Clinical and Urodynamic Evaluation of Surgical Repair of Pelvic Organ Prolapse Associated With Lower Urinary Tract Symptoms

Phase 2

Completed

• Conditions: Pelvic Organ Prolapse

• Registration Number: NCT04793126
• Lead Sponsor: Ain Shams University

Brief Summary

To assess the urinary symptoms and urodynamic findings concomitant with Pelvic organ prolapse before and after surgical treatment and to define the role of urodynamic study in treatment decision making.

Detailed Description

Pelvic organ prolapse (POP) is a prevalent problem that affects women's quality of life women with POP may present with a variety of lower urinary tract symptoms (LUTS).

For POP patients with concomitant urinary symptoms, urodynamic (UDN) testing is proposed for proper evaluation of cases and identification of the pathophysiologic events in each case individually.

In this prospective study, the investigators aim to describe the urinary symptoms and urodynamic findings concomitant with POP before and after surgical treatment of POP. We also aimed at defining the role of UDN in decision-making regarding the treatment of POP when associated with LUTS.

Study Timeline

• Study Start: 2014-12-01
• Primary Completion: 2016-07-01
• Study Completion: 2018-12-01
• Status Verified: 2021-03
• Study First Submitted: 2021-03-09
• Study First Submitted QC: 2021-03-09
• Last Update Submitted: 2021-03-09
• Study First Posted: 2021-03-11
• Last Update Posted: 2021-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 83

Inclusion Criteria

• women with anterior pelvic organ prolapse (POP) associated with Lower urinary tract symptoms

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Exclusion Criteria

• Patients with POP less than POP-Q grade II, POP not in need for surgical repair, neurological diseases that could possibly affect voiding functions, pelvic infections, congenital bladder disorders, history of urinary fistula, history of malignancy, and patients on current medical treatment for voiding dysfunction.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Urodynamic study evaluation for the participants	6 month after the procedure	evaluation of the urodynamic study after the surgical repair of the pelvic organ prolapse and comparison to the preoperative results.