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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostatic Obstruction
• Intervention / Treatment: Device: Foley Catheter and The Spanner Insertion

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Ar Riyad
    • Riyadh, Ar Riyad, Saudi Arabia, 11541
      • Princess Al-Johara Cancer Research Center, Riyadh, Saudi Arabia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life questionnaire after using the Foley catheter	Using a validated Quality of life questionnaire designed for the study	After five days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life questionnaire after using the spanner	Using the same Quality of life questionnaire	After five days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Princess Al-Johara Al-Ibrahim Cancer Research Center
• Investigators: Principal Investigator: Danny M. Rabah, MD, Princess Al-Johara Al-Ibrahim Cancer Research Center

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: October 9, 2012
• First Submitted That Met QC Criteria: October 9, 2012
• First Posted (Estimate): October 12, 2012

Study Record Updates

• Last Update Posted (Estimate): March 31, 2016
• Last Update Submitted That Met QC Criteria: March 30, 2016
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Quality of life; Urinary retention; Foley catheter; The Spanner
• Other Study ID Numbers: E-11-541 (Other Identifier: Institutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Results will be published in per-reviewed journal