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Completed

NCT Number: NCT01705444

The Spanner Prostatic Stent and Patient's Quality of Life

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.

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Key information

Conditions

Prostatic Obstruction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Retention Urination Disorders Urogenital Diseases Urologic Diseases

Age range

45 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Princess Al-Johara Cancer Research Center, Riyadh, Saudi Arabia

Riyadh, Riyadh Region, 11541, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Foley Catheter and The Spanner Insertion

Device

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

Primary outcomes

  1. Quality of life questionnaire after using the Foley catheter

    Time frame: After five days

    Using a validated Quality of life questionnaire designed for the study

Secondary outcomes

  1. Quality of life questionnaire after using the spanner

    Time frame: After five days

    Using the same Quality of life questionnaire

Other outcomes

  1. IPSS international prostate symptom score assessment

    Time frame: After five days of using the Spanner

    Assessment of the prostate symptom score using the IPSS questionnaire five days after using the Spanner

Sponsors and collaborators

Lead sponsor

Princess Al-Johara Al-Ibrahim Cancer Research Center

Other

Registry information

Official study title

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

Acronym: SpannerQoL

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Oct 12, 2012
Registry last updated
Mar 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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