EEAP Using Moses 2.0 Technology vs the Thulium Fiber Laser in Medium-Large Prostates
- Conditions
- Prostatic HyperplasiaSurgeryEndoscopic Anatomical Enucleation of the Prostate (EEAP)
- Registration Number
- NCT06565741
- Lead Sponsor
- Fundacio Puigvert
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Males aged between 40 and 90 years.<br><br> - Patients who, due to their lower urinary tract symptoms, are candidates for<br><br>BPH surgery, including:<br><br> - Obstructive urinary symptoms evaluated through IPSS with a score >7 and QoL ><br> 2 or acute urinary reten on refractory to catheter removal.<br><br> - Obstructive urinary flow evaluated through uroflowmetry with Qmax< 15 ml/s,<br> obstruction demonstrated by pressure/flow study, prostatic origin haematuria<br> refractory to medical treatment, or acute urinary retention refractory to catheter<br> removal.<br><br> - Prostatic volume measured by transabdominal ultrasound, transrectal ultrasound,<br> or magnetic resonance imaging of more than 80 cc.<br><br> - Prostate-specific antigen (PSA) < 4 ng/ml, or with multiparametric prostate<br> magnetic resonance imaging reporting PIRADS < 3 or equal to 3 with PSA<br> density < 15%.<br><br>Exclusion Criteria:<br><br> - Diagnosis, suspicion, or history of urethral stenosis or urethral surgery.<br><br> - History of prostate surgery or pelvic radiotherapy.<br><br> - Diagnosis or suspicion of prostate cancer or urothelial cancer.<br><br> - Body mass index superior to 30.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SURGICAL TIME
- Secondary Outcome Measures
Name Time Method Perioperative bleeding;Postoperative hospital stay;Perioperative complications;Urinary symptoms;Flowmetric variables maximum flow;Flowmetric variables average flow;Flowmetric variables post-void residual