BPH With Urinary ObstructionNCT03280420
Early Versus Late Catheter Removal in Patients With Acute Urinary Retention Secondary to BPH Under Tamsulosin Treatment
A study testing Early catheter removal and Late catheter removal in people with BPH With Urinary Obstruction, run by Salem Hassan Salem Mohamed at 1 site in Egypt.
Trial summary
The aim of this work is to compare between early (3days) and late(7days) removal of urinary catheter after acute urine retention in patients with Benign Prostatic Hyperplasia under Tamsulosin treatment. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- BPH With Urinary Obstruction
- What is being tested?
- Early catheter removal and Late catheter removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Mar 2017to 16 Sep 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients having first attack of acute urinary retention secondary to BPH.
Who cannot join
- Renal impairment.
- Suspected urethral stricture.
- Neurogenic bladder.
- Cancer prostate.
- Medically induced retention.
- Previous use of alpha blockers.
- History of drug hypersensitivity or allergy to Tamsulosin.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of medicine ,Al Azhar university
Cairo, El Mokhayam El Daem St.، Ezbet El-Arab, Nasr City, Cairo
About this study
Official title: Early Versus Late Catheter Removal in Patients With Acute Urinary Retention Secondary to Benign Prostatic Hyperplasia Under Tamsulosin Treatment
The aim of this work is to compare between early (3days) and late(7days) removal of urinary catheter after acute urine retention in patients with Benign Prostatic Hyperplasia under Tamsulosin treatment.
Read the detailed description
This is a prospective randomized study, Men with acute urinary retention secondary to benign prostatic hyperplasia were catheterized and then, if they fulfilled the entry criteria, were randomly assigned to receive 0.4 mg tamsulosin hydrochloride for three days or seven days, After that the catheter was removed and the ability to void unaided assessed.
- Conditions
- BPH With Urinary Obstruction
- Being tested
- Early catheter removal, Late catheter removal
- Keywords
- Acute urinary retention, BPH, TWOC, Tamsulosin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early catheter removalProcedure or surgery
Also called After 3 days catheter removal
Patients will receive selective alpha blocker ( tamsulosin 0.4mg ) once daily and the catheter will be removed after 3 days.
After catheter removal, patients will be allowed to void and will be discharged home who will have a successful void more than 200 cc of urine. Patients who will fail to void will be re-catheterized and will be prepared for prostatectomy.
Late catheter removalProcedure or surgery
Also called After 7 days catheter removal
Patients will receive selective alpha blocker ( tamsulosin 0.4mg ) once daily and the catheter will be removed after 7 days.
After catheter removal, patients will be allowed to void and will be discharged home who will have a successful void more than 200 cc of urine. Patients who will fail to void will be re-catheterized and will be prepared for prostatectomy.
| Study group | Role | What they receive |
|---|---|---|
| early catheter removal | Active comparator | 30 patients will receive Tamsulosin hydrochloride 0.4 mg once daily and the catheter will be removed after 3 days. Receives: Procedure: Early catheter removal |
| late catheter removal | Active comparator | 30 patients will receive Tamsulosin hydrochloride 0.4 mg once daily and the catheter will be removed after 7 days. Receives: Procedure: Late catheter removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration for trial without catheter
To determine the optimum period to remove catheter in patients complaining of acute urinary retention with benign prostatic hyperplasia.
Measured: 6 Months
Secondary outcomes (1)
Factor affecting trial without catheter
To evaluate the role of the following in trial without catheter patient's age prostate size residual urine volume prostatic specific antigen (PSA)
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start12 Mar 2017
- Primary completion16 Sep 2017
- Study completion16 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPH With Urinary ObstructionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients were catheterized and received urinary antiseptic and then randomly divided into two groups : Group I :30 patients received Tamsulosin 0.4 mg once daily and catheter removed after 3 days. Group II :30 patients received Tamsulosin 0.4 mg once daily and catheter removed after 7 days.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salem Hassan Salem Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Salem Hassan Salem Mohamed, Al-Azhar University
- Investigators
- Mohamed M Badr, PHD, Study chair, Al-Azhar UniversityMohamed F El Saeed El Ebiary, MD, Study director, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280420
- Sponsor's protocol ID
- 123urology
- Status last verified
- Sep 2017
- First submitted
- 12 Aug 2017
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late Catheter Removal in Patients With Acute Urinary Retention Secondary to Benign Prostatic Hyperplasia Under Tamsulosin Treatment
- ClinicalTrials.gov ID
- NCT03280420
- Acronym / sponsor ID
- 123urology
- Conditions
- BPH With Urinary Obstruction
- Keywords
- Acute urinary retention, BPH, TWOC, Tamsulosin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Salem Hassan Salem MohamedUniversity, hospital or other
- Study start
- 12 Mar 2017 (actual)
- Primary completion
- 16 Sep 2017 (actual)
- Study completion
- 16 Sep 2017 (actual)
- First posted
- 12 Sep 2017 (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.
The aim of this work is to compare between early (3days) and late(7days) removal of urinary catheter after acute urine retention in patients with Benign Prostatic Hyperplasia under Tamsulosin treatment.
Detailed description
This is a prospective randomized study, Men with acute urinary retention secondary to benign prostatic hyperplasia were catheterized and then, if they fulfilled the entry criteria, were randomly assigned to receive 0.4 mg tamsulosin hydrochloride for three days or seven days, After that the catheter was removed and the ability to void unaided assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients were catheterized and received urinary antiseptic and then randomly divided into two groups : Group I :30 patients received Tamsulosin 0.4 mg once daily and catheter removed after 3 days. Group II :30 patients received Tamsulosin 0.4 mg once daily and catheter removed after 7 days.
| Arm | Type | Receives |
|---|---|---|
| early catheter removal | Active comparator | Procedure: Early catheter removal30 patients will receive Tamsulosin hydrochloride 0.4 mg once daily and the catheter will be removed after 3 days. |
| late catheter removal | Active comparator | Procedure: Late catheter removal30 patients will receive Tamsulosin hydrochloride 0.4 mg once daily and the catheter will be removed after 7 days. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients having first attack of acute urinary retention secondary to BPH.
Key exclusion criteria (7 listed)
- Renal impairment.
- Suspected urethral stricture.
- Neurogenic bladder.
- Cancer prostate.
- Medically induced retention.
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 |
|---|---|---|
| Early catheter removalAlso: After 3 days catheter removalPatients will receive selective alpha blocker ( tamsulosin 0.4mg ) once daily and the catheter will be removed after 3 days. After catheter removal, patients will be allowed to void and will be discharged home who will have a successful void more than 200 cc of urine. Patients who will fail to void will be re-catheterized and will be prepared for prostatectomy. | Procedure or surgery | early catheter removal |
| Late catheter removalAlso: After 7 days catheter removalPatients will receive selective alpha blocker ( tamsulosin 0.4mg ) once daily and the catheter will be removed after 7 days. After catheter removal, patients will be allowed to void and will be discharged home who will have a successful void more than 200 cc of urine. Patients who will fail to void will be re-catheterized and will be prepared for prostatectomy. | Procedure or surgery | late catheter removal |
Primary outcome
The duration for trial without catheter
Time frame: 6 Months
To determine the optimum period to remove catheter in patients complaining of acute urinary retention with benign prostatic hyperplasia.
1 secondary outcome
Factor affecting trial without catheter
Time frame: 6 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 25 Sep 2017.
- 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.
Mohamed M Badr, PHD study chair
Al-Azhar University
Mohamed F El Saeed El Ebiary, MD study director
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early catheter removal and Late catheter removal in people with BPH With Urinary Obstruction, run by Salem Hassan Salem Mohamed at 1 site in Egypt.
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 7 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 25 Sep 2017. 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 Egypt. 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?
The duration for trial without catheter (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2017.