When is the Best Moment to Remove the Urinary Catheter After Laparoscopic Hysterectomy?

Study Overview
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Brief Summary
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Objective: The aim of this study is to evaluate if direct removal of the urine catheter after an laparoscopic hysterectomy (total laparoscopic hysterectomy and laparoscopic supracervical hysterectomy) is associated with similar (or better) outcomes compared to delayed catheter removal after surgery, which is the current treatment. In addition, we want to investigate patient's experience on this subject. Study design: Randomized Controlled trial, non-inferiority study. Study population: Women older than 18 years old, who are a laparoscopic hysterectomy for benign indication or low-grade malignancy. Intervention: Group A (treatment group): the patients in this group will have their catheter directly removed in the OR after LH. Group B (control group): the patients in the control group will have their catheter removed according to the regular protocol of the hospital (at least 6 hours in place).

Official Title
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When is the Best Moment to Remove the Urinary Catheter After Laparoscopic Hysterectomy: MUCH Study.

Conditions
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Urinary Tract Infection, Bladder Retention

Intervention / Treatment
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* Device: Foley catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 18 years Scheduled for LH for benign indication or low-grade malignancy (with or without salpingo-oophorectomy) Exclusion Criteria: Concomitant procedures such as prolapse surgery, severe endometrioses and/or bowel resection Preoperative known urinary voiding problems (incontinence) Preoperative known urinary tract infection Patients suffering from diseases potentially associated with inability to void (e.g. MS) A Gravid or postpartum hysterectomy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (treatment group)<br>The patients in this group will have their catheter directly removed in the OR after LH. | Device: Foley catheter<br>* The aim of this study is to evaluate if direct removal of the urine catheter after an LH (total laparoscopic hysterectomy and laparoscopic supracervical hysterectomy) is associated with similar (or better) outcomes compared to delayed catheter removal after surgery.<br>|
| Active Comparator: Group B (control group)<br>The patients in the control group will have their catheter removed according to the regular protocol of the hospital (at least 6 hours in place). | Device: Foley catheter<br>* The aim of this study is to evaluate if direct removal of the urine catheter after an LH (total laparoscopic hysterectomy and laparoscopic supracervical hysterectomy) is associated with similar (or better) outcomes compared to delayed catheter removal after surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary retention (inability to void) |  | 6 hours after removal of urinary catheter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of re-catheterisation |  | 6 hours without voiding | 
| Urinary tract infection (by performing a urine dipstick test and based on clinical symptoms) |  | Dipstick: first urine after removal of catheter (group 1: direct after OR, group 2: at least 6 hours after OR), clinical symptoms through study period (up to 6 weeks postoperative) | 
| Patient satisfaction (self-administrated questionnaire) |  | 6 hours postoperative; 24 hours and 6 weeks | 
| Visual analogue scale score (VAS score) |  | 6 hours postoperative; 24 hours |