Comparison of 1 Versus 2 Days Post-Operative Catheterization After Anterior Colporrhaphy

NCT ID: NCT06429228

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-20

Study Completion Date

2025-01-01

Brief Summary

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Patients who undergo anterior vaginal wall plastic surgery and place the bladder catheter during surgery are selected. The purpose of the study is to evaluate the presence of statistically significant differences in bladder catheter repositioning within 12 hours after bladder catheter removal in the group of patients in whom the bladder catheter is removed on postoperative day I or II.

Secondary outcomes include evaluation of the incidence of urinary tract infections, number of hospitalization days and total hospitalization costs for patients undergoing anterior vaginal wall surgery in patients in whom the bladder catheter is removed on postoperative day I or II.

Detailed Description

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Conditions

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Catheter Related Complication Anterior Vaginal Wall Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Catheter removal in postoperative day I

Group Type EXPERIMENTAL

Catheter removal after surgery

Intervention Type PROCEDURE

Removal of catheter placed during the procedure in first or second post-surgical days.

Catheter removal in postoperative day II

Group Type EXPERIMENTAL

Catheter removal after surgery

Intervention Type PROCEDURE

Removal of catheter placed during the procedure in first or second post-surgical days.

Interventions

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Catheter removal after surgery

Removal of catheter placed during the procedure in first or second post-surgical days.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women 18 years of age or older
* Patients who are candidates for cystopexy surgery
* Patients who have consented to the signing of the Informed Consent

Exclusion Criteria

* Micturition dysfunction with preoperative bladder stagnation \> 200 cc at pessary evaluation
* History of recurrent cystitis
* Positive preoperative urine culture
* Azotemia \> 40 mg/dL or creatininemia \> 1 mg/dL
* Not collected signed consent endorsed
* Diabetes mellitus
* Contraindications to transurethral bladder catheterization
* Major protocol violations due to unforeseen intraoperative complications (bladder and/or rectal damage, severe bleeding with need for urinary monitoring)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Stefano Salvatore

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS San Raffaele Hospital

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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CAT_273219

Identifier Type: -

Identifier Source: org_study_id

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