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

NCT04793126 | Completed Phase 2 DMC

• 1 other identifier: FAMSU 1743/2013
• Study Type: interventional
• Target: 83
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Urodynamic study DIAGNOSTIC_TEST

comparison between the urodynamic study of the patients before pelvic prolapse surgical repair and 6 months later.

Eligibility Criteria

• Gender Eligibility Details: Pelvic organ prolapse surgeries
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: All patients were subjected to clinical evaluation and urodynamic testing before surgery. All cases underwent surgical repair of pelvic organ prolapse. Follow-up clinical examination was performed at 1, 3, and 6 months postoperatively, and urodynamic examination was repeated 6 months after repair.

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 11, 2021
• Study Start: December 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2018
• Last Updated: March 11, 2021

Record last verified: 2021-03