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The Impact of the Temporary Stent on Parameters of Voiding Function and on the Quality of Life Among Patients With LUTS


N/A
45 Years
85 Years
Open (Enrolling)
Male
Prostatic Obstruction

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Trial Information

The Impact of the Temporary Stent on Parameters of Voiding Function and on the Quality of Life Among Patients With LUTS


This research comes up to date with technological innovations in the field of health where
investigators want to evaluate the efficacy of a new catheter (The Spanner) to reduce the
acute urinary retention and to determine whether they are consistent with the daily life of
the patient, compared to the Foley catheter previously used.

The study include all patients with acute urinary retention due to prostatic obstruction.
Subjects were excluded if they had prior surgery for prostate cancer, had any other urethral
or bladder surgery, or if they were at high risk of developing bladder or kidney stones The
study will be national community based study conducted in different hospitals in Saudi
Arabia. Investigators will test two different types of stents in patients with acute urinary
retention for a short period (not exceeding five days), find out the compatibility of these
stents with the daily life of the patient and determine their impact on his quality of life
using an appropriate questionnaire after each use.


Inclusion Criteria:



- Acute Urinary retention due to Prostatic Obstruction

Exclusion Criteria:

- Subjects were excluded if they had prior surgery for prostate cancer, had any other
urethral or bladder surgery, or if they were at high risk of developing bladder or
kidney stones

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Quality of life questionnaire after using the Foley catheter

Outcome Description:

Using a validated Quality of life questionnaire designed for the study

Outcome Time Frame:

After five days

Safety Issue:

No

Principal Investigator

Danny M. Rabah, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Al-Johara Al-Ibrahim Cancer Research Center

Authority:

Saudi Arabia: Ministry for Higher Education

Study ID:

E-11-541

NCT ID:

NCT01705444

Start Date:

March 2012

Completion Date:

June 2013

Related Keywords:

  • Prostatic Obstruction
  • Urinary retention
  • Foley catheter
  • The Spanner
  • Quality of life

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