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

L

Leiden University Medical Center (LUMC)

Status

Completed

Conditions

Urinary Tract Infection
Bladder Retention

Treatments

Device: Foley catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT02742636
P15.382

Details and patient eligibility

About

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).

Enrollment

162 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

162 participants in 2 patient groups

Group A (treatment group)
Experimental group
Description:
The patients in this group will have their catheter directly removed in the OR after LH.
Treatment:
Device: Foley catheter
Group B (control group)
Active Comparator group
Description:
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).
Treatment:
Device: Foley catheter

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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