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| Name | Class |
|---|---|
| Vastra Gotaland Region | OTHER_GOV |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient treated by transurethral surgical procedure | Patients treated for BPH with surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transurethral resection of the prostate | Procedure | Thermocoagulation is used in contrast to the other methods |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day-by-day for three months |
| Measure | Description | Time Frame |
|---|---|---|
| Use of analgesics postoperatively | Patients are to report all pain medication used day-by-day | 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" |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled for surgery for benign prostatic hyperplasia
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joakim BE Strömberg, MD, PhD | Contact | 46-768-341-327 | joakim.stromberg@vgregion.se |
| Name | Affiliation | Role |
|---|---|---|
| Joakim BE Strömberg, MD, PhD | Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alingsås lasarett, department of general surgery, urology and orthopaedic surgery | Recruiting | Alingsås | Sweden | |||
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| Transurethral vaporization of the prostate | Procedure | Heat is used to vaporize prostate |
|
| GreenLight laser enucleation of the prostate | Procedure | laser is used in contrast to the other methods |
|
| 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 | 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 | 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. | Month-by-month for 3 months |
| Kungälvs sjukhus, department of urology |
| Not yet recruiting |
| Kungälv |
| Sweden |
| NU sjukvården, Uddevalla sjukhus, department of urology | Not yet recruiting | Uddevalla | Sweden |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D020728 | Transurethral Resection of Prostate |
| ID | Term |
|---|---|
| D011468 | Prostatectomy |
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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