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Clinical Trials in Sweden / NCT06852859
Recruiting Observational

Patient-reported Pain and Symptom Relief During Three Months After Surgery for Benign Prostatic Hyperplasia

NCT06852859 · tracked via the Priya Life Science Sweden tracker
Sponsor
Sahlgrenska University Hospital
Phase
Observational
Started
2025-03-15
Last updated
2025-05-16

Condition(s) studied

Benign Prostatic Hyperplasia

Investigational drug(s) / intervention(s)

Transurethral resection of the prostateTransurethral vaporization of the prostateGreenLight laser enucleation of the prostate

Transurethral resection of the prostate: Thermocoagulation is used in contrast to the other methods

Transurethral vaporization of the prostate: Heat is used to vaporize prostate

GreenLight laser enucleation of the prostate: laser is used in contrast to the other methods

Study 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 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?

Eligibility

Sex
MALE
Min age
50 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients undergoing transurethral surgery for benign prostatic hyperplasia * Singed informed consent to participate Exclusion Criteria: * Non-swedish speaking patients

Primary outcome measure(s)

  • Change in postoperative pain levels — 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)

Trial sites (3)

FacilityCityRegionStatus
Alingsås lasarett, department of general surgery, urology and orthopaedic surgery Alingsås Sweden Recruiting
Kungälvs sjukhus, department of urology Kungälv Sweden Not Yet Recruiting
NU sjukvården, Uddevalla sjukhus, department of urology Uddevalla Sweden Not Yet Recruiting

More Sahlgrenska University Hospital trials in Sweden

Venous Resection in Patients Undergoing Pancreatic Surgery Starting soon
Preventive Physical Activity Intervention in Head and Neck Cancer Recruiting
VALidation of Imaging-based Liver Biomarkers in PEDiatric Patients Recruiting
CBT Treatment for Internet Gaming Disorder Starting soon
Reperfusion Treatment in Acute Pulmonary Embolism Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06852859 on ClinicalTrials.gov ↗ ← All trials in Sweden