Single Incision Pelvic Floor Mesh Implants

Post Operative Complications Clinical Trial

Official title:

Single Incision Pelvic Floor Mesh Implants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01909700
• Other study ID #: 2011041
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 24, 2013
• Last updated: May 4, 2016
• Start date: July 2011
• Est. completion date: February 2012

Study information

• Verified date: July 2013
• Source: Western Galilee Hospital-Nahariya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: February 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients with Gr 2-3 Pelvic Organ Prolapse

Exclusion Criteria:

*Previous Pelvic irradiation

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

Intervention

Device:
• Single Incision Mesh
Single Incision Mesh is implanted for pelvic floor reconstruction

Locations

Country	Name	City	State
Israel	Assuta MC	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative mesh related complications		12 Months	Yes