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OpenTrials
Completed

NCT Number: NCT02347436

Does Benign Prostatic Obstruction Cause Hypertension?

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.

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Key information

Age range

Up to 65 year

Sex eligibility

Male

Study type

Observational

Primary location

St Olavs Hospital, Department of Urology

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

24-hr ambulatory blood pressure measurement

Procedure

Primary outcomes

  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 outcomes

  1. prostate symptom severity assessed by 'International prostate severity score' (questionnaire)

    Time frame: 7,5 months

    assessed by 'International prostate severity score' (questionnaire)

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Official study title

Effect of Transurethral Prostate Resection on 24 Hour Blood Pressure Measurement

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 27, 2015
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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