NCT02854813

Brief Summary

Investigators aimed to investigate the association between over active bladder and coronary artery disease as demonstrated on coronary angiography.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

July 31, 2016

Last Update Submit

May 29, 2017

Conditions

Keywords

overactive bladdercoronary artery diseasegensini score

Outcome Measures

Primary Outcomes (1)

  • Over active bladder V8 questionnaire score

    1 week

Study Arms (2)

Group 1

Patients with a OAB-V8 score ≥8

Group 2

Patients with a OAB-V8 score \<8

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients, whom were diagnosed to undergo coronary angiography in a center of cardiology between January 2016 and January 2017 were evaluated prospectively.

You may qualify if:

  • patients, whom were diagnosed to undergo coronary angiography in a center of cardiology

You may not qualify if:

  • 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,
  • urinary tract infection,
  • nephrolithiasis or pelvic surgery,
  • patients with a history of percutaneous coronary intervention or coronary artery bypass grafting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Training and Research Hospital

Ankara, 06340, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 9883259BACKGROUND
  • De 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.

    PMID: 18761598BACKGROUND

MeSH Terms

Conditions

Coronary Artery DiseaseUrinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

July 31, 2016

First Posted

August 3, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

May 31, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will share

Locations