Urinary RetentionNCT04363970
Early Removal of the Urethral Catheter Following Trans-urethral Resection of Prostate
An observational study of Urinary Retention, run by University of Jordan at 1 site in Jordan.
Trial summary
Transurethral resection of prostate is the gold standard operation for bladder outflow obstruction due to benign prostatic enlargement. However, catheter removal day is variable. Read more about this study
- Who is it for?
- Ages 45 to 90 years, men only
- Conditions the study is for
- Urinary Retention
- What is being tested?
- removal of the urinary catheter
- How many people
- 200 participants
- Where
- 1 siteJordan
- Study dates
- 30 Jun 2019to 30 Apr 2021
- Phase
- Observational
- 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 45 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: 200 adult males from urology clinic atJordan university hospital, with benign prostate hyperplasia who undergo trans-urethral resection of the prostae will be included in this study,
Who may be able to join
- All men with benign prostate hyperplasia who planned to undergo TURP will be included in this study.
Who cannot join
- Large post void residual urine.
- Simultaneous internal urethrotomy and TURP.
- Uncontrolled Diabetes Mellitus (DM).
- Cerebrovascular accident accident (CVA).
- Spinal cord injury.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Versus Delayed Removal of the Urethral Catheter After Trans Urethral, Randomized Clinical Trial.
Transurethral resection of prostate is the gold standard operation for bladder outflow obstruction due to benign prostatic enlargement. However, catheter removal day is variable. The objective of this study is to compare early and delayed catheter removal groups in terms of, urinary retention after catheter removal, length of hospital stay, weight of resected prostate, duration of resection, peri-operative blood transfusion, and postoperative complications.
Read the detailed description
This randomized controlled trial will carried out in Urology clinic at Jordan university hospital. Patients with benign prostate hyperplasia will be selected by simple random sampling technique after taking informed consent and will divided into two groups: Group A- early catheter removal group( catheter removed after 24 hours) and Group B-delayed catheter removal group ( catheter removed after 48 hours). in this study we will exclude patients with large post-void urine volume, simultaneous internal urethrotomy and transurethral resection of prostate, co-morbidity( diabetes mellitus, CVA) spinal cord injury, urethral stricture, prostate cancer proved by biopsy and intra-operative complications. Patients will discharged after removal of catheter if they voided successfully.
- Conditions
- Urinary Retention
- Being tested
- removal of the urinary catheter
- Keywords
- Benign Prostate Hyperplasia, Urinary retention, Re-catheterization
- Medical subject headings
- Urinary Retention, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
removal of the urinary catheterOther
in group A, we will remove the catheter after 24 h. In group B, we will remove the catheter after 48 h.
| Study group | Role | What they receive |
|---|---|---|
| group A- early catheter removal) | in group A, we will remove the catheter after 24 h. Receives: Other: removal of the urinary catheter | |
| Group B- delayed catheter removal | In group B, we will remove the catheter after 48 h. Receives: Other: removal of the urinary catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary retention
inability to void
Measured: after 3 months.
Secondary outcomes (1)
Lower urinary tract symptoms
urinary symptoms after the procedure.
Measured: after 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start30 Jun 2019
- Primary completion30 Apr 2020
- Study completion30 Apr 2021
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 RetentionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saddam Al Demour, University of Jordan
- Investigators
- Saddam Al Demour, MD, Principal investigator, Jordan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363970
- Sponsor's protocol ID
- sad2020
- Status last verified
- Aug 2021
- First submitted
- 16 Apr 2020
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Demour SA, Al-Zubi MT, Ababneh M, Al-Rawashdah SF, Ahmad M. A randomized clinical trial: timing of indwelling urethral catheter removal following transurethral resection of prostate. Future Sci OA. 2024 May 20;10(1):FSO927. doi: 10.2144/fsoa-2023-0195. eCollection 2024.
PubMed 38827798
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Delayed Removal of the Urethral Catheter After Trans Urethral, Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04363970
- Acronym / sponsor ID
- sad2020
- Conditions
- Urinary Retention
- Keywords
- Benign Prostate Hyperplasia, Urinary retention, Re-catheterization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 30 Jun 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 27 Apr 2020 (actual)
- 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.
Transurethral resection of prostate is the gold standard operation for bladder outflow obstruction due to benign prostatic enlargement. However, catheter removal day is variable. The objective of this study is to compare early and delayed catheter removal groups in terms of, urinary retention after catheter removal, length of hospital stay, weight of resected prostate, duration of resection, peri-operative blood transfusion, and postoperative complications.
Detailed description
This randomized controlled trial will carried out in Urology clinic at Jordan university hospital. Patients with benign prostate hyperplasia will be selected by simple random sampling technique after taking informed consent and will divided into two groups: Group A- early catheter removal group( catheter removed after 24 hours) and Group B-delayed catheter removal group ( catheter removed after 48 hours). in this study we will exclude patients with large post-void urine volume, simultaneous internal urethrotomy and transurethral resection of prostate, co-morbidity( diabetes mellitus, CVA) spinal cord injury, urethral stricture, prostate cancer proved by biopsy and intra-operative complications. Patients will discharged after removal of catheter if they voided successfully.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A- early catheter removal) | – | Other: removal of the urinary catheterin group A, we will remove the catheter after 24 h. |
| Group B- delayed catheter removal | – | Other: removal of the urinary catheterIn group B, we will remove the catheter after 48 h. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 200 adult males from urology clinic atJordan university hospital, with benign prostate hyperplasia who undergo trans-urethral resection of the prostae will be included in this study,
Key inclusion criteria (1 listed)
- All men with benign prostate hyperplasia who planned to undergo TURP will be included in this study.
Key exclusion criteria (5 listed)
- Large post void residual urine.
- Simultaneous internal urethrotomy and TURP.
- Uncontrolled Diabetes Mellitus (DM).
- Cerebrovascular accident accident (CVA).
- Spinal cord injury.
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 |
|---|---|---|
| removal of the urinary catheterin group A, we will remove the catheter after 24 h. In group B, we will remove the catheter after 48 h. | Other | Group B- delayed catheter removal, group A- early catheter removal) |
Primary outcome
urinary retention
Time frame: after 3 months.
inability to void
1 secondary outcome
Lower urinary tract symptoms
Time frame: after 3 months.
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 20 Aug 2021.
- Derived from this study: PubMed 38827798Demour SA, Al-Zubi MT, Ababneh M, Al-Rawashdah SF, Ahmad M. A randomized clinical trial: timing of indwelling urethral catheter removal following transurethral resection of prostate. Future Sci OA. 2024 May 20;10(1):FSO927. doi: 10.2144/fsoa-2023-0195. eCollection 2024.
- 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.
Saddam Al Demour, MD principal investigator
Jordan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Retention, run by University of Jordan at 1 site in Jordan.
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 1 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 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. 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 (time frame: after 3 months.). 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 NCT04363970, 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 20 Aug 2021.