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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03280420
Other study ID # 123urology
Secondary ID
Status Completed
Phase N/A
First received August 12, 2017
Last updated September 20, 2017
Start date March 12, 2017
Est. completion date September 16, 2017

Study information

Verified date September 2017
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 16, 2017
Est. primary completion date September 16, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients having first attack of acute urinary retention secondary to BPH.

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Early 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 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.

Locations

Country Name City State
Egypt Faculty of medicine ,Al Azhar university Cairo El Mokhayam El Daem st.? Ezbet El-Arab, Nasr City, Cairo

Sponsors (1)

Lead Sponsor Collaborator
Salem Hassan Salem Mohamed

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 Months
Secondary 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) 6 Months
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