Prostatic ObstructionSpannerQoLNCT01705444
The Spanner Prostatic Stent and Patient's Quality of Life
A study testing Foley Catheter and The Spanner Insertion in people with Prostatic Obstruction, run by Princess Al-Johara Al-Ibrahim Cancer Research Center at 1 site in Saudi Arabia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 85 years, men only
- Conditions the study is for
- Prostatic Obstruction
- What is being tested?
- Foley Catheter and The Spanner Insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Mar 2012to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute Urinary retention due to Prostatic Obstruction
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Princess Al-Johara Cancer Research Center, Riyadh, Saudi Arabia
Riyadh, Riyadh Region, 11541
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostatic Obstruction
- Being tested
- Foley Catheter and The Spanner Insertion
- Keywords
- Urinary retention, Foley catheter, The Spanner, Quality of life
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley Catheter and The Spanner InsertionDevice
Also called Foley Catheter, The Spanner
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.
| Study group | Role | What they receive |
|---|---|---|
| Foley catheter and The Spanner Insertion | Other | Quality of life questionnaire after using the Foley catheter and the Spanner Receives: Device: Foley Catheter and The Spanner Insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life questionnaire after using the Foley catheter
Using a validated Quality of life questionnaire designed for the study
Measured: After five days
Secondary outcomes (1)
Quality of life questionnaire after using the spanner
Using the same Quality of life questionnaire
Measured: After five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Princess Al-Johara Al-Ibrahim Cancer Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danny M. Rabah, MD, Principal investigator, Princess Al-Johara Al-Ibrahim Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705444
- Sponsor's protocol ID
- E-11-541
- Other IDs
- E-11-541
- Acronym
- SpannerQoL
- Status last verified
- Oct 2012
- First submitted
- 9 Oct 2012
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Results will be published in per-reviewed journal
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Temporary Stent on Parameters of Voiding Function and on the Quality of Life Among Patients With LUTS
- ClinicalTrials.gov ID
- NCT01705444
- Acronym / sponsor ID
- SpannerQoL / E-11-541
- Conditions
- Prostatic Obstruction
- Keywords
- Urinary retention, Foley catheter, The Spanner, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Princess Al-Johara Al-Ibrahim Cancer Research CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 12 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Foley catheter and The Spanner Insertion | Other | Device: Foley Catheter and The Spanner InsertionQuality of life questionnaire after using the Foley catheter and the Spanner |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acute Urinary retention due to Prostatic Obstruction
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foley Catheter and The Spanner InsertionAlso: Foley Catheter, The SpannerA 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. | Device | Foley catheter and The Spanner Insertion |
Primary outcome
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
1 secondary outcome
Quality of life questionnaire after using the spanner
Time frame: After five days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
- Individual participant dataSharing planned: Yes. Results will be published in per-reviewed journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danny M. Rabah, MD principal investigator
Princess Al-Johara Al-Ibrahim Cancer Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foley Catheter and The Spanner Insertion in people with Prostatic Obstruction, run by Princess Al-Johara Al-Ibrahim Cancer Research Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life questionnaire after using the Foley catheter (time frame: After five days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2016.