Overactive Bladder SyndromeNCT02854813
Overactive Bladder in Elderly Patients- An Early Warning of Coronary Artery Disease
An observational study of Overactive Bladder Syndrome and Coronary Artery Disease, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Investigators aimed to investigate the association between over active bladder and coronary artery disease as demonstrated on coronary angiography. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Overactive Bladder Syndrome, Coronary Artery Disease
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2016to Jan 2017
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Study population: patients, whom were diagnosed to undergo coronary angiography in a center of cardiology between January 2016 and January 2017 were evaluated prospectively.
Who may be able to join
- patients, whom were diagnosed to undergo coronary angiography in a center of cardiology
Who cannot join
- a maximum flow rate of 15 ml. per second or less,
- residual volume of 100 cc or more,
- diabetes mellitus,
- neurologic disease,
- prostate or bladder cancer,
- renal failure,
Show all 9Show fewer
- urinary tract infection,
- nephrolithiasis or pelvic surgery,
- patients with a history of percutaneous coronary intervention or coronary artery bypass grafting
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Training and Research Hospital
Ankara, 06340
About this study
Investigators aimed to investigate the association between over active bladder and coronary artery disease as demonstrated on coronary angiography.
Read the detailed description
The close relationship has been demonstrated between pelvic ischemia and overactive bladder (OAB) in a study involving elderly patients. In this study, it has been found that pelvic ischemia has triggered OAB and it has been related with cardiac ischemia. The aim of this study was to delineate the correlation between OAB and the degree of coronary artery stenosis as demonstrated on coronary angiography.
- Keywords
- overactive bladder, coronary artery disease, gensini score
- Medical subject headings
- Coronary Artery Disease, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with a OAB-V8 score ≥8 | |
| Group 2 | Patients with a OAB-V8 score <8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Over active bladder V8 questionnaire score
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammet Fatih Kilinc, Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854813
- Sponsor's protocol ID
- 5192
- Status last verified
- May 2017
- First submitted
- 31 Jul 2016
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Tarcan T, Azadzoi KM, Siroky MB, Goldstein I, Krane RJ. Age-related erectile and voiding dysfunction: the role of arterial insufficiency. Br J Urol. 1998 Dec;82 Suppl 1:26-33. doi: 10.1046/j.1464-410x.1998.0820s1026.x. No abstract available.
PubMed 9883259De EJ, Hou P, Estrera AL, Sdringola S, Kramer LA, Graves DE, Westney OL. Pelvic ischemia is measurable and symptomatic in patients with coronary artery disease: a novel application of dynamic contrast-enhanced magnetic resonance imaging. J Sex Med. 2008 Nov;5(11):2635-45. doi: 10.1111/j.1743-6109.2008.00969.x. Epub 2008 Aug 26.
PubMed 18761598
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overactive Bladder in Elderly Patients- An Early Warning of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02854813
- Acronym / sponsor ID
- 5192
- Keywords
- overactive bladder, coronary artery disease, gensini score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 3 Aug 2016 (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.
Investigators aimed to investigate the association between over active bladder and coronary artery disease as demonstrated on coronary angiography.
Detailed description
The close relationship has been demonstrated between pelvic ischemia and overactive bladder (OAB) in a study involving elderly patients. In this study, it has been found that pelvic ischemia has triggered OAB and it has been related with cardiac ischemia. The aim of this study was to delineate the correlation between OAB and the degree of coronary artery stenosis as demonstrated on coronary angiography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Patients with a OAB-V8 score ≥8 |
| Group 2 | – | –Patients with a OAB-V8 score <8 |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- patients, whom were diagnosed to undergo coronary angiography in a center of cardiology between January 2016 and January 2017 were evaluated prospectively.
Key inclusion criteria (1 listed)
- patients, whom were diagnosed to undergo coronary angiography in a center of cardiology
Key exclusion criteria (9 listed)
- a maximum flow rate of 15 ml. per second or less,
- residual volume of 100 cc or more,
- diabetes mellitus,
- neurologic disease,
- prostate or bladder cancer,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Over active bladder V8 questionnaire score
Time frame: 1 week
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 May 2017.
- Background: PubMed 9883259Tarcan T, Azadzoi KM, Siroky MB, Goldstein I, Krane RJ. Age-related erectile and voiding dysfunction: the role of arterial insufficiency. Br J Urol. 1998 Dec;82 Suppl 1:26-33. doi: 10.1046/j.1464-410x.1998.0820s1026.x. No abstract available.
- Background: PubMed 18761598De EJ, Hou P, Estrera AL, Sdringola S, Kramer LA, Graves DE, Westney OL. Pelvic ischemia is measurable and symptomatic in patients with coronary artery disease: a novel application of dynamic contrast-enhanced magnetic resonance imaging. J Sex Med. 2008 Nov;5(11):2635-45. doi: 10.1111/j.1743-6109.2008.00969.x. Epub 2008 Aug 26.
- Individual participant dataSharing planned: Yes
Related trials for Overactive Bladder Syndrome
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
Tensi+ for Treating Overactive Bladder
Overactive Bladder (OAB)
Not yet recruitingObservational study
Efficacy and Safety of Peroneal Electric Transcutaneous Neuromodulation in the Real-world Clinical Practice
Overactive Bladder Syndrome
Recruiting
Improving Overactive Bladder Treatment Access and Adherence
Overactive Bladder Syndrome, Urinary Incontinence
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder Syndrome and Coronary Artery Disease, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
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 9 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 May 2017. 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 Turkey (Türkiye). 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?
Over active bladder V8 questionnaire score (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02854813, which also lists 2 linked publications.
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 May 2017.