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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04793126

Enrollment

Registered

2021-03-11

Start date

2014-12-01

Completion date

2018-12-01

Last updated

2021-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

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.

Interventions

DIAGNOSTIC_TESTUrodynamic study

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention 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.

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026