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Comparison study of the different Surgical Techniques for the treatment of Benign prostatic growth with large volume: Endoscopic Laser Treatment x Minimally-invasive Abdominal Treatment x Endoscopic Treatment with Bipolar Energy

Randomized clinical trial evaluating the Surgical Treatment of large-volume Benign Prostatic Hyperplasia: Endoscopic Enucleation with Holmium Laser x Minimally-invasive Simple Prostatectomy x Bipolar Transurethral Resection of Prostate

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-427g9ht
Enrollment
Unknown
Registered
2023-10-27
Start date
2023-10-30
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hypertrophy

Interventions

This is a three-arm randomized controlled clinical trial. A total of 240 people who meet the eligibility criteria will be probabilistically allocated to one of the groups of intervention using a table
E04.950.774.860.625
E04.950.774.860.625.750

Sponsors

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Lead Sponsor
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Collaborator

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Prostatic volume between 80 and 150mL measured by abdominal ultrasound of the prostate. Present at least one indication criteria for surgical treatment of Benign prostatic hyperplasia (BPH): renal failure with bilateral ureterohydronephrosis, recurrent macroscopic hematúria, acute urinary retention, recurrent urinary tract infection secondary to high post-void volume, moderate to severe voiding urinary symptoms even with clinical treatment interpreted by International Prostate Symptom Score (IPSS) > 15 and/or maximum urinary flow (Qmax) 15 and/or maximum urinary flow (Qmax) < 12mL/s in patients intolerant to pharmacological therapy

Exclusion criteria

Exclusion criteria: Prostate câncer. Neurogenic bladder. Previous prostatic surgeries. Bladder stones. Urethral pathologies. Impossibility of suspending anticoagulants or anti-platelet agentes

Design outcomes

Primary

MeasureTime frame
To evaluate the difference in the quality of postoperative recovery of patients undergoing different surgical techniques for the treatment of large-volume benign prostatic hyperplasia, using the quality of recovery score (QoR-VAR), based on the observation of a variation statistically significant (p = 0.05) of pre- and post-intervention measurements.;To evaluate the different surgical techniques used to treat large-volume benign prostatic hyperplasia in terms of surgical and functional results, through complementary exams and questionnaires applied in the postoperative follow-up, based on the finding of a statistically significant variation (p = 0, 05) of pre- and post-intervention measurements.—

Secondary

MeasureTime frame
No secondary outcomes are expected—

Countries

Brazil

Contacts

Public ContactFelipe Pugliesi

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

urofelipepugliesi@gmail.com+55(11)2661-6239

Outcome results

None listed

Source: REBEC (via WHO ICTRP)