The Spanner Prostatic Stent and Patient's Quality of Life (SpannerQoL)
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|ClinicalTrials.gov Identifier: NCT01705444|
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : March 31, 2016
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Obstruction||Device: Foley Catheter and The Spanner Insertion||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Impact of the Temporary Stent on Parameters of Voiding Function and on the Quality of Life Among Patients With LUTS|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
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.
- 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
- Quality of life questionnaire after using the spanner [ Time Frame: After five days ]Using the same Quality of life questionnaire
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705444
|Princess Al-Johara Cancer Research Center, Riyadh, Saudi Arabia|
|Riyadh, Ar Riyad, Saudi Arabia, 11541|
|Principal Investigator:||Danny M. Rabah, MD||Princess Al-Johara Al-Ibrahim Cancer Research Center|