Condition category
Urological and Genital Diseases
Date applied
29/11/2019
Date assigned
22/01/2020
Last edited
22/01/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Background and study aims
The purpose of the QUALIPROST study is to measure how urinary symptoms related with the prostate enlargement influence the quality of life of the patients and also how the quality of life is improved when these symptoms are treated with different drugs in a current clinical practice.

Who can participate?
Patients of 40 years and over suffering from urinary symptoms affecting their normal life

What does the study involve?
Patients will be treated as usual by their physician. Before the start of treatment and after six months, data will be collected.
To measure the evolution of the symptoms a questionnaire called International Prostate Symptom Score will be used. The quality of life will be also measured by another questionnaire named Benign Prostatic Hyperplasia Impact Index.
Side effects are also collected and studied as it could affect the quality of life when they appear caused by a specific drug.

What are the possible benefits and risks of participating?
Benefits: Participants will be closely followed by their doctor as he/she will collect specific data related to troubles and how they affect quality of life.
Risks: none anticipated.

Where is the study run from?
1. Hospital Universitario Puerta de Hierro Majadahonda, Spain
2. Hospital Universitario Basurto, Spain
3. Hospital Universitari Parc Taulí, Spain
4. Hospital Universitario Puerto Real, Spain
5. Hospital El Pilar, Spain
6. Instituto Urológico Madrileño, Spain
7. Muganix Servicios Médicos, Spain

When is the study starting and how long is it expected to run for?
September 2009 to June 2011

Who is funding the study?
Pierre Fabre Ibérica S.A., Spain

Who is the main contact?
José Manasanch
jose.manasanch@pierre-fabre.com

Trial website

Contact information

Type

Scientific

Primary contact

Mr José Manasanch

ORCID ID

http://orcid.org/0000-0003-3633-8778

Contact details

Ramon Trias Fargas
7-9

Barcelona
08027
Spain
+34670925478
jose.manasanch@pierre-fabre.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

HBP-EPI-2008-01

Study information

Scientific title

Quality of life evaluation in patients with LUTS/BPH and its change over time in real‑life practice
according to the different treatments—the QUALIPROST study

Acronym

QUALIPROST

Study hypothesis

The aim of the study is to investigate the LUTS/BPH patients' quality of life in a 6-month period of follow-up in current clinical practice related to its treatment

Ethics approval

Approved 27/04/2009, Ethical and Clinical Investigation Committee of Puerta de Hierra Majadahonda University Hospital (Joaquín Rodrigo 2, 28222 ‐ Majadahonda, Madrid, Spain; +34 91 191 76 62; secreceic.hpth@salud.madrid.org), ref: 23/2009

Study design

Longitudinal prospective observational multicenter study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Other

Trial type

Quality of life

Patient information sheet

No participant information sheet available

Condition

Lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH)

Intervention

This open-label study is carried out in urology outpatient clinics. Patients are ≥40 years of age with an International Prostate Symptom Score (IPSS) score ≥8.

As an observational study, investigators can prescribe any of the commercially available treatments according to their current practice or no treatment.
The prescribed drugs were:
Alpha-blockers (mainly tamsulosin, at a dose of 0.4 mg daily)
Finasteride (5 mg/day)
Dutasteride (0.5 mg/day)
Pygeum africanum extract (Tebetane compuesto® at a dose of 60 mg/day)
Hexanic extract of Serenoa repens (Permixon®; at a dose of 320 mg daily)

QoL and symptoms are measured at baseline and 6 months using the Benign Prostatic Hyperplasia Impact Index (BII) and the IPSS

Intervention type

Drug

Phase

Phase IV

Drug names

Alpha-blockers (mainly tamsulosin, at a dose of 0.4 mg daily)
Finasteride (5 mg/day)
Dutasteride (0.5 mg/day)
Pygeum africanum extract (Tebetane compuesto® at a dose of 60 mg/day)
Hexanic extract of Serenoa repens (Permixon®; at a dose of 320 mg daily)

Primary outcome measure

Quality of life, measured by means of the BPH Impact Index questionnaire at the time of the patient inclusion and at 6-months of follow-up.

Secondary outcome measures

1. Evolution of the LUTS/BPH, using the International Prostate Symptom Score (IPSS) at baseline and at the 6-month follow-up visit
2. Sociodemographic data collected at baseline, including age, weight, and height
Collected at end of study period:
3. Clinical data collected: date of initiation of urinary symptoms, year of LUTS/BPH diagnosis, and severity of BPH according to IPSS score
4. Data on diagnostic tests (digital rectal examination, prostate volume, Qmax, urine analysis, serum analysis, PSA)
5. Treatment received (yes/no, alpha-blockers, 5-alpha-reductase inhibitors, phytotherapy, other)
6. Comorbidities: high blood pressure, diabetes, dyslipidemia, etc., as well as treatment for co-morbidities
7. Side effects associated with treatment were recorded at the follow-up visit
8. Treatment compliance, by means of the Haynes–Sackett questionnaire

Overall trial start date

10/02/2009

Overall trial end date

30/06/2011

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. ≥40 years
2. Diagnosis of LUTS/BPH
3. IPSS score of ≥8
4. Signed informed consent

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

1638

Total final enrolment

1638

Participant exclusion criteria

1. Drug treatment for BPH in the 6 months prior to inclusion or currently receive any drug treatment with a known effect on BPH symptoms (such as diuretics, antihistamines, or tricyclic antidepressants) for any length of time in the 4 weeks prior to inclusion
2. Other urinary disorders (prostatitis, urinary incontinence, urethral strictures, or prostate cancer) or previously undergone surgery of the lower urinary tract
3. Neurological, physical or psychiatric disturbances preventing to fill in IPSS and/or BII questionnaires.

Recruitment start date

01/09/2009

Recruitment end date

16/12/2010

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Universitario Puerta de Hierro Majadahonda
Manuel de Falla, 1
Madrid
28222
Spain

Trial participating centre

Hospital Universitario Basurto
Avda. Montevideo, 18
Bilbao
48013
Spain

Trial participating centre

Hospital Universitari Parc Taulí
Parc Taulí, 1
Barcelona
08208
Spain

Trial participating centre

Hospital Universitario Puerto Real
Romería, 7
Cádiz
11510
Spain

Trial participating centre

Hospital El Pilar
Balmes, 271
Barcelona
08006
Spain

Trial participating centre

Instituto Urológico Madrileño
Av. del Valle, 13
Madrid
28003
Spain

Trial participating centre

Muganix Servicios Médicos
Alkolea Parkea, 7
Donostia
20012
Spain

Sponsor information

Organisation

Pierre Fabre Ibérica S.A.

Sponsor details

Ramon Trias Fargas
7-9

Barcelona
08005
Spain
+34 93 483 30 00
informacion_general@pierre-fabre.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Pierre Fabre Ibérica S.A.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

01/05/2016

Participant level data

Other

Basic results (scientific)

Publication list

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/26810324 (added 29/11/2019)

Publication citations

Additional files

Editorial Notes

03/12/2019: Trial’s existence confirmed by Ethical and Clinical Investigation Committee of Puerta de Hierra Majadahonda University Hospital