Does Benign Prostatic Obstruction Cause Hypertension?

Completed

• Conditions: Prostatic Hyperplasia; Hypertension
• Interventions: Procedure: 24-hr ambulatory blood pressure measurement

• Registration Number: NCT02347436
• Lead Sponsor: St. Olavs Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-16
• Study First Submitted QC: 2015-01-26
• Study First Posted: 2015-01-27
• Study Start: 2015-02
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-09
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
inguinal hernia or hydrocele	24-hr ambulatory blood pressure measurement	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
benign prostatic hypertrophy	24-hr ambulatory blood pressure measurement	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.

Primary Outcome Measures

Name	Time	Method
change in blood pressure	7,5 months	one measurement 6 weeks pre-surgery, and ambulatory measurement during 6 months post-surgery

Secondary Outcome Measures

Name	Time	Method
prostate symptom severity assessed by 'International prostate severity score' (questionnaire)	7,5 months	assessed by 'International prostate severity score' (questionnaire)

Trial Locations

Locations (1)

St Olavs Hospital, Department of Urology; 🇳🇴 Trondheim, Norway