Urinary Tract InfectionMUCHNCT02742636
When is the Best Moment to Remove the Urinary Catheter After Laparoscopic Hysterectomy?
A study testing Foley catheter in people with Urinary Tract Infection and Bladder Retention, run by Leiden University Medical Center at 7 sites in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Tract Infection, Bladder Retention
- What is being tested?
- Foley catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 7 sitesNetherlands
- Study dates
- 31 May 2016to 21 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years
- Scheduled for LH for benign indication or low-grade malignancy (with or without salpingo-oophorectomy)
Who cannot join
- 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 locations and contacts
7 sites in 1 country.
7 sites in 1 country
Netherlands7 sites
Reinier de Graaf Groep
Delft
Groene Hart Ziekenhuis
Gouda
Leiden University Medical Center
Leiden, North Holland, 2311 AZ
Alrijne Hospital
Leiden
Bronovo Hospital
The Hague
Haga Hospital
The Hague
Medisch Centrum Haaglanden
The Hague
About this study
Official title: When is the Best Moment to Remove the Urinary Catheter After Laparoscopic Hysterectomy: MUCH Study.
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.
Read more
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).
- Conditions
- Urinary Tract Infection, Bladder Retention
- Being tested
- Foley catheter
- Medical subject headings
- Urinary Tract Infections, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley catheterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (treatment group) | Experimental | The patients in this group will have their catheter directly removed in the OR after LH. Receives: Device: Foley catheter |
| Group B (control group) | Active comparator | 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). Receives: Device: Foley catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary retention (inability to void)
Measured: 6 hours after removal of urinary catheter
Secondary outcomes (4)
Rate of re-catheterisation
Measured: 6 hours without voiding
Urinary tract infection (by performing a urine dipstick test and based on clinical symptoms)
Measured: 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)
Measured: 6 hours postoperative; 24 hours and 6 weeks
Visual analogue scale score (VAS score)
Measured: 6 hours postoperative; 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study start31 May 2016
- Primary completion21 Jun 2017
- Study completion21 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bronovo Hospital, Haga Hospital, Alrijne Hospital, Reinier de Graaf Groep, Groene Hart Ziekenhuis, Medical Center Haaglanden
- Responsible party
- Principal investigator, FWJansen, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742636
- Sponsor's protocol ID
- P15.382
- Acronym
- MUCH
- Status last verified
- Aug 2017
- First submitted
- 1 Apr 2016
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
PubMed 34184246
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- When is the Best Moment to Remove the Urinary Catheter After Laparoscopic Hysterectomy: MUCH Study.
- ClinicalTrials.gov ID
- NCT02742636
- Acronym / sponsor ID
- MUCH / P15.382
- Conditions
- Urinary Tract Infection, Bladder Retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Bronovo Hospital, Haga Hospital, Alrijne Hospital, Reinier de Graaf Groep, Groene Hart Ziekenhuis, Medical Center Haaglanden
- Study start
- 31 May 2016 (actual)
- Primary completion
- 21 Jun 2017 (actual)
- Study completion
- 21 Jun 2017 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (treatment group) | Experimental | Device: Foley catheterThe patients in this group will have their catheter directly removed in the OR after LH. |
| Group B (control group) | Active comparator | Device: Foley catheterThe patients in the control group will have their catheter removed according to the regular protocol of the hospital (at least 6 hours in place). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Older than 18 years
- Scheduled for LH for benign indication or low-grade malignancy (with or without salpingo-oophorectomy)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foley catheterThe 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. | Device | Group A (treatment group), Group B (control group) |
Primary outcome
Urinary retention (inability to void)
Time frame: 6 hours after removal of urinary catheter
4 secondary outcomes
Rate of re-catheterisation
Time frame: 6 hours without voiding
Urinary tract infection (by performing a urine dipstick test and based on clinical symptoms)
Time frame: 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)
Time frame: 6 hours postoperative; 24 hours and 6 weeks
Visual analogue scale score (VAS score)
Time frame: 6 hours postoperative; 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Derived from this study: PubMed 34184246Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foley catheter in people with Urinary Tract Infection and Bladder Retention, run by Leiden University Medical Center at 7 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary retention (inability to void) (time frame: 6 hours after removal of urinary catheter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02742636, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2017.