The Spanner Prostatic Stent and Patient's Quality of Life

Prostatic Obstruction Clinical Trial

— SpannerQoL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01705444
• Other study ID #: E-11-541
• Secondary ID: E-11-541
• Status: Completed
• Phase: N/A
• First received: October 9, 2012
• Last updated: March 30, 2016
• Start date: March 2012
• Est. completion date: March 2016

Study information

• Verified date: October 2012
• Source: Princess Al-Johara Al-Ibrahim Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry for Higher Education
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 85 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Prostatic Obstruction

Intervention

Device:
• Foley 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.

Locations

Country	Name	City	State
Saudi Arabia	Princess Al-Johara Cancer Research Center, Riyadh, Saudi Arabia	Riyadh	Ar Riyad

Sponsors (1)

Lead Sponsor	Collaborator
Princess Al-Johara Al-Ibrahim Cancer Research Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	IPSS international prostate symptom score assessment	Assessment of the prostate symptom score using the IPSS questionnaire five days after using the Spanner	After five days of using the Spanner	No
Primary	Quality of life questionnaire after using the Foley catheter	Using a validated Quality of life questionnaire designed for the study	After five days	No
Secondary	Quality of life questionnaire after using the spanner	Using the same Quality of life questionnaire	After five days	No