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The Spanner Prostatic Stent and Patient's Quality of Life

Not Applicable
Completed
Conditions
Prostatic Obstruction
Interventions
Device: Foley Catheter and The Spanner Insertion
Registration Number
NCT01705444
Lead Sponsor
Princess Al-Johara Al-Ibrahim Cancer Research Center
Brief Summary

Acute urinary retention is considered one of the most common problems in the older age, especially those who have benign prostatic hyperplasia. Solving the problem of acute urinary retention using the Foley catheter still causes problems at the level of patient movement and the daily exercises. However, with the emergence of a new device, the spanner, investigators believe that many of the above mentioned problems can be resolved. This tool may provide more freedom for the patient.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
88
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Foley catheter and The Spanner InsertionFoley Catheter and The Spanner InsertionQuality of life questionnaire after using the Foley catheter and the Spanner
Primary Outcome Measures
NameTimeMethod
Quality of life questionnaire after using the Foley catheterAfter five days

Using a validated Quality of life questionnaire designed for the study

Secondary Outcome Measures
NameTimeMethod
Quality of life questionnaire after using the spannerAfter five days

Using the same Quality of life questionnaire

Trial Locations

Locations (1)

Princess Al-Johara Cancer Research Center, Riyadh, Saudi Arabia

🇸🇦

Riyadh, Ar Riyad, Saudi Arabia

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