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

Sponsor

Rajavithi Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04954443

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Urinary Retention Pelvic Organ Prolapse	Procedure: Removing urinary catheter	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Investigator)

Masking Description:

Single blind (Care provider, investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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