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

NCT03280420 | Completed DMC

• 1 other identifier: 123urology
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

BPH With Urinary Obstruction

Keywords

Acute urinary retention; BPH; TWOC; Tamsulosin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Factor affecting trial without catheter

  6 Months

Study Arms (2)

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.

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.

Procedure: Late catheter removal

Interventions

Early catheter removal PROCEDURE

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.

Also known as: After 3 days catheter removal

early catheter removal

Late catheter removal PROCEDURE

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.

Also known as: After 7 days catheter removal

late catheter removal

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Salem Hassan Salem Mohamed: lead

Study Sites (1)

Faculty of medicine ,Al Azhar university

Cairo, El Mokhayam El Daem St.، Ezbet El-Arab, Nasr City, Cairo, Egypt

Location

Study Officials

• Mohamed M Badr, PHD

  Al-Azhar University

  STUDY CHAIR

• Mohamed F El Saeed El Ebiary, MD

  Al-Azhar University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Cairo, Egypt

Model Details: 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.

Study Record Dates

• First Submitted: August 12, 2017
• First Posted: September 12, 2017
• Study Start: March 12, 2017
• Primary Completion: September 16, 2017
• Study Completion: September 16, 2017
• Last Updated: September 25, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)