Comparing outcomes between the use of autologous fascia lata graft versus synthetic polypropylene mesh for sacrocolpopexy in the treatment of apical vaginal prolapse

Not Applicable

Recruiting

• Conditions: Pelvic organ prolapse; Recurrent pelvic organ prolapse; Renal and Urogenital - Other renal and urogenital disorders; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders; Surgery - Other surgery

• Registration Number: ACTRN12624000651583
• Lead Sponsor: Gold Coast Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-21
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Patients assessed by subspecialist Urogynaecologist (Certificate of Urogynaecology - RANZCOG) who are candidates for sacrocolpopexy treatment for apical vaginal prolapse
- Care at one of the three sites: Varsity Lakes/Robina Hospital, Pindara Private Hospital or Greenslopes Private Hospital
- Who have their care between 1st April 2023 – 1st April 2028

Exclusion Criteria

Those not appropriate for sacrocolpopexy surgery
Those unable to understand the study and/or provide informed consent
Those having care at sites not listed for the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite outcome of success” defined as the absence of:<br>1.Descent of apex more than 1/3 of vaginal canal<br>2.Anterior or posterior descent beyond hymen<br>3.bothersome vaginal bulge symptoms<br>4.retreatment for Pelvic organ prolapse (POP) with pessary and/or surgery<br>[Clinical - patient history and examination. Information will be collected by medical practitioners at scheduled patient visits. Examination will be completed by a Urogynaecologist or Urogynaecology Accredited Trainee. The information will be recorded in the patient's electronic record and then data will be collated by the research fellow and team. Assessed at 6 weeks, 6 months, then yearly for 5 years (post-surgery - primary timepoint) ]