Early Versus Late Catheter Removal in Patients With Acute Urinary Retention Secondary to BPH Under Tamsulosin Treatment

BPH With Urinary Obstruction Clinical Trial

Official title:

Early Versus Late Catheter Removal in Patients With Acute Urinary Retention Secondary to Benign Prostatic Hyperplasia Under Tamsulosin Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03280420
• Other study ID #: 123urology
• 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
• 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.

Related Conditions & MeSH terms

• BPH With Urinary Obstruction
• Urinary Retention

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