Back to resultsClinical and Urodynamic Evaluation of Surgical Repair of Pelvic Organ Prolapse Associated With Lower Urinary Tract Symptoms
Primary Purpose
Pelvic Organ Prolapse
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Urodynamic study
Sponsored by
About this trial
This is an interventional diagnostic trial for Pelvic Organ Prolapse
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04793126
Brief Title
Clinical and Urodynamic Evaluation of Surgical Repair of Pelvic Organ Prolapse Associated With Lower Urinary Tract Symptoms
Official Title
Clinical and Urodynamic Evaluation of Surgical Repair of Pelvic Organ Prolapse Associated With Lower Urinary Tract Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2014 (Actual)
Primary Completion Date
July 1, 2016 (Actual)
Study Completion Date
December 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
Urodynamic study
Intervention Description
comparison between the urodynamic study of the patients before pelvic prolapse surgical repair and 6 months later.
Primary Outcome Measure Information:
Title
Urodynamic study evaluation for the participants
Description
evaluation of the urodynamic study after the surgical repair of the pelvic organ prolapse and comparison to the preoperative results.
Time Frame
6 month after the procedure
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pelvic organ prolapse surgeries
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Clinical and Urodynamic Evaluation of Surgical Repair of Pelvic Organ Prolapse Associated With Lower Urinary Tract Symptoms
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