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

NCT06429228 | Completed

• 1 other identifier: CAT_273219
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Catheter Related Complication; Anterior Vaginal Wall Prolapse

Outcome Measures

Primary Outcomes (1)

• differences in bladder catheter repositioning within 12 hours after bladder catheter removal

  After removal of the bladder catheter, on postoperative day I or II, the appearance of urinary urge will be assessed and, in case of spontaneous urination, the quantity of urine will be measured. In the event that after the waiting time of 6 hours an adequate urination stimulus does not arise, we will proceed with an ultrasound evaluation of bladder stagnation (RV) and the application of the department protocol, as follows: * if the sum of diuresis and RV is between 500 and 1000 cc, extemporaneous catheterization and re-evaluation after 4 hours are indicated * if the sum of diuresis and RV is \> 1000cc, positioning of a bladder catheter and maintenance of the same for 5-7 days with subsequent evaluation is indicated.

  12 hours

Secondary Outcomes (1)

• incidence of urinary tract infections for patients undergoing cystopexy surgery in patients in whom the bladder catheter is removed on postoperative day I or II.

  During hospital stay

Study Arms (2)

Catheter removal in postoperative day I

EXPERIMENTAL

Procedure: Catheter removal after surgery

Catheter removal in postoperative day II

EXPERIMENTAL

Procedure: Catheter removal after surgery

Interventions

Catheter removal after surgery PROCEDURE

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

Catheter removal in postoperative day I; Catheter removal in postoperative day II

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele Hospital

Milan, 20132, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: May 24, 2024
• Study Start: April 20, 2020
• Primary Completion: April 18, 2024
• Study Completion: January 1, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)