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Completed

NCT Number: NCT03280420

Early Versus Late Catheter Removal in Patients With Acute Urinary Retention Secondary to BPH 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.

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Key information

Conditions

BPH With Urinary Obstruction

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine ,Al Azhar university

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: After 3 days 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.

Other names: After 7 days catheter removal

Primary outcomes

  1. 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.

Secondary outcomes

  1. Factor affecting trial without catheter

    Time frame: 6 Months

    To evaluate the role of the following in trial without catheter patient's age prostate size residual urine volume prostatic specific antigen (PSA)

Sponsors and collaborators

Lead sponsor

Salem Hassan Salem Mohamed

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 12, 2017
Registry last updated
Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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