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

Primary Purpose

BPH With Urinary Obstruction

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Early catheter removal
Late catheter removal
Sponsored by
Salem Hassan Salem Mohamed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for BPH With Urinary Obstruction focused on measuring Acute urinary retention, BPH, TWOC, Tamsulosin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of medicine ,Al Azhar university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

early catheter removal

late catheter removal

Arm Description

30 patients will receive Tamsulosin hydrochloride 0.4 mg once daily and the catheter will be removed after 3 days.

30 patients will receive Tamsulosin hydrochloride 0.4 mg once daily and the catheter will be removed after 7 days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

First Posted
August 12, 2017
Last Updated
September 20, 2017
Sponsor
Salem Hassan Salem Mohamed
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1. Study Identification

Unique Protocol Identification Number
NCT03280420
Brief Title
Early Versus Late Catheter Removal in Patients With Acute Urinary Retention Secondary to BPH Under Tamsulosin Treatment
Official Title
Early Versus Late Catheter Removal in Patients With Acute Urinary Retention Secondary to Benign Prostatic Hyperplasia Under Tamsulosin Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
March 12, 2017 (Actual)
Primary Completion Date
September 16, 2017 (Actual)
Study Completion Date
September 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Salem Hassan Salem Mohamed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BPH With Urinary Obstruction
Keywords
Acute urinary retention, BPH, TWOC, Tamsulosin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
early catheter removal
Arm Type
Active Comparator
Arm Description
30 patients will receive Tamsulosin hydrochloride 0.4 mg once daily and the catheter will be removed after 3 days.
Arm Title
late catheter removal
Arm Type
Active Comparator
Arm Description
30 patients will receive Tamsulosin hydrochloride 0.4 mg once daily and the catheter will be removed after 7 days.
Intervention Type
Procedure
Intervention Name(s)
Early catheter removal
Other Intervention Name(s)
After 3 days catheter removal
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Late catheter removal
Other Intervention Name(s)
After 7 days catheter removal
Intervention Description
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.
Primary Outcome Measure Information:
Title
The duration for trial without catheter
Description
To determine the optimum period to remove catheter in patients complaining of acute urinary retention with benign prostatic hyperplasia.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Factor affecting trial without catheter
Description
To evaluate the role of the following in trial without catheter patient's age prostate size residual urine volume prostatic specific antigen (PSA)
Time Frame
6 Months

10. Eligibility

Sex
Male
Gender Based
Yes
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed M Badr, PHD
Organizational Affiliation
Al-Azhar University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mohamed F El Saeed El Ebiary, MD
Organizational Affiliation
Al-Azhar University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of medicine ,Al Azhar university
City
Cairo
State/Province
El Mokhayam El Daem St.، Ezbet El-Arab, Nasr City, Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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