra-operative Complications; Post Operative Complications
• Interventions: Device: Single Incision Mesh

• Registration Number: NCT01909700
• Lead Sponsor: Western Galilee Hospital-Nahariya

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 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 Timeline

• Study Start: 2011-07
• Primary Completion: 2011-11
• Study Completion: 2012-02
• Status Verified: 2013-07
• Study First Submitted: 2013-07-24
• Study First Submitted QC: 2013-07-24
• Study First Posted: 2013-07-26
• Last Update Submitted: 2016-05-04
• Last Update Posted: 2016-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 157

Inclusion Criteria

* Patients with Gr 2-3 Pelvic Organ Prolapse

Exclusion Criteria

*Previous Pelvic irradiation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Incision Mesh	Single Incision Mesh	intervention: single incision mesh implantation

Primary Outcome Measures

Name	Time	Method
Operative mesh related complications	12 Months

Trial Locations

Locations (1)

Assuta MC; 🇮🇱 Tel Aviv, Israel