- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02347436
Does Benign Prostatic Obstruction Cause Hypertension?
Effect of Transurethral Prostate Resection on 24 Hour Blood Pressure Measurement
The known correlation between benign prostatic hypertrophy (BPH) and hypertension could be explained by 3 theoretical pathway models. Whether hypertension causes BPH, BPH causes hypertension or the two are caused by a common factor is currently unknown.
In this study it will be investigated whether hypertension is due to the direct effects of infravesical obstruction to urinary outflow in patients with benign prostatic hyperplasia. The approach will be blood pressure measurement in patients who will have a resection of the prostate.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Trondheim, Norway
- St Olavs Hospital, Department of Urology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Listed for inguinal hernia repair or hydrocele repair or transurethral resection of the prostate
- signed informed consent
Exclusion Criteria:
- Treatment with antihypertensive medication that has been started within 3 months of inclusion.
- Treatment with antihypertensive medication that has been started after inclusion and before final blood pressure measurements have been obtained 6 months after operation.
- Any reason that the investigator deems that the participant will not comply with follow-up.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
benign prostatic hypertrophy
patients who are diagnosed with lower urinary tract symptoms caused by prostatic hypertrophy, undergo transurethral resection of the prostate, and post-surgery 24-hr ambulatory blood pressure measurement.
|
|
inguinal hernia or hydrocele
patients who are diagnosed with lower urinary tract symptoms caused by inguinal hernia or hydrocele, undergo surgical inguinal hernia repair or hydrocele repair, and post-surgery 24-hr ambulatory blood pressure measurement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in blood pressure
Time Frame: 7,5 months
|
one measurement 6 weeks pre-surgery, and ambulatory measurement during 6 months post-surgery
|
7,5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prostate symptom severity assessed by 'International prostate severity score' (questionnaire)
Time Frame: 7,5 months
|
assessed by 'International prostate severity score' (questionnaire)
|
7,5 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Carl-Jørgen Arum, md phd, St Olavs University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/1117
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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