Does Benign Prostatic Obstruction Cause Hypertension?

June 9, 2020 updated by: St. Olavs Hospital

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

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Trondheim, Norway
        • St Olavs Hospital, Department of Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients on the waiting list for inguinal hernia repair, hydrocele operation, or transurethral resection of the prostate, at St Olavs University Hospital, Department of Surgery, Trondheim, Norway

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Carl-Jørgen Arum, md phd, St Olavs University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

October 31, 2019

Study Completion (Actual)

October 31, 2019

Study Registration Dates

First Submitted

January 16, 2015

First Submitted That Met QC Criteria

January 26, 2015

First Posted (Estimate)

January 27, 2015

Study Record Updates

Last Update Posted (Actual)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 9, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

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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