The Gynecel Trial for Pelvic Floor Reconstruction using a Biomaterial Mesh in women with symptomatic anterior vaginal wall prolapse

Not Applicable

Recruiting

• Conditions: Surgery - Other surgery; Renal and Urogenital - Other renal and urogenital disorders; Anterior vaginal wall prolapse

• Registration Number: ACTRN12610000002088
• Lead Sponsor: Dr Gregory M Cario

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

Women with symptomatic pelvic organ prolapse of POP-Q Stage II - IV, suitable for surgery
Post-menopausal state

Exclusion Criteria

Previous repair of pelvic organ prolapse involving insertion of mesh
Pregnant or intending future pregnancy
Morbid obesity > 110kg
Body Mass Index >30
Active genital/urinary/systemic infection at the time of surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified