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The Spanner Prostatic Stent and Patient's Quality of Life

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01705444
Acronym
SpannerQoL
Enrollment
88
Registered
2012-10-12
Start date
2012-03-31
Completion date
2016-03-31
Last updated
2016-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Obstruction

Keywords

Urinary retention, Foley catheter, The Spanner, Quality of life

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.

Interventions

DEVICEFoley Catheter and The Spanner Insertion

A Foley catheter will be inserted for 3-5 days, then a voiding trail will be attempted by the patient himself without the catheter. Then, the Spanner will be inserted into the same patient for another 3-5 days and an evacuation trail will be attempted also by the patient after removal of the Spanner. Treatment Satisfaction Questionnaire (TSQ) will be applied by the same person to the patient twice, once after removal of the Foley catheter and the second after removal of the Spanner.

Sponsors

Princess Al-Johara Al-Ibrahim Cancer Research Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
45 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of life questionnaire after using the Foley catheterAfter five daysUsing a validated Quality of life questionnaire designed for the study

Secondary

MeasureTime frameDescription
Quality of life questionnaire after using the spannerAfter five daysUsing the same Quality of life questionnaire

Other

MeasureTime frameDescription
IPSS international prostate symptom score assessmentAfter five days of using the SpannerAssessment of the prostate symptom score using the IPSS questionnaire five days after using the Spanner

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026