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NCT04793126 Clinical Trial

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

Pelvic Organ Prolapse Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04793126
Other study ID # FAMSU 1743/2013
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date December 1, 2014
Est. completion date December 1, 2018

Study information
Verified date March 2021
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 83
Est. completion date December 1, 2018
Est. primary completion date July 1, 2016
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - women with anterior pelvic organ prolapse (POP) associated with Lower urinary tract symptoms 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Urodynamic study
comparison between the urodynamic study of the patients before pelvic prolapse surgical repair and 6 months later.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Outcome
Type Measure Description Time frame Safety issue
Primary Urodynamic study evaluation for the participants evaluation of the urodynamic study after the surgical repair of the pelvic organ prolapse and comparison to the preoperative results. 6 month after the procedure
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