Clinical trial NCT06865430: Management of Dysuria and Irritative Symptoms After HoLEP: a Prospective Study Evaluating the Efficacy of Alpha-Blocker Therapy
Official title: Management of Dysuria and Irritative Symptoms After HoLEP: a Prospective Study Evaluating the Efficacy of Alpha-Blocker Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Hyperplasia
Lead sponsor: Ankara Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 82
Sex: MALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: dysuria vas score out of 10 points
timeFrame: ONE MONTH
measure: urgency vas score out of 10 points
timeFrame: ONE MONTH
measure: ıpps score
timeFrame: ONE MONTH
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara bilkent city hospital
Study officials:
References: