The Impact of Alna® Ocas® on Nocturia in Patients With Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia (LUTS/BPH)

Study to assess efficacy, tolerability and safety parameters of a three month ALNA®OCAS® -treatment with special respect to nocturia

Completed

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Key information

Conditions

Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Urogenital Diseases

Sex eligibility

Male

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Indication for treatment with ALNA®OCAS® according to the prescribing information for a minimum period of three months

Exclusion criteria

Patients fulfilling one of the general or specific contraindications listed in the ALNA®OCAS® Summary of Product Characteristics (SPC), particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredient of the product, orthostatic dysregulation or severe liver insufficiency could not be included in the Post Marketing Study (PMS) study

Treatment and study plan

ALNA®OCAS®

Drug

Primary outcomes

Change from Baseline in International Prostatic Symptom Score (IPSS) by means of a patient questionnaire

Time frame: Baseline, after 3 months
Change from Baseline in Nocturia quality of life by means of a patient questionnaire

Time frame: Baseline, after 3 months

Secondary outcomes

Change from Baseline in Maximum urinary flow rate (Qmax)

Time frame: Baseline, after 3 months
Change from Baseline in residual urine volume

Time frame: Baseline, after 3 months
Assessment of tolerability by investigator on 4-point scale

Time frame: after 3 months
Number of patients with adverse events

Time frame: up to 3 months

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Important dates

Study start: 2005
Primary completion: 2006
First posted: Sep 19, 2014
Registry last updated: Sep 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed