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NCT06865430
Management of Dysuria and Irritative Symptoms After HoLEP: a Prospective Study Evaluating the Efficacy of Alpha-Blocker Therapy
NA trial testing Tamsulosin Hydrochloride in Prostate Hyperplasia in 82 participants. Currently enrolling.
4 September 2025
Quick facts
| Lead sponsor | Ankara Training and Research Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 82 |
| Start date | 4 March 2025 |
| Primary completion | 4 September 2025 |
| Estimated completion | 4 March 2026 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Tamsulosin Hydrochloride — full drug profile →
- Sham
Conditions studied
- Prostate Hyperplasia — all drugs for Prostate Hyperplasia →
Sponsor
Ankara Training and Research Hospital
Who can join
Adults 40 to 85, male only, with Prostate Hyperplasia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Other Ankara Training and Research Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06865430 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ankara Training and Research Hospital
- Last refreshed: 24 March 2025
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