NCT06852859

Brief 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?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Mar 2025

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress61%
Mar 2025Jan 2027

First Submitted

Initial submission to the registry

February 21, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

March 15, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

1.9 years

First QC Date

February 21, 2025

Last Update Submit

May 15, 2025

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Use of analgesics postoperatively

    Day-by-day for three months

  • Duration of postoperative hematuria

    Day-by-day for three months

  • Duration of postoperative leakage of urine

    Day-by-day for three months

  • Concerns about urine leakage

    Day-by-day for three months

  • Changes in Lower Urinary Tract Symptoms as measured by the IPSS questionnaire

    Month-by-month for 3 months

Study Arms (1)

Patient treated by transurethral surgical procedure

Patients treated for BPH with surgery

Procedure: Transurethral resection of the prostateProcedure: Transurethral vaporization of the prostateProcedure: GreenLight laser enucleation of the prostate

Interventions

Transurethral resection of the prostatePROCEDURE

Thermocoagulation is used in contrast to the other methods

Patient treated by transurethral surgical procedure
Transurethral vaporization of the prostatePROCEDURE

Heat is used to vaporize prostate

Patient treated by transurethral surgical procedure
GreenLight laser enucleation of the prostatePROCEDURE

laser is used in contrast to the other methods

Patient treated by transurethral surgical procedure

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for surgery for benign prostatic hyperplasia

You may qualify if:

  • Patients undergoing transurethral surgery for benign prostatic hyperplasia
  • Singed informed consent to participate

You may not qualify if:

  • Non-swedish speaking patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Joakim BE Strömberg, MD, PhD

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joakim BE Strömberg, MD, PhD

CONTACT

46-768-341-327joakim.stromberg@vgregion.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 21, 2025

First Posted

February 28, 2025

Study Start

March 15, 2025

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

May 16, 2025

Record last verified: 2025-05

Locations

SE(3)