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

NCT02245542 | Completed

• 1 other identifier: 527.68
• Study Type: observational
• Target: 5,775
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (2)

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

  Baseline, after 3 months

• Change from Baseline in Nocturia quality of life by means of a patient questionnaire

  Baseline, after 3 months

Secondary Outcomes (4)

• Change from Baseline in Maximum urinary flow rate (Qmax)

  Baseline, after 3 months

• Change from Baseline in residual urine volume

  Baseline, after 3 months

• Assessment of tolerability by investigator on 4-point scale

  after 3 months

• Number of patients with adverse events

  up to 3 months

Study Arms (1)

BPH patients

Drug: ALNA®OCAS®

Interventions

ALNA®OCAS® DRUG

BPH patients

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

BPH patients who are indicated for treatment with ALNA®OCAS® with special respect to nocturia recruited at urologists

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 19, 2014
• Study Start: April 1, 2005
• Primary Completion: February 1, 2006
• Last Updated: September 19, 2014

Record last verified: 2014-09