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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Urinary Retention, Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: Removing urinary catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Retention, Pelvic Organ Prolapse, Vaginal surgery, Urinary catheter