The Spanner Prostatic Stent and Patient's Quality of Life (SpannerQoL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Princess Al-Johara Al-Ibrahim Cancer Research Center
Sponsor:
Information provided by (Responsible Party):
Princess Al-Johara Al-Ibrahim Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01705444
First received: October 9, 2012
Last updated: November 5, 2013
Last verified: October 2012
  Purpose

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.


Condition Intervention
Prostatic Obstruction
Device: Foley Catheter and The Spanner Insertion

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of the Temporary Stent on Parameters of Voiding Function and on the Quality of Life Among Patients With LUTS

Further study details as provided by Princess Al-Johara Al-Ibrahim Cancer Research Center:

Primary Outcome Measures:
  • Quality of life questionnaire after using the Foley catheter [ Time Frame: After five days ] [ Designated as safety issue: No ]
    Using a validated Quality of life questionnaire designed for the study


Secondary Outcome Measures:
  • Quality of life questionnaire after using the spanner [ Time Frame: After five days ] [ Designated as safety issue: No ]
    Using the same Quality of life questionnaire


Other Outcome Measures:
  • IPSS international prostate symptom score assessment [ Time Frame: After five days of using the Spanner ] [ Designated as safety issue: No ]
    Assessment of the prostate symptom score using the IPSS questionnaire five days after using the Spanner


Estimated Enrollment: 88
Study Start Date: March 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Foley catheter and The Spanner Insertion
Quality of life questionnaire after using the Foley catheter and the Spanner
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.
Other Names:
  • Foley Catheter
  • The Spanner

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

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01705444

Contacts
Contact: Karim H. Farhat, PhD 00966568237271 farhatscience@yahoo.fr

Locations
Saudi Arabia
Princess Al-Johara Cancer Research Center, Riyadh, Saudi Arabia Recruiting
Riyadh, Ar Riyad, Saudi Arabia, 11541
Contact: Kadrim H. Farhat, PhD    966568237271      
Principal Investigator: Danny M. Rabah, MD         
Sponsors and Collaborators
Princess Al-Johara Al-Ibrahim Cancer Research Center
Investigators
Principal Investigator: Danny M. Rabah, MD Princess Al-Johara Al-Ibrahim Cancer Research Center
  More Information

No publications provided

Responsible Party: Princess Al-Johara Al-Ibrahim Cancer Research Center
ClinicalTrials.gov Identifier: NCT01705444     History of Changes
Other Study ID Numbers: E-11-541, E-11-541
Study First Received: October 9, 2012
Last Updated: November 5, 2013
Health Authority: Saudi Arabia: Ministry for Higher Education

Keywords provided by Princess Al-Johara Al-Ibrahim Cancer Research Center:
Urinary retention
Foley catheter
The Spanner
Quality of life

ClinicalTrials.gov processed this record on August 27, 2014