Post-operative pessary in prolapse surgery and its impact on recurrent prolapse

Not Applicable

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

• Registration Number: ACTRN12622001018707
• Lead Sponsor: Mater Hospital - Pimlico

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-20
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Women (18 years and over) with symptomatic pelvic organ prolapse requiring an anterior vaginal repair (level 1 or level 2) at our facility
-Medically fit for surgery
-Able to complete the questionnaire independently with reasonable level of English and English is their first language
-Patients that have not been recommended surgery that involves colpocleisis, mesh or other surgical approach (such as laparoscopy or laparotomy)

Exclusion Criteria

-Asymptomatic pelvic organ prolapse
-Refusal to participate
-Women of non-English speaking background

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success in anterior compartment at 6 months post operation<br><br>Success is defined as a composite of objective findings and subjective patient report. <br><br>Objective anatomic success is defined as anterior prolapse no greater than Stage 1 (reference point Ba < -1cm on Pelvic Organ Prolapse Quantifications System (POP Q) examination. <br><br>Subjective success as defined as absence of bulge” symptom based on the PDFI-20 validated questionnaire. <br><br>Failure will be defined as leading edge of anterior vaginal wall a Stage 2 or more (reference point Ba >= -1cm) or presence of vaginal bulge” symptom on validated questionnaire.<br>[6 months post operative]