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

Princess Al-Johara Al-Ibrahim Cancer Research Center

Status: Completed

Conditions: Prostatic Obstruction

Treatments: Device: Foley Catheter and The Spanner Insertion

Study type: Interventional

Funder types: Other

Identifiers

NCT01705444

E-11-541 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: Male

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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88 participants in 1 patient group

Foley catheter and The Spanner Insertion

Other group

Description:

Quality of life questionnaire after using the Foley catheter and the Spanner

Treatment:

Device: Foley Catheter and The Spanner Insertion