Efficacy of Mictalase® After ThuLEP

San Carlo di Nancy Hospital

Status: Completed

Conditions: BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms

Treatments: Device: Phenolmicin P3 and Bosexil suppository

Study type: Interventional

Funder types: Other

Identifiers

NCT05130918

Mictalase

Details and patient eligibility

About

In this single-center, prospective, randomized, open label, phase-III study, patients with indication to Thulium Laser Enucleation of Prostate were enrolled. The report conformed to CONSORT 2010 guidelines. Eligible patients were 1:1 randomized. Randomization defined Group A: patients who were administered Phenolmicin P3 and Bosexil suppositories twice a day for 5 days, then once a day for other 10 days; Group B: patients who did not receive the suppositories ("controls"). Study endpoints were evaluated at 15 and 30 days postoperation. Primary endpoint included evaluation of effects of the suppository on irritative symptoms by administering International Prostate Symptom Score (IPSS) with Quality of Life (QoL) questionnaire. Secondary endpoint included evaluation of effects on urinary tract infections by performance of urinalysis with urine culture.

Enrollment: 111 patients

Sex: Male

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with symptomatic benign prostatic hyperplasia deemed eligible for thulium laser enucleation of prostate.

Exclusion criteria

• patients with history of prostatitis,
• patients with history of neurogenic detrusor overactivity (as determined after urodynamic observation),
• patients diagnosed with prostate cancer,
• patients who underwent previous surgeries of the lower urinary tract,
• patients with indwelling catheter,
• patients with history of nephrolithiasis,
• patients with known or suspected hypersensitivity to Phenolmicin P3 and/or Bosexil
• patients experiencing occurrence of severe intraoperative complications.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 2 patient groups

Phenolmicin P3 and Bosexil

Experimental group

Description:

Group in which patients were administered Phenolmicin P3 and Bosexil suppositories twice a day for 5 days, then once a day for other 10 days after thulium laser enucleation of prostate was performed.

Treatment:

Device: Phenolmicin P3 and Bosexil suppository

Controls

No Intervention group

Description:

Group in which patients were not administered Phenolmicin P3 and Bosexil suppositories after thulium laser enucleation of prostate was performed.