Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-03 @ 6:03 AM
Study NCT ID:
NCT06852859
Status:
RECRUITING
Last Update Posted:
2025-05-16
First Post:
2025-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient-reported Pain and Symptom Relief During Three Months After Surgery for Benign Prostatic Hyperplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020728', 'term': 'Transurethral Resection of Prostate'}], 'ancestors': [{'id': 'D011468', 'term': 'Prostatectomy'}, {'id': 'D013521', 'term': 'Urologic Surgical Procedures, Male'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2025-02-21', 'studyFirstSubmitQcDate': '2025-02-27', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in postoperative pain levels', 'timeFrame': 'Day-by-day for three months', 'description': 'Day-by-day registration of pain by NRS (numeric response scale) for pain. Anchorpoints: 0 (no pain) to 10 (worst possible pain)'}], 'secondaryOutcomes': [{'measure': 'Use of analgesics postoperatively', 'timeFrame': 'Day-by-day for three months', 'description': 'Patients are to report all pain medication used day-by-day'}, {'measure': 'Duration of postoperative hematuria', 'timeFrame': 'Day-by-day for three months', 'description': 'The patients register the incidence of hematuria day-by-day by checking either "yes" or "no"'}, {'measure': 'Duration of postoperative leakage of urine', 'timeFrame': 'Day-by-day for three months', 'description': 'The patients record the incidence of leakage of urine day-by-day by checking either "yes" or "no" box'}, {'measure': 'Concerns about urine leakage', 'timeFrame': 'Day-by-day for three months', 'description': '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'}, {'measure': 'Changes in Lower Urinary Tract Symptoms as measured by the IPSS questionnaire', 'timeFrame': 'Month-by-month for 3 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': "This is a prospective observational study in patients undergoing surgery for benign prostatic hyperplasia (BPH).\n\nThe 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)\n\nResearch questions:\n\n* 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?\n* How does the patient estimate any day-to-day burning sensation during the first three months after surgery for BPH?\n* 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?\n* How long do patients have urinary leakage after surgery for BPH?\n* Are the patients bothered by possible urine leakage and if so for how long after surgery for BPH?\n* How long does one have macroscopic hematuria after surgery for BPH?\n* How quickly are the patients' urinary tract problems affected according to the IPSS per month?\n* Are the results on the above outcome measures different between the three TUR-P methods, TUV-P and Green LEP?", 'detailedDescription': 'Design and selection:\n\nThis 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.\n\nParticipants:\n\nThe 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.\n\nOutcome measures:\n\n1. 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\n2. 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.\n3. 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.\n4. 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.\n5. 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\n6. 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.\n\nData Analysis:\n\nDescriptive 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.\n\nEthical considerations:\n\nThe 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)\n\nSignificance and clinical relevance:\n\nThe 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for surgery for benign prostatic hyperplasia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing transurethral surgery for benign prostatic hyperplasia\n* Singed informed consent to participate\n\nExclusion Criteria:\n\n* Non-swedish speaking patients'}, 'identificationModule': {'nctId': 'NCT06852859', 'briefTitle': 'Patient-reported Pain and Symptom Relief During Three Months After Surgery for Benign Prostatic Hyperplasia', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'Patient-reported Pain and Symptom Relief During Three Months After Surgery for Benign Prostatic Hyperplasia.', 'orgStudyIdInfo': {'id': '2024-06211-01 EPM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient treated by transurethral surgical procedure', 'description': 'Patients treated for BPH with surgery', 'interventionNames': ['Procedure: Transurethral resection of the prostate', 'Procedure: Transurethral vaporization of the prostate', 'Procedure: GreenLight laser enucleation of the prostate']}], 'interventions': [{'name': 'Transurethral resection of the prostate', 'type': 'PROCEDURE', 'description': 'Thermocoagulation is used in contrast to the other methods', 'armGroupLabels': ['Patient treated by transurethral surgical procedure']}, {'name': 'Transurethral vaporization of the prostate', 'type': 'PROCEDURE', 'description': 'Heat is used to vaporize prostate', 'armGroupLabels': ['Patient treated by transurethral surgical procedure']}, {'name': 'GreenLight laser enucleation of the prostate', 'type': 'PROCEDURE', 'description': 'laser is used in contrast to the other methods', 'armGroupLabels': ['Patient treated by transurethral surgical procedure']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alingsås', 'status': 'RECRUITING', 'country': 'Sweden', 'facility': 'Alingsås lasarett, department of general surgery, urology and orthopaedic surgery', 'geoPoint': {'lat': 57.93033, 'lon': 12.53345}}, {'city': 'Kungälv', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'facility': 'Kungälvs sjukhus, department of urology', 'geoPoint': {'lat': 57.87096, 'lon': 11.98054}}, {'city': 'Uddevalla', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'facility': 'NU sjukvården, Uddevalla sjukhus, department of urology', 'geoPoint': {'lat': 58.34784, 'lon': 11.9424}}], 'centralContacts': [{'name': 'Joakim BE Strömberg, MD, PhD', 'role': 'CONTACT', 'email': 'joakim.stromberg@vgregion.se', 'phone': '46-768-341-327'}], 'overallOfficials': [{'name': 'Joakim BE Strömberg, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vastra Gotaland Region', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Joakim Stromberg', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}