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

Urinary Retention After Removing Urinary Catheter at 24 Hour Comparison With 48 Hour in Patients With Vaginal Surgery of Pelvic Organ Prolapse, Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse; Urinary Retention
• Intervention / Treatment: Procedure: Removing urinary catheter

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Rajavithi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Removing urinary catheter at 24 hours after surgery; The participants will removing urinary catheters at 24 hour after vaginal surgery of pelvic organ prolapse.	Procedure: Removing urinary catheter; Removing urinary catheter after vaginal surgery of pelvic organ prolapse
Placebo Comparator: Removing urinary catheter at 48 hours after surgery; The participants will removing urinary catheters at 48 hour after vaginal surgery of pelvic organ prolapse.	Procedure: Removing urinary catheter; Removing urinary catheter after vaginal surgery of pelvic organ prolapse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary retention	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	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-catheterization after removing urinary catheter	Incident of re-catheterization after removing urinary catheter at 24 hour comparison with 48 hour after vaginal surgery of pelvic organ prolapse	Through study completion, an average of 1 year
Urinary tract infection	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	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Rajavithi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Pelvic Organ Prolapse; Urinary Retention; Urinary catheter; Vaginal surgery
• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse; Urinary Retention
• Other Study ID Numbers: 084/2564

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No