Urinary Retention After Removing Urinary Catheter at 24 Hour Versus 48 Hour in Patients With Vaginal Surgery

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse; Urinary Retention
• Interventions: Procedure: Removing urinary catheter

• Registration Number: NCT04954443
• Lead Sponsor: Rajavithi Hospital

Brief Summary

Comparison incident of urinary retention in patients with vaginal surgery of pelvic organ prolapse, who removed urinary catheter at 24 hours versus 48 hours after surgery

Detailed Description

Vaginal surgery of pelvic organ prolapse needs to insert urinary catheter for monitoring post-operative complication, hemodynamic status, and prevention post-operative urinary retention. Urinary retention occur 2.4 - 43% after pelvic organ prolapse surgery, whereas retaining urinary catheter is common cause of urinary tract infection, often hospital-acquired infection. At Rajavithi hospital always remove urinary catheter at 48 hour after surgery. Accordingly, appropriated time for removing urinary catheter in patients with vaginal surgery of pelvic organ prolapse is unclear. This study aims to reduce timing for removing urinary catheter after vaginal surgery, not increase urinary retention and re-catheterization and reduce urinary tract infection and day of hospital stay.

Study Timeline

• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-06-29
• Study Start: 2021-07-01
• Study First Posted: 2021-07-08
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-27
• Last Update Posted: 2022-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Woman with pelvic organ prolapse, who undergoing vaginal surgery and agrees to participate in this study
• Able to understand and communicate Thai language

Exclusion Criteria

• Woman with diabetes mellitus with HbA1C > 10.9%
• Woman with stroke
• Woman with urinary tract infection before surgery
• Woman with urinary retention before surgery
• Woman, who experienced surgery for urinary incontinence
• Woman, with operative complication including of hemorrhagic shock (Blood pressure < 90/60 mmHg, Heart rate > 120 beats per minute, Intra-operative blood loss > or = 750 ml), urinary tract injury, bowel injury

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Removing urinary catheter at 24 hours after surgery	Removing urinary catheter	The participants will removing urinary catheters at 24 hour after vaginal surgery of pelvic organ prolapse.
Removing urinary catheter at 48 hours after surgery	Removing urinary catheter	The participants will removing urinary catheters at 48 hour after vaginal surgery of pelvic organ prolapse.

Primary Outcome Measures

Name	Time	Method
Urinary retention	Through study completion, an average of 1 year	Incident of urinary retention (Post-void residual urine at least 150 ml) after removing urinary catheter at 24 hour comparison with 48 hour after vaginal surgery of pelvic organ prolapse

Secondary Outcome Measures

Name	Time	Method
Urinary tract infection	Through study completion, an average of 1 year	Incident of urinary tract infection (positive urine culture) after removing urinary catheter at 24 hour comparison with 48 hour after vaginal surgery of pelvic organ prolapse
Re-catheterization after removing urinary catheter	Through study completion, an average of 1 year	Incident of re-catheterization after removing urinary catheter at 24 hour comparison with 48 hour after vaginal surgery of pelvic organ prolapse

Trial Locations

Locations (1)

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand