Trial · NCT06181175
Treatment of BPH With CO2 Serenoa +PEA as Monotherapy or in Combination With Tamsulosin: ProSeRePEA Trial
NCT06181175, Not applicable, Unknown, Azienda Ospedaliero Universitaria Maggiore della Carita
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of BPH With CO2 Serenoa +PEA as Monotherapy or in Combination With Tamsulosin: ProSeRePEA Trial. Trials, record NCT06181175. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06181175
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of BPH With CO2 Serenoa +PEA as Monotherapy or in Combination With Tamsulosin: ProSeRePEA Trial
- NCT number
- NCT06181175
- Status
- Unknown
- Phases
- Not applicable
- Enrollment
- 250 participants, estimated
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Conditions
- Benign Prostatic Hyperplasia, Urinary Obstruction, Lower Urinary Tract Symptoms
- Interventions
- PEAPROSTIL 600 + Tamsulosin 0.4 mg, Tamsulosin 0.4 mg, PEAPROSTIL 600 mg
- First posted
- 2023-12-26
- Last updated
- 2023-12-26
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of treatment of combination therapy group vs tamsulosin group in International Prostate Symptoms Score questionnaire | 1 year | comparing patients receiving tamsulosin + peaprostil combination therapy (Arm 1) versus patients receiving tamsulosin monotherapy (Arm 3) in terms of International Prostate Symptoms Score (scale 0-35) at 1,3,6 and 12 months. (0 point no symptoms, 35 points many symptoms) |
| Primary | Efficacy of treatment of combination therapy group vs tamsulosin group in Quality of Life questionnaire | 1 year | comparing patients receiving tamsulosin + peaprostil combination therapy (Arm 1) versus patients receiving tamsulosin monotherapy (Arm 3) in terms of Quality of life (0-6 points) at 1,3,6 and 12 months (0 point good quality of life, 6 points bad quality of life) |
| Secondary | Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of Short Form Health Survey-36 questionnaires | 1 year | comparing patients receiving tamsulosin + peaprostil combination therapy (Arm 1) versus patients receiving tamsulosin monotherapy (Arm 3) in terms of Short Form Health Survey-36 (36 questions) at 1,3,6 and 12 months |
| Secondary | Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of uroflowmetry with maximum urinary flow (ml/s) | 1 year | comparing patients receiving tamsulosin + peaprostil combination therapy (Arm 1) versus patients receiving tamsulosin monotherapy (Arm 3) in terms of maximum urinary flow (ml/s) at 1,3,6 and 12 months |
| Secondary | Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of post voided volume (ml) | 1 year | comparing patients receiving tamsulosin + peaprostil combination therapy (Arm 1) versus patients receiving tamsulosin monotherapy (Arm 3) in terms of post voided volume (ml) at 1,3,6 and 12 months |
| Secondary | Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of prostate volume (gr) | 1 year | comparing patients receiving tamsulosin + peaprostil combination therapy (Arm 1) versus patients receiving tamsulosin monotherapy (Arm 3) in terms of prostate volume (gr) at 6 and 12 months |
| Secondary | Efficacy of treatment in combination therapy group vs peaprostil group and peaprostil group vs tamsulosin group in terms of International Prostate Symptoms Score | 1 year | comparing patients receiving combination therapy group (Arm1) vs peaprostil group (Arm2) and peaprostil group (Arm2) vs tamsulosin alone (Arm 3) in terms of International Prostate Symptoms Score (scale 0-35) at 1,3,6 and 12 months. (0 point no symptoms, 35 points many symptoms) |
| Secondary | Efficacy of treatment in combination therapy group vs peaprostil group and peaprostil group vs tamsulosin group in terms of Quality of life | 1 year | comparing patients receiving combination therapy group (Arm1) vs peaprostil group (Arm2) and peaprostil group (Arm2) vs tamsulosin alone (Arm 3) in terms of Quality of life (QoL) (0-6 points) at 1,3,6 and 12 months (0 point good quality of life, 6 points bad quality of life) |
| Secondary | Efficacy of treatment in combination therapy group vs peaprostil group and peaprostil group vs tamsulosin group in terms of Short Form Health Survey-36 questionnaires | 1 year | comparing patients receiving combination therapy group (Arm1) vs peaprostil group (Arm2) and peaprostil group (Arm2) vs tamsulosin alone (Arm 3) in terms of Short Form Health Survey-36 (36 questions) at 1,3,6 and 12 months |
| Secondary | Efficacy of treatment in combination therapy group vs peaprostil group and peaprostil group vs tamsulosin group in terms of uroflowmetry with maximum urinary flow (ml/s) | 1 year | comparing patients receiving combination therapy group (Arm1) vs peaprostil group (Arm2) and peaprostil group (Arm2) vs tamsulosin alone (Arm 3) in terms of maximum urinary flow (ml/s) at 1,3,6 and 12 months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06181175
GET https://conductscience.org/api/trials/v1/NCT06181175/registered