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CompletedNCT03280420Updated Sep 25, 2017

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

An interventional study of Early catheter removal and Late catheter removal in BPH With Urinary Obstruction, sponsored by Salem Hassan Salem Mohamed. Completed at 1 site in Egypt. Open to male participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-25.

Sponsored by Salem Hassan Salem Mohamed · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • BPH With Urinary Obstruction

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Keywords

  • Acute urinary retention
  • BPH
  • TWOC
  • Tamsulosin
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    early catheter removal

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

    Procedure: Early catheter removal

  • Active comparator
    late catheter removal

    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

  • ProcedureEarly 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.

    Also known as: After 3 days catheter removal

  • ProcedureLate 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.

    Also known as: After 7 days catheter removal

05

What researchers measure

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.

    Time frame: 6 Months

Secondary outcomes

  1. 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)

    Time frame: 6 Months

06

Study locations

1 site
  • Faculty of medicine ,Al Azhar university
    Cairo, El Mokhayam El Daem St.، Ezbet El-Arab, Nasr City, Cairo, Egypt
07

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 10, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03280420
Lead sponsor
Salem Hassan Salem Mohamed
Responsible party
Salem Hassan Salem Mohamed (Cairo, Egypt, Al-Azhar University) — Sponsor-investigator
First posted
Sep 12, 2017
Start date
Mar 12, 2017
Primary completion
Sep 16, 2017
Completion
Sep 16, 2017
Last update
Sep 25, 2017

Study contacts

Mohamed M Badr, PHD
study chair · Al-Azhar University
Mohamed F El Saeed El Ebiary, MD
study director · Al-Azhar University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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