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

NCT04954443 | Completed

• 1 other identifier: 084/2564
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Urinary Retention; Pelvic Organ Prolapse

Keywords

Urinary Retention; Pelvic Organ Prolapse; Vaginal surgery; Urinary catheter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Re-catheterization after removing urinary catheter

  Through study completion, an average of 1 year

• Urinary tract infection

  Through study completion, an average of 1 year

Study Arms (2)

Removing urinary catheter at 24 hours after surgery

EXPERIMENTAL

The participants will removing urinary catheters at 24 hour after vaginal surgery of pelvic organ prolapse.

Procedure: Removing urinary catheter

Removing urinary catheter at 48 hours after surgery

PLACEBO COMPARATOR

The participants will removing urinary catheters at 48 hour after vaginal surgery of pelvic organ prolapse.

Procedure: Removing urinary catheter

Interventions

Removing urinary catheter PROCEDURE

Removing urinary catheter after vaginal surgery of pelvic organ prolapse

Removing urinary catheter at 24 hours after surgery; Removing urinary catheter at 48 hours after surgery

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Urinary Retention; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Single blind (Care provider, investigator)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: July 8, 2021
• Study Start: July 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: October 31, 2022

Record last verified: 2022-10

Locations

TH (1)