Comparative evaluation of the surgical outcome Thulium laser enucleation of the prostate

Not Applicable

Completed

• Conditions: Cancer; Benign prostatic hyperplasia, benign bladder outlet obstruction, urology

• Registration Number: ISRCTN72879639
• Lead Sponsor: niversity Hospital of Patras

Brief Summary

2021 results in https://pubmed.ncbi.nlm.nih.gov/33622326/ (added 26/02/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-25
• Study Completion: 2016-12-31
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 90

Inclusion Criteria

Candidates for surgical treatment of Benign Prostatoc Hyperplasia (BPH):
1. Prostate volume >60ml
2. Qmax <15ml/s
3. Post-void residual (PVR) <150ml
4. Insufficient conservative or pharmacological treatment of BPH
5. Urodynamic confirmation of bladder outlet obstruction

Exclusion Criteria

1. Prostate volume <60ml
2. Qmax >15ml/s
3. Post-void residual (PVR) >150ml

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Symptoms (International Prostate Symptom Score, I-PSS), measured pre-operatively, at 1 month, at 3 months and at 12 months<br> 2. Maximum flow rate: Urodynamic evaluation, measured pre-operatively and at 3 months<br> 3. Time for catheter removal<br> 4. Erectile function (International Index of Erectile Function Questionnaire, IIEF) at 1 month, 3 months and 12 months<br> 5. Complications during first month after surgery and at 12 months<br>

Secondary Outcome Measures

Name	Time	Method
Treatment cost