Clinical trial NCT05130918: Efficacy of Mictalase® After ThuLEP
Official title: The Efficacy of a Suppository Based on Phenolmicin P3 and Bosexil in Control of Irritative Symptoms in Patients Undergoing Thulium Laser Enucleation of Prostate: a Single-center, Randomized, Controlled, Open Label, Phase III Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
Keywords: benign prostatic hyperplasia
BPH
laser enucleation
ThuLEP
LUTS
urinary tract infections
Lead sponsor: San Carlo di Nancy Hospital
Sponsor class: OTHER
Collaborators: name: Lampugnani Farmaceutici S.p.A. (Nerviano, Milan, Italy)
First posted: 2021-11-23
Enrollment: 111
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: IPSS
timeFrame: 15 and 30 days post-operation
measure: QoL
timeFrame: 15 and 30 days post-operation
Secondary outcomes:
measure: Urinary Infection
timeFrame: 15 and 30 days post-operation
Other outcomes:
Locations:
city: Roma
country: Italy
facility: San Carlo di Nancy Hospital
Study officials:
affiliation: San Carlo di Nancy Hospital
name: Pierluigi Bove, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bertolo R, Cipriani C, Vittori M, Carilli M, Maiorino F, Iacovelli V, Ganini C, Antonucci M, Signoretti M, Petta F, Panei M, Bove P. The efficacy of a suppository based on Phenolmicin P3 and Bosexil (Mictalase(R)) in control of irritative symptoms in patients undergoing thulium laser enucleation of prostate: a single-center, randomized, controlled, open label, phase III study. BMC Urol. 2022 Feb 12;22(1):19. doi: 10.1186/s12894-022-00974-0.