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

Ankara Training and Research Hospital

Status: Enrolling

Conditions: Prostate Hyperplasia

Treatments: Other: Sham; Drug: Tamsulosin Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT06865430

AŞH.AKYILDIZ.008

Details and patient eligibility

About

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.

Enrollment: 82 estimated patients

Sex: Male

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

82 participants in 2 patient groups, including a placebo group

GROUP USING ALPHA BLOCKERS

Active Comparator group

Description:

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

Treatment:

Drug: Tamsulosin Hydrochloride

GROUP NOT USING ALPHA BLOCKERS

Placebo Comparator group

Description:

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

Treatment:

Other: Sham