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

Not Applicable

Recruiting

• Conditions: Prostate Hyperplasia
• Interventions: Drug: Tamsulosin Hydrochloride; Other: Sham

• Registration Number: NCT06865430
• Lead Sponsor: Ankara Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-04
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-04
• Study First Posted: 2025-03-07
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-24
• Primary Completion: 2025-09-04
• Study Completion: 2026-03-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GROUP USING ALPHA BLOCKERS	Tamsulosin Hydrochloride	Alpha blockers will be started and irritative symptoms will be questioned.
GROUP NOT USING ALPHA BLOCKERS	Sham	Patients who were not started on alpha blockers will constitute this group.

Primary Outcome Measures

Name	Time	Method
dysuria vas score out of 10 points	ONE MONTH
urgency vas score out of 10 points	ONE MONTH
ıpps score	ONE MONTH

Trial Locations

Locations (1)

Ankara bilkent city hospital; 🇹🇷 Ankara, Turkey