Skip to main content
Clinical Trials/NCT06865430
NCT06865430RecruitingNot Applicable

Management of Dysuria and Irritative Symptoms After HoLEP: a Prospective Study Evaluating the Efficacy of Alpha-Blocker Therapy

Ankara Training and Research Hospital1 site in 1 country82 target enrollmentStarted: March 4, 2025Last updated:
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
82
Locations
1
Primary Endpoint
dysuria vas score out of 10 points

Study Overview

Brief Summary

Holmium Laser Enucleation of the Prostate (HoLEP) is an increasingly popular endoscopic minimally invasive surgical technique for the treatment of benign prostatic hyperplasia (BPH). In the literature, the long-term efficacy and low complication rates of HoLEP have been highlighted in many studies. However, in the early postoperative period, particularly within the first three months, irritative symptoms are reported in 17-35% of cases (1-2).

The pathophysiology of postoperative irritative symptoms is not yet fully understood, but it has been suggested that these symptoms may be associated with urethral trauma, the mucosal healing process, and detrusor overactivity. These symptoms can significantly impact quality of life, reducing patient satisfaction. In particular, dysuria is a frequently encountered symptom after HoLEP, with considerable individual variability in its severity and duration.

The effectiveness of alpha-blockers in alleviating postoperative dysuria and irritative symptoms remains a topic of debate in the literature. Although prostate tissue is surgically removed, alpha-blockers may improve urinary flow and relieve symptoms associated with bladder outlet obstruction by reducing urethral smooth muscle tone (3). Studies on the use of alpha-blockers following transurethral resection of the prostate (TURP) have shown limited postoperative benefits (4). However, to the best of our knowledge, no study has specifically evaluated their use following HoLEP, an enucleation-based technique. Therefore, further studies are needed to assess the role of alpha-blockers in managing dysuria after HoLEP.

The aim of this study is to evaluate the effectiveness of alpha-blocker therapy in managing dysuria and other irritative symptoms following HoLEP. Additionally, the study seeks to determine the impact of this treatment on quality of life and patient satisfaction.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
40 Years to 85 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Men over 40 years old, under 85 years old, and HoLEP surgery

Exclusion Criteria

  • Prostate cancer, patients with bladder stones, patients with a history of urethral stricture, patients with detrusor underactivity in urodynamics, those who have had prostate surgery before

Arms & Interventions

GROUP USING ALPHA BLOCKERS

Active Comparator

Alpha blockers will be started and irritative symptoms will be questioned.

Intervention: Tamsulosin Hydrochloride (Drug)

GROUP NOT USING ALPHA BLOCKERS

Placebo Comparator

Patients who were not started on alpha blockers will constitute this group.

Intervention: Sham (Other)

Outcomes

Primary Outcomes

dysuria vas score out of 10 points

Time Frame: ONE MONTH

urgency vas score out of 10 points

Time Frame: ONE MONTH

ıpps score

Time Frame: ONE MONTH

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Ankara Training and Research Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ali Kaan Yildiz

principle investigator

Ankara Training and Research Hospital

Study Sites (1)

Loading locations...

Similar Trials