Comparing two laser techniques for prostate surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of two laser techniques, MoLEP and ThuFLEP, for endoscopic anatomical enucleation of the prostate in men with medium to large prostates. The study will evaluate the enucleation efficiency and perioperative bleeding associated with each technique. A total of 120 male patients aged 40 to 90 years, who are candidates for surgery due to lower urinary tract symptoms, will be randomly assigned to one of the two treatment groups. Follow-up assessments will occur at various intervals post-surgery to monitor outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Males aged between 40 and 90 years.
* Patients who, due to their lower urinary tract symptoms, are candidates for

BPH surgery, including:

* Obstructive urinary symptoms evaluated through IPSS with a score \>7 and QoL \> 2 or acute urinary reten on refractory to catheter removal.
* Obstructive urinary flow evaluated through uroflowmetry with Qmax\< 15 ml/s, obstruction demonstrated by pressure/flow study, prostatic origin haematuria refractory to medical treatment, or acute urinary retention refractory to catheter removal.

  * Prostatic volume measured by transabdominal ultrasound, transrectal ultrasound, or magnetic resonance imaging of more than 80 cc.
  * Prostate-specific antigen (PSA) \< 4 ng/ml, or with multiparametric prostate magnetic resonance imaging reporting PIRADS \< 3 or equal to 3 with PSA density \< 15%.

Exclusion Criteria:

* Diagnosis, suspicion, or history of urethral stenosis or urethral surgery.
* History of prostate surgery or pelvic radiotherapy.
* Diagnosis or suspicion of prostate cancer or urothelial cancer.
* Body mass index superior to 30.

Where it's running

• Fundacio Puigvert
  Barcelona, Barcelona, Spain Recruiting
• Clinic Hospital of Barcelona
  Barcelona, Barcelona, Spain Recruiting
• Hospital Univesitari de Bellvitge
  L'Hospitalet de Llobregat, Barcelona, Spain Recruiting

Study contacts

• Principal investigator: Ivan Schwartzmann Jochamowitz, MD — Fundacio Puigvert
• Study coordinator: Ivan Schwartzmann Jochamowitz, MD
• Email: ischwartzm@fundacio-puigvert.es
• Phone: 0034934169700

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.