BPH With Urinary Obstruction With Other Lower Urinary Tract SymptomsNCT05130918
Efficacy of Mictalase® After ThuLEP
A study testing Phenolmicin P3 and Bosexil suppository in people with BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms, run by San Carlo di Nancy Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
- What is being tested?
- Phenolmicin P3 and Bosexil suppository
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2019to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptomatic benign prostatic hyperplasia deemed eligible for thulium laser enucleation of prostate.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Phenolmicin P3 and Bosexil suppository
- Keywords
- benign prostatic hyperplasia, BPH, laser enucleation, ThuLEP, LUTS, urinary tract infections
- Medical subject headings
- Prostatic Hyperplasia, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenolmicin P3 and Bosexil suppositoryDevice
Also called Mictalase
The suppository we herein investigated includes different active principles, namely: Bosexil®, that is a vegetal extract derived from the resin of the Boswellia serrata, a plant native to India. It has already been published that the Boswellic acids contained show anti-inflammatory and antioxidant properties in a variety of inflammatory diseases whose physio-pathological pathways are shared with those of prostatitis; phenolmicin P3 is a polyphenolic extract derived from beehive propolis, that also demonstrated anti-inflammatory and antioxidant properties in preclinical reports. It has also been reported to have the ability to create a microenvironment hostile to the reproduction of pathogenic bacteria.
| Study group | Role | What they receive |
|---|---|---|
| Phenolmicin P3 and Bosexil | Experimental | 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. Receives: Device: Phenolmicin P3 and Bosexil suppository |
| Controls | No intervention | Group in which patients were not administered Phenolmicin P3 and Bosexil suppositories after thulium laser enucleation of prostate was performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPSS
evaluation of effects of the suppository on irritative symptoms as assessed by eventual reduction in International Prostate Symptom Score (IPSS).
Specifically, % reduction in absolute value of IPSS will be compared between the groups.
Measured: 15 and 30 days post-operation
QoL
evaluation of effects of the suppository on Quality of life as assessed by eventual reduction in Quality of Life score.
Specifically, % reduction in absolute value of QoL will be compared between the groups.
Measured: 15 and 30 days post-operation
Secondary outcomes (1)
Urinary Infection
evaluation of effects of the suppository on occurrence of urinary infections after thulium laser enucleation of prostate as assessed by urine culture.
Specifically, the rates of positive urine culture will be compared between the groups.
Measured: 15 and 30 days post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start1 Dec 2019
- Primary completion28 Feb 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BPH With Urinary Obstruction With Other Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Carlo di Nancy Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lampugnani Farmaceutici S.p.A. (Nerviano, Milan, Italy)
- Responsible party
- Sponsor
- Investigators
- Pierluigi Bove, MD, Principal investigator, San Carlo di Nancy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130918
- Sponsor's protocol ID
- Mictalase
- Status last verified
- Nov 2021
- First submitted
- 2 Nov 2021
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The analysis of the data obtained within the trial will be subject of scientific publication
Publications
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.
PubMed 35151280
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05130918
- Acronym / sponsor ID
- Mictalase
- Keywords
- benign prostatic hyperplasia, BPH, laser enucleation, ThuLEP, LUTS, urinary tract infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- San Carlo di Nancy HospitalUniversity, hospital or other
- Collaborators
- Lampugnani Farmaceutici S.p.A. (Nerviano, Milan, Italy)
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenolmicin P3 and Bosexil | Experimental | Device: Phenolmicin P3 and Bosexil suppositoryGroup 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. |
| Controls | No intervention | –Group in which patients were not administered Phenolmicin P3 and Bosexil suppositories after thulium laser enucleation of prostate was performed. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with symptomatic benign prostatic hyperplasia deemed eligible for thulium laser enucleation of prostate.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phenolmicin P3 and Bosexil suppositoryAlso: MictalaseThe suppository we herein investigated includes different active principles, namely: Bosexil®, that is a vegetal extract derived from the resin of the Boswellia serrata, a plant native to India. It has already been published that the Boswellic acids contained show anti-inflammatory and antioxidant properties in a variety of inflammatory diseases whose physio-pathological pathways are shared with those of prostatitis; phenolmicin P3 is a polyphenolic extract derived from beehive propolis, that also demonstrated anti-inflammatory and antioxidant properties in preclinical reports. It has also been reported to have the ability to create a microenvironment hostile to the reproduction of pathogenic bacteria. | Device | Phenolmicin P3 and Bosexil |
Primary outcome
IPSS
Time frame: 15 and 30 days post-operation
evaluation of effects of the suppository on irritative symptoms as assessed by eventual reduction in International Prostate Symptom Score (IPSS). Specifically, % reduction in absolute value of IPSS will be compared between the groups.
QoL
Time frame: 15 and 30 days post-operation
evaluation of effects of the suppository on Quality of life as assessed by eventual reduction in Quality of Life score. Specifically, % reduction in absolute value of QoL will be compared between the groups.
1 secondary outcome
Urinary Infection
Time frame: 15 and 30 days post-operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Derived from this study: PubMed 35151280Bertolo 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.
- Individual participant dataSharing planned: No. The analysis of the data obtained within the trial will be subject of scientific publication
Related trials for BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
Not yet recruitingPhase 4
Intermittent vs Daily Tamsulosin for LUTS/BPH
Lower Urinary Tract Symptoms, Prostate Obstruction
Active, not recruiting
WATER III: Aquablation vs. Transurethral Laser Enucleation of Large Prostates (80 - 180mL) in Benign Prostatic Hyperplasia
BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
RecruitingPhase 4
Optimizing Pain Control in Transurethral Resection of the Prostate
Pain, BPH With Urinary Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierluigi Bove, MD principal investigator
San Carlo di Nancy Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phenolmicin P3 and Bosexil suppository in people with BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms, run by San Carlo di Nancy Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IPSS (time frame: 15 and 30 days post-operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05130918, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.