Does Benign Prostatic Obstruction Cause Hypertension?

• Sponsor: St. Olavs Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02347436
• Collaborator: Norwegian University of Science and Technology (Other)
• Enrollment: 20
• Location: 1
• Actual Duration (Months): 56.9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Hyperplasia; Hypertension	Procedure: 24-hr ambulatory blood pressure measurement

Study Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Effect of Transurethral Prostate Resection on 24 Hour Blood Pressure Measurement
• Actual Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Oct 31, 2019
• Actual Study Completion Date: Oct 31, 2019

Arms and Interventions

Arm	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.	Procedure: 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	Procedure: 24-hr ambulatory blood pressure measurement

Outcome Measures

Primary Outcome Measures

1. change in blood pressure [7,5 months]

   one measurement 6 weeks pre-surgery, and ambulatory measurement during 6 months post-surgery

Secondary Outcome Measures

1. prostate symptom severity assessed by 'International prostate severity score' (questionnaire) [7,5 months]

   assessed by 'International prostate severity score' (questionnaire)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Olavs Hospital, Department of Urology	Trondheim		Norway

Sponsors and Collaborators

• St. Olavs Hospital
• Norwegian University of Science and Technology

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: St. Olavs Hospital
• ClinicalTrials.gov Identifier: NCT02347436
• Other Study ID Numbers: 2014/1117
• First Posted: Jan 27, 2015
• Last Update Posted: Jun 11, 2020
• Last Verified: Jun 1, 2020

• Keywords provided by St. Olavs Hospital: Transurethral Resection of Prostate
• Additional relevant MeSH terms: Prostatic Hyperplasia; Hypertension; Hyperplasia

Study Results

No Results Posted as of Jun 11, 2020