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Clinical Trials/NCT04793126
NCT04793126CompletedPhase 2

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

Ain Shams University0 sites83 target enrollmentStarted: December 1, 2014Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
83
Primary Endpoint
Urodynamic study evaluation for the participants
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Urodynamic study evaluation for the participants

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Maher Gamil Ahmed Higazy

Assistant lecturer

Ain Shams University

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Clinical and Urodynamic Evaluation of... | Clinical Trial