Comparing Vaginal And Laparoscopic Uterosacral Suspension For Pelvic Organ Prolapse

Not Applicable

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

• Registration Number: ACTRN12621001246875
• Lead Sponsor: Anna Rosamilia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-15
• Last Update Posted: 20 September 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 170

Inclusion Criteria

All participants between the ages of 18-80 with symptomatic stage II-III POP requesting surgery including hysterectomy
Capable of providing informed consent and able to return for follow up.

Exclusion Criteria

Any previous prolapse surgery
Previous surgery in the treatment area in the last year.
Systemic steroids use within the last 3 months
Pelvic organ prolapse (POP) > stage 3 according to pelvic organ prolapse quantification system
Transvaginal mesh
Serious systemic disease or any chronic condition that could interfere with study compliance
Co-morbidities that would make a laparoscopic approach inappropriate
A surgical history that would make a vaginal or laparoscopic approach innapropriate
Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>To assess the success of L-USLS and V-USLS defined as combined:<br>•No symptomatic recurrence, No anatomical recurrence beyond the hymen for anterior and posterior repair and -1 for the vault andNo pelvic organ prolapse (POP) retreatment (multiple components assessed as one primary outcome)<br>[6 months, 2 years (primary endpoint) and 5 years post procdure]