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NCT02347436 Clinical Trial

Does Benign Prostatic Obstruction Cause Hypertension?

Hypertension Clinical Trial

Official title:
Effect of Transurethral Prostate Resection on 24 Hour Blood Pressure Measurement

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02347436
Other study ID # 2014/1117
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2015
Est. completion date October 31, 2019

Study information
Verified date June 2020
Source St. Olavs Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date October 31, 2019
Est. primary completion date October 31, 2019
Accepts healthy volunteers No
Gender Male
Age group N/A to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• 24-hr ambulatory blood pressure measurement

Locations
Country Name City State
Norway St Olavs Hospital, Department of Urology Trondheim

Sponsors (2)
Lead Sponsor Collaborator
St. Olavs Hospital Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary change in blood pressure one measurement 6 weeks pre-surgery, and ambulatory measurement during 6 months post-surgery 7,5 months
Secondary prostate symptom severity assessed by 'International prostate severity score' (questionnaire) assessed by 'International prostate severity score' (questionnaire) 7,5 months
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