Quality of life study in patients with urinary symptoms related to prostate enlargement and its change over time according to the received treatment
| ISRCTN | ISRCTN11815680 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11815680 |
| Secondary identifying numbers | HBP-EPI-2008-01 |
- Submission date
- 29/11/2019
- Registration date
- 22/01/2020
- Last edited
- 27/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
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
Contact information
Scientific
Ramon Trias Fargas, 7-9, 3º
Barcelona
08027
Spain
 ORCID ID |
0000-0003-3633-8778 |
|---|---|
| Phone | +34670925478 |
| jose.manasanch@pierre-fabre.com |
Study information
| Study design | Longitudinal prospective observational multicenter study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | No participant information sheet available |
| 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 |
| 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(s) | 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 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | 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 study start date | 10/02/2009 |
| Overall study end date | 30/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 1638 |
| Total final enrolment | 1638 |
| Participant inclusion criteria | 1. ≥40 years 2. Diagnosis of LUTS/BPH 3. IPSS score of ≥8 4. Signed informed consent |
| 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
Study participating centres
Madrid
28222
Spain
Bilbao
48013
Spain
Barcelona
08208
Spain
Cádiz
11510
Spain
Barcelona
08006
Spain
Madrid
28003
Spain
Donostia
20012
Spain
Sponsor information
Industry
Ramon Trias Fargas, 7-9, 3º
Barcelona
08005
Spain
| Phone | +34 93 483 30 00 |
|---|---|
| informacion_general@pierre-fabre.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/05/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2016 | 29/11/2019 | Yes | No |
| Other publications | 22/06/2022 | 27/02/2023 | Yes | No | |
| Other publications | 29/09/2021 | 27/02/2023 | Yes | No | |
| Other publications | 12/02/2022 | 27/02/2023 | Yes | No | |
| Other publications | 09/09/2020 | 27/02/2023 | Yes | No |
Editorial Notes
27/02/2023: Publication references added.
03/12/2019: Trial’s existence confirmed by Ethical and Clinical Investigation Committee of Puerta de Hierra Majadahonda University Hospital
