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

NCT ID: NCT04954443

Last Updated: 2022-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-09-30

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.

Conditions

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Urinary Retention Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Investigators
Single blind (Care provider, investigator)

Study Groups

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Removing urinary catheter at 24 hours after surgery

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

Group Type EXPERIMENTAL

Removing urinary catheter

Intervention Type PROCEDURE

Removing urinary catheter after vaginal surgery of pelvic organ prolapse

Removing urinary catheter at 48 hours after surgery

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

Group Type PLACEBO_COMPARATOR

Removing urinary catheter

Intervention Type PROCEDURE

Removing urinary catheter after vaginal surgery of pelvic organ prolapse

Interventions

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Removing urinary catheter

Removing urinary catheter after vaginal surgery of pelvic organ prolapse

Intervention Type PROCEDURE

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Department of Medical Services Ministry of Public Health of Thailand

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rajavithi Hospital

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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084/2564

Identifier Type: -

Identifier Source: org_study_id

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