Benign Prostatic HyperplasiaNCT06852859
Patient-reported Pain and Symptom Relief During Three Months After Surgery for Benign Prostatic Hyperplasia
An observational study of Benign Prostatic Hyperplasia, run by Sahlgrenska University Hospital at 3 sites in Sweden.
Trial summary
This is a prospective observational study in patients undergoing surgery for benign prostatic hyperplasia (BPH). The purpose of the study is to investigate in great detail patients' recovery after surgery for BPH regarding pain, hematuria, urine leakage and use of pain-relieving medications for three months… Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Transurethral resection of the prostate, Transurethral vaporization of the prostate and GreenLight laser enucleation of the prostate
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 3 sitesSweden
- Study dates
- 15 Mar 2025to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for surgery for benign prostatic hyperplasia
Who may be able to join
- Patients undergoing transurethral surgery for benign prostatic hyperplasia
- Singed informed consent to participate
Who cannot join
- Non-swedish speaking patients
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden3 sites, 3 recruiting
- Recruiting
Alingsås lasarett, department of general surgery, urology and orthopaedic surgery
Alingsås
- Not yet recruiting
Kungälvs sjukhus, department of urology
Kungälv
- Not yet recruiting
NU sjukvården, Uddevalla sjukhus, department of urology
Uddevalla
About this study
Official title: Patient-reported Pain and Symptom Relief During Three Months After Surgery for Benign Prostatic Hyperplasia.
This is a prospective observational study in patients undergoing surgery for benign prostatic hyperplasia (BPH).
The purpose of the study is to investigate in great detail patients' recovery after surgery for BPH regarding pain, hematuria, urine leakage and use of pain-relieving medications for three months postoperatively. Patient-reported outcomes after three different surgical methods will be investigated: transurethral resection, transurethral vaporization and laser transurethral enucleation of the prostate (Green-LEP)
Read more
Research questions:
- How do patients rate their day-to-day pain during the first three months after surgery for BPH? How long does it take to be pain free?
- How does the patient estimate any day-to-day burning sensation during the first three months after surgery for BPH?
- How many painkilling tablets of a certain preparation and a certain strength take patients per day in the first three months after surgery for BPH?
- How long do patients have urinary leakage after surgery for BPH?
- Are the patients bothered by possible urine leakage and if so for how long after surgery for BPH?
- How long does one have macroscopic hematuria after surgery for BPH?
- How quickly are the patients' urinary tract problems affected according to the IPSS per month?
- Are the results on the above outcome measures different between the three TUR-P methods, TUV-P and Green LEP?
Read the detailed description
Design and selection:
This is a prospective multicenter observational study in which patients undergoing TUR-P, TUV-P and GreenLEP for BPH are included. The subjects will be followed up with a self-assessment form that is completed daily for three months and then sent to the responsible researchers. After this, the research subjects will be followed up with sent out IPSS forms after six months, and then annually for up to five years. These are sent in stamped envelopes.
Participants:
The study will include 500 patients who undergo surgery for BPH at Alingsås hospital, Sjukhusen i Väster and Sahlgrenska University Hospital, as well as possibly an additional urology clinic in the future. The inclusion criteria include men over 50 years of age with diagnosed BPH and LUTS who have an indication for surgery with any of the three methods studied.
Outcome measures:
- Pain and burning will be assessed using the NRS (numeric scale) between 0 and 10 where 0 is defined as "no pain/burning" and 10 is defined as "worst imaginable pain/burning". The researchers fill in this day-by-day for three months
- Use of pain-relieving medications will be investigated with a table in which the research subjects enter drug names and sum up the number of tablets taken per day.
- Urine leakage will be examined by the research subjects checking either "Yes" or "no" on the question of whether they have had urine leakage on a daily basis.
- If this urine leakage has bothered the research subjects, it is investigated by ticking either "Yes" or "No" daily as a follow-up question to the previous one.
- The duration of hematuria will be examined by the research subjects checking either "Yes" or "No" on the question of whether they have had blood in the urine daily
- The change in LUTS measured by IPSS will be used to measure patient-perceived outcomes at baseline, after four, eight and twelve weeks, after six months and then annually for five years.
Data Analysis:
Descriptive statistics will be used to compile the PROMs data. Changes over time will be analyzed using repeated measures (ANOVA). Differences in outcome measures between the three different methods will be analyzed with the Mann-Whitney test for continuous, independent data pairs, and the Chi-Square test for categorical variables.
Ethical considerations:
The study will be conducted in accordance with the Declaration of Helsinki, and all participants will give their informed consent. Ethical approval will be sought from the Ethical Review Authority (EPM)
Significance and clinical relevance:
The results of this study will provide important insights into how patient-reported outcomes after benign prostate surgery can be used to improve surgical outcomes and patient counseling. The results will also be able to be used to compare outcome measures between the three different treatments used for BPH. By highlighting the patient's perspective, care can be developed to better meet the patients' needs and expectations, and by determining a "normal course" regarding these outcome measures, the results can also be used in the future to identify patients who deviate from the expected recovery course.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Transurethral resection of the prostate, Transurethral vaporization of the prostate, GreenLight laser enucleation of the prostate
- Medical subject headings
- Prostatic Hyperplasia
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
Thermocoagulation is used in contrast to the other methods
Transurethral vaporization of the prostateProcedure or surgery
Heat is used to vaporize prostate
GreenLight laser enucleation of the prostateProcedure or surgery
laser is used in contrast to the other methods
| Study group | Role | What they receive |
|---|---|---|
| Patient treated by transurethral surgical procedure | Patients treated for BPH with surgery Receives: Procedure: Transurethral resection of the prostate; Procedure: Transurethral vaporization of the prostate; Procedure: GreenLight laser enucleation of the prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postoperative pain levels
Day-by-day registration of pain by NRS (numeric response scale) for pain. Anchorpoints: 0 (no pain) to 10 (worst possible pain)
Measured: Day-by-day for three months
Secondary outcomes (5)
Use of analgesics postoperatively
Patients are to report all pain medication used day-by-day
Measured: Day-by-day for three months
Duration of postoperative hematuria
The patients register the incidence of hematuria day-by-day by checking either "yes" or "no"
Measured: Day-by-day for three months
Duration of postoperative leakage of urine
The patients record the incidence of leakage of urine day-by-day by checking either "yes" or "no" box
Measured: Day-by-day for three months
Concerns about urine leakage
If the patients have checked the box "yes" for urine leakage, they are asked to record if they are bothered by this leakage or not by checking either "yes" or "no" box
Measured: Day-by-day for three months
Changes in Lower Urinary Tract Symptoms as measured by the IPSS questionnaire
The patients are asked to complete the IPSS (International Prostatic Symptom Score) once a month. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Measured: Month-by-month for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start15 Mar 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (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.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region
- Responsible party
- Principal investigator, Joakim Stromberg, Sahlgrenska University Hospital
- Investigators
- Joakim BE Strömberg, MD, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852859
- Sponsor's protocol ID
- 2024-06211-01 EPM
- Status last verified
- May 2025
- First submitted
- 21 Feb 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-reported Pain and Symptom Relief During Three Months After Surgery for Benign Prostatic Hyperplasia.
- ClinicalTrials.gov ID
- NCT06852859
- Acronym / sponsor ID
- 2024-06211-01 EPM
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 28 Feb 2025 (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 is a prospective observational study in patients undergoing surgery for benign prostatic hyperplasia (BPH).
The purpose of the study is to investigate in great detail patients' recovery after surgery for BPH regarding pain, hematuria, urine leakage and use of pain-relieving medications for three months postoperatively. Patient-reported outcomes after three different surgical methods will be investigated: transurethral resection, transurethral vaporization and laser transurethral enucleation of the prostate (Green-LEP)
Research questions:
- How do patients rate their day-to-day pain during the first three months after surgery for BPH? How long does it take to be pain free?
- How does the patient estimate any day-to-day burning sensation during the first three months after surgery for BPH?
- How many painkilling tablets of a certain preparation and a certain strength take patients per day in the first three months after surgery for BPH?
- How long do patients have urinary leakage after surgery for BPH?
- Are the patients bothered by possible urine leakage and if so for how long after surgery for BPH?
- How long does one have macroscopic hematuria after surgery for BPH?
- How quickly are the patients' urinary tract problems affected according to the IPSS per month?
- Are the results on the above outcome measures different between the three TUR-P methods, TUV-P and Green LEP?
Detailed description
Design and selection:
This is a prospective multicenter observational study in which patients undergoing TUR-P, TUV-P and GreenLEP for BPH are included. The subjects will be followed up with a self-assessment form that is completed daily for three months and then sent to the responsible researchers. After this, the research subjects will be followed up with sent out IPSS forms after six months, and then annually for up to five years. These are sent in stamped envelopes.
Participants:
The study will include 500 patients who undergo surgery for BPH at Alingsås hospital, Sjukhusen i Väster and Sahlgrenska University Hospital, as well as possibly an additional urology clinic in the future. The inclusion criteria include men over 50 years of age with diagnosed BPH and LUTS who have an indication for surgery with any of the three methods studied.
Outcome measures:
- Pain and burning will be assessed using the NRS (numeric scale) between 0 and 10 where 0 is defined as "no pain/burning" and 10 is defined as "worst imaginable pain/burning". The researchers fill in this day-by-day for three months
- Use of pain-relieving medications will be investigated with a table in which the research subjects enter drug names and sum up the number of tablets taken per day.
- Urine leakage will be examined by the research subjects checking either "Yes" or "no" on the question of whether they have had urine leakage on a daily basis.
- If this urine leakage has bothered the research subjects, it is investigated by ticking either "Yes" or "No" daily as a follow-up question to the previous one.
- The duration of hematuria will be examined by the research subjects checking either "Yes" or "No" on the question of whether they have had blood in the urine daily
- The change in LUTS measured by IPSS will be used to measure patient-perceived outcomes at baseline, after four, eight and twelve weeks, after six months and then annually for five years.
Data Analysis:
Descriptive statistics will be used to compile the PROMs data. Changes over time will be analyzed using repeated measures (ANOVA). Differences in outcome measures between the three different methods will be analyzed with the Mann-Whitney test for continuous, independent data pairs, and the Chi-Square test for categorical variables.
Ethical considerations:
The study will be conducted in accordance with the Declaration of Helsinki, and all participants will give their informed consent. Ethical approval will be sought from the Ethical Review Authority (EPM)
Significance and clinical relevance:
The results of this study will provide important insights into how patient-reported outcomes after benign prostate surgery can be used to improve surgical outcomes and patient counseling. The results will also be able to be used to compare outcome measures between the three different treatments used for BPH. By highlighting the patient's perspective, care can be developed to better meet the patients' needs and expectations, and by determining a "normal course" regarding these outcome measures, the results can also be used in the future to identify patients who deviate from the expected recovery course.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient treated by transurethral surgical procedure | – | Procedure: Transurethral resection of the prostate, Procedure: Transurethral vaporization of the prostate, Procedure: GreenLight laser enucleation of the prostatePatients treated for BPH with surgery |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for surgery for benign prostatic hyperplasia
Key inclusion criteria (2 listed)
- Patients undergoing transurethral surgery for benign prostatic hyperplasia
- Singed informed consent to participate
Key exclusion criteria (1 listed)
- Non-swedish speaking patients
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 prostateThermocoagulation is used in contrast to the other methods | Procedure or surgery | Patient treated by transurethral surgical procedure |
| Transurethral vaporization of the prostateHeat is used to vaporize prostate | Procedure or surgery | Patient treated by transurethral surgical procedure |
| GreenLight laser enucleation of the prostatelaser is used in contrast to the other methods | Procedure or surgery | Patient treated by transurethral surgical procedure |
Primary outcome
Change in postoperative pain levels
Time frame: Day-by-day for three months
Day-by-day registration of pain by NRS (numeric response scale) for pain. Anchorpoints: 0 (no pain) to 10 (worst possible pain)
5 secondary outcomes
Use of analgesics postoperatively
Time frame: Day-by-day for three months
Duration of postoperative hematuria
Time frame: Day-by-day for three months
Duration of postoperative leakage of urine
Time frame: Day-by-day for three months
Concerns about urine leakage
Time frame: Day-by-day for three months
Changes in Lower Urinary Tract Symptoms as measured by the IPSS questionnaire
Time frame: Month-by-month for 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Joakim BE Strömberg, MD, PhD principal investigator
Sahlgrenska University Hospital
3 sites 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 Sahlgrenska University Hospital at 3 sites 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 2 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: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joakim BE Strömberg, MD, PhD (46-768-341-327, joakim.stromberg@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in postoperative pain levels (time frame: Day-by-day for three 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 16 May 2025.