Prostatic HyperplasiaNCT02347436
Does Benign Prostatic Obstruction Cause Hypertension?
An observational study of Prostatic Hyperplasia and Hypertension, run by St. Olavs Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages Up to 65 years, men only
- Conditions the study is for
- Prostatic Hyperplasia, Hypertension
- What is being tested?
- 24-hr ambulatory blood pressure measurement
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2015to 31 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Listed for inguinal hernia repair or hydrocele repair or transurethral resection of the prostate
- signed informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Transurethral Prostate Resection on 24 Hour Blood Pressure Measurement
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.
- Conditions
- Prostatic Hyperplasia, Hypertension
- Being tested
- 24-hr ambulatory blood pressure measurement
- Keywords
- Transurethral Resection of Prostate
- Medical subject headings
- Prostatic Hyperplasia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24-hr ambulatory blood pressure measurementProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: 24-hr ambulatory blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in blood pressure
one measurement 6 weeks pre-surgery, and ambulatory measurement during 6 months post-surgery
Measured: 7,5 months
Secondary outcomes (1)
prostate symptom severity assessed by 'International prostate severity score' (questionnaire)
assessed by 'International prostate severity score' (questionnaire)
Measured: 7,5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Carl-Jørgen Arum, md phd, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347436
- Sponsor's protocol ID
- 2014/1117
- Status last verified
- Jun 2020
- First submitted
- 16 Jan 2015
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transurethral Prostate Resection on 24 Hour Blood Pressure Measurement
- ClinicalTrials.gov ID
- NCT02347436
- Acronym / sponsor ID
- 2014/1117
- Conditions
- Prostatic Hyperplasia, Hypertension
- Keywords
- Transurethral Resection of Prostate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- Feb 2015 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| benign prostatic hypertrophy | – | Procedure: 24-hr ambulatory blood pressure measurementpatients 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. |
| inguinal hernia or hydrocele | – | Procedure: 24-hr ambulatory blood pressure measurementpatients 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 |
Who may qualify
- Ages
- Up to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Listed for inguinal hernia repair or hydrocele repair or transurethral resection of the prostate
- signed informed consent
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24-hr ambulatory blood pressure measurement | Procedure or surgery | benign prostatic hypertrophy, inguinal hernia or hydrocele |
Primary outcome
change in blood pressure
Time frame: 7,5 months
one measurement 6 weeks pre-surgery, and ambulatory measurement during 6 months post-surgery
1 secondary outcome
prostate symptom severity assessed by 'International prostate severity score' (questionnaire)
Time frame: 7,5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
Related trials for Prostatic Hyperplasia
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Not yet recruitingPhase 3
Efficacy and Safety of Two Fixed-dose Combinations in Men With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia. (BENIPRO)
Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release During Holmium Laser Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Active, not recruitingPhase 2
Effects of EPA on Prostate Cancer Cells Proliferation and Quality of Life
Prostate Cancer
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl-Jørgen Arum, md phd principal investigator
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Hyperplasia and Hypertension, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in blood pressure (time frame: 7,5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.