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

Primary Purpose

Urinary Retention, Pelvic Organ Prolapse

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Removing urinary catheter

About this trial

This is an interventional prevention trial for Urinary Retention focused on measuring Urinary Retention, Pelvic Organ Prolapse, Vaginal surgery, Urinary catheter

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Rajavithi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Removing urinary catheter at 24 hours after surgery

Removing urinary catheter at 48 hours after surgery

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT04954443

First Posted

May 12, 2021

Last Updated

October 27, 2022

Sponsor

Rajavithi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04954443

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

July 1, 2021 (Actual)

Primary Completion Date

September 30, 2022 (Actual)

Study Completion Date

September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rajavithi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Retention, Pelvic Organ Prolapse

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigator

Masking Description

Single blind (Care provider, investigator)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Removing urinary catheter at 24 hours after surgery

Arm Type

Experimental

Arm Description

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

Arm Title

Removing urinary catheter at 48 hours after surgery

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Removing urinary catheter

Intervention Description

Removing urinary catheter after vaginal surgery of pelvic organ prolapse

Primary Outcome Measure Information:

Title

Urinary retention

Description

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

Time Frame

Through study completion, an average of 1 year

Secondary Outcome Measure Information:

Title

Re-catheterization after removing urinary catheter

Description

Incident of re-catheterization after removing urinary catheter at 24 hour comparison with 48 hour after vaginal surgery of pelvic organ prolapse

Time Frame

Through study completion, an average of 1 year

Title

Urinary tract infection

Description

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

Time Frame

Through study completion, an average of 1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Rajavithi Hospital

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

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

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