Quality of life study in patients with urinary symptoms related to prostate enlargement and its change over time according to the received treatment

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN11815680

Enrollment

1638

Registered

2020-01-22

Start date

2009-09-01

Completion date

Unknown

Last updated

2023-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) Urological and Genital Diseases Lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH)

Interventions

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 stu

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

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. =40 years 2. Diagnosis of LUTS/BPH 3. IPSS score of =8 4. Signed informed consent

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026