An interventional study of Tamsulosin Hydrochloride and Sham in Prostate Hyperplasia, sponsored by Ankara Training and Research Hospital. Recruiting at 1 site in Turkey. Open to male participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-03-24.
Sponsored by Ankara Training and Research Hospital · Not applicable, Interventional, and Prevention
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.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 82 is below the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Ankara Training and Research Hospital is the lead sponsor of 48 studies on the registry; 8 are open to participants now.
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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
Alpha blockers will be started and irritative symptoms will be questioned.
Drug: Tamsulosin Hydrochloride
Patients who were not started on alpha blockers will constitute this group.
Other: Sham
Alpha blockers will be started and symptoms will be questioned.
Patients who were not started on alpha blockers will constitute this group.
dysuria vas score out of 10 points
Time frame: ONE MONTH
urgency vas score out of 10 points
Time frame: ONE MONTH
ıpps score
Time frame: ONE MONTH
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Sep 2025, 6 months after the start.
Of 152 non-industry interventional studies with no phase under Prostatic Hyperplasia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 6 months is below that.
Counting every sponsor, half of 203 studies reached it within 26 months; a quarter within 14 and three quarters within 48.
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Studies of the drug tested here: Tamsulosin
Ankara Training and Research Hospital