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

Phase 4

Completed

• Conditions: Lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH); ower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH); Urological and Genital Diseases

• Registration Number: ISRCTN11815680
• Lead Sponsor: Pierre Fabre Ibérica S.A.

Brief Summary

2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/26810324 results (added 29/11/2019) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35806900/ (added 27/02/2023) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34588509/ (added 27/02/2023) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35207238/ (added 27/02/2023) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/32917008/ (added 27/02/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2011-06-30
• Study Start: 2020-01-22
• Last Update Posted: 13 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 1638

Inclusion Criteria

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

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified