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

NCT06865430 | Recruiting

• 1 other identifier: AŞH.AKYILDIZ.008
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Hyperplasia

Outcome Measures

Primary Outcomes (3)

• dysuria vas score out of 10 points

  ONE MONTH

• urgency vas score out of 10 points

  ONE MONTH

• ıpps score

  ONE MONTH

Study Arms (2)

GROUP USING ALPHA BLOCKERS

ACTIVE COMPARATOR

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

Drug: Tamsulosin Hydrochloride

GROUP NOT USING ALPHA BLOCKERS

PLACEBO COMPARATOR

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

Other: Sham

Interventions

Tamsulosin Hydrochloride DRUG

Alpha blockers will be started and symptoms will be questioned.

GROUP USING ALPHA BLOCKERS

Sham OTHER

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

GROUP NOT USING ALPHA BLOCKERS

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Training and Research Hospital: lead

Study Sites (1)

Ankara bilkent city hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tamsulosin; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Central Study Contacts

Kazım Ceviz

CONTACT

312 552 66 00; kazimmzz@hotmail.com

Ankara Bilkent City Hospital Oncology

CONTACT

312 552 66 00

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 7, 2025
• Study Start: March 4, 2025
• Primary Completion: September 4, 2025
• Study Completion: March 4, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)