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Does Benign Prostatic Obstruction Cause Hypertension?

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ClinicalTrials.gov Identifier: NCT02347436
Recruitment Status : Recruiting
First Posted : January 27, 2015
Last Update Posted : February 28, 2017
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Prostatic Hyperplasia Hypertension Procedure: 24-hr ambulatory blood pressure measurement

Study Type : Observational
Estimated Enrollment : 80 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 : February 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.
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



Primary Outcome Measures :
  1. change in blood pressure [ Time Frame: 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) [ Time Frame: 7,5 months ]
    assessed by 'International prostate severity score' (questionnaire)



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Ages Eligible for Study:   up to 65 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02347436


Contacts
Contact: Carl-Jørgen Arum, md phd +47 72571148 carl-jorgen.arum@ntnu.no
Contact: Yasja Johari, md +47 72825575 yasha.johari@stolav.no

Locations
Norway
St Olavs Hospital, Department of Urology Recruiting
Trondheim, Norway
Contact: Yasha Johari, md       yasha.johari@stolav.no   
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
Principal Investigator: Carl-Jørgen Arum, md phd St Olavs University Hospital

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT02347436     History of Changes
Other Study ID Numbers: 2014/1117
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017

Keywords provided by St. Olavs Hospital:
Transurethral Resection of Prostate

Additional relevant MeSH terms:
Hypertension
Hyperplasia
Prostatic Hyperplasia
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male