Benign Prostatic HyperplasiaNCT03959917
TURP; Complications and Outpatient Care
An observational study of Benign Prostatic Hyperplasia, run by Umeå University at 1 site in Sweden.
Trial summary
This study aims to investigate the impact of transurethral prostate resection in regard to complications. These are direct surgical complications, such as bleeding, infection and readmissions, as well as the long term complications as incontinence and impotence. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- transurethral resection of the prostate
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 15 May 2019to 30 Sep 2020
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: This is a feasibility cohort study. All patients planned for TUR P are eligible. Patients in the ambulatory group have prostate size less than 50 cc and ASA score less less than 4 and ser under 80 years of age. This is clinical routine at the study site.
Who may be able to join
- Planned for transurethral resection of the prostate (TUR P)
Who cannot join
- No consent to participate
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Östersunds hospital
Östersund, Jämtland County, 83133
Karl-Johan Lundström, M.D, Ph.D, 004663153000, karl-johan.lundstrom@regionjh.se
Karl-Johan Lundström, karl_johan@hotmail.com
About this study
Official title: Bipolar Transurethral Resection of the Prostate; Complications and Possibility to do as Outpatient Procedure
This study aims to investigate the impact of transurethral prostate resection in regard to complications. These are direct surgical complications, such as bleeding, infection and readmissions, as well as the long term complications as incontinence and impotence. Also, the study aims to investigate if selected cases of patients could be performed as outpatient surgery, thereby reducing cost.
Read the detailed description
Transuretral prostate resection (TUR P) is a common procedure to relieve voiding problems in men. After the introduction of bipolar resection with saline, the serious complication of transurethral resection syndrome (i.e. acute hypo-natremia) has been eradicated.
The post surgical care is generally a couple of days inhospital care. The reson for this, is the risk of clot formation and in rare cases post surgical infection.
However, in selected cases, outpatient surgery has been performed with encouraging results. However, the technique has not been spread widely. The use of ambulatory surgery would reduce the direct cost of the procedure, thereby increasing it´s availability.
Also, complications in contemporary TUR P in the modern era (outside of the selected patients of clinical trials) is lacking. The information of complications that can be expected is therefore an important for patient counseling. In some studies, the use of incontinence pads after TUR P is more than 15%, which is important to reliably ascertain if this is holds true.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- transurethral resection of the prostate
- Keywords
- prostate, resection, incontinence, erectile dysfunction
- Medical subject headings
- Prostatic Hyperplasia, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transurethral resection of the prostateProcedure or surgery
Also called TUR P
Surgical removal of benign prostatic tissue
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients able to be discharged the day of surgery
Measured: One day
Proportion of patients readmitted to hospital the first day of surgery
Measured: One day
Secondary outcomes (5)
Change in IPSS score
International prostate symptom score, range 0-35
Measured: 6 months
Number of patients with cancer in surgical specimen
Pathological confirmed prostate cancer, all Gleasson Grades (6-10)
Measured: 6 months
Readmission rates within 30 days of surgery
Measured: 30 days
Complications
Clavien Dindo Classification
Measured: 30 days
Proportion catheter free
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start15 May 2019 (estimated)
- Primary completion15 Feb 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959917
- Sponsor's protocol ID
- EPN 201801-12
- Status last verified
- May 2019
- First submitted
- 21 May 2019
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bipolar Transurethral Resection of the Prostate; Complications and Possibility to do as Outpatient Procedure
- ClinicalTrials.gov ID
- NCT03959917
- Acronym / sponsor ID
- EPN 201801-12
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- prostate, resection, incontinence, erectile dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 15 May 2019 (estimated)
- Primary completion
- 15 Feb 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 22 May 2019 (actual)
- 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.
This study aims to investigate the impact of transurethral prostate resection in regard to complications. These are direct surgical complications, such as bleeding, infection and readmissions, as well as the long term complications as incontinence and impotence. Also, the study aims to investigate if selected cases of patients could be performed as outpatient surgery, thereby reducing cost.
Detailed description
Transuretral prostate resection (TUR P) is a common procedure to relieve voiding problems in men. After the introduction of bipolar resection with saline, the serious complication of transurethral resection syndrome (i.e. acute hypo-natremia) has been eradicated.
The post surgical care is generally a couple of days inhospital care. The reson for this, is the risk of clot formation and in rare cases post surgical infection.
However, in selected cases, outpatient surgery has been performed with encouraging results. However, the technique has not been spread widely. The use of ambulatory surgery would reduce the direct cost of the procedure, thereby increasing it´s availability.
Also, complications in contemporary TUR P in the modern era (outside of the selected patients of clinical trials) is lacking. The information of complications that can be expected is therefore an important for patient counseling. In some studies, the use of incontinence pads after TUR P is more than 15%, which is important to reliably ascertain if this is holds true.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a feasibility cohort study. All patients planned for TUR P are eligible. Patients in the ambulatory group have prostate size less than 50 cc and ASA score less less than 4 and ser under 80 years of age. This is clinical routine at the study site.
Key inclusion criteria (1 listed)
- Planned for transurethral resection of the prostate (TUR P)
Key exclusion criteria (1 listed)
- No consent to participate
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 |
|---|---|---|
| transurethral resection of the prostateAlso: TUR PSurgical removal of benign prostatic tissue | Procedure or surgery | – |
Primary outcome
Proportion of patients able to be discharged the day of surgery
Time frame: One day
Proportion of patients readmitted to hospital the first day of surgery
Time frame: One day
5 secondary outcomes
Change in IPSS score
Time frame: 6 months
Number of patients with cancer in surgical specimen
Time frame: 6 months
Readmission rates within 30 days of surgery
Time frame: 30 days
Complications
Time frame: 30 days
Proportion catheter free
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
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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.
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 Benign Prostatic Hyperplasia, run by Umeå University at 1 site in Sweden.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 May 2019. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients able to be discharged the day of surgery (time frame: One day). The study lists 2 primary outcomes in all. 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 24 May 2019.