Clinical trial NCT01705444: The Spanner Prostatic Stent and Patient's Quality of Life
Official title: The Impact of the Temporary Stent on Parameters of Voiding Function and on the Quality of Life Among Patients With LUTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Obstruction
Keywords: Urinary retention
Foley catheter
The Spanner
Quality of life
Lead sponsor: Princess Al-Johara Al-Ibrahim Cancer Research Center
Sponsor class: OTHER
First posted: 2012-10-12
Enrollment: 88
Sex: MALE
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life questionnaire after using the Foley catheter
timeFrame: After five days
Secondary outcomes:
measure: Quality of life questionnaire after using the spanner
timeFrame: After five days
Other outcomes:
measure: IPSS international prostate symptom score assessment
timeFrame: After five days of using the Spanner
Locations:
city: Riyadh
country: Saudi Arabia
facility: Princess Al-Johara Cancer Research Center, Riyadh, Saudi Arabia
state: Ar Riyad
Study officials:
affiliation: Princess Al-Johara Al-Ibrahim Cancer Research Center
name: Danny M. Rabah, MD
role: PRINCIPAL_INVESTIGATOR
References: