Observational Study in Patients With Functional Benign Prostatic Hyperplasia Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin)

September 18, 2014 updated by: Boehringer Ingelheim

Observational Study in Patients With Functional BPH (Benign Prostatic Hyperplasia) Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin)

The objective of the observational study were to investigate the switch from phytotherapy to ALNA® after at least 4 weeks of phytotherapy and still presented with a symptom sum score of ≥ 8 points (International Prostate Symptom Score (IPSS))

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients with functional BPH symptoms recruited at urologist offices

Description

Inclusion Criteria:

  • Patients suffering from BPH symptoms
  • Preceding treatment with a phytotherapeutic for at least 4 weeks
  • IPSS sum score ≥ 8 points prior to treatment start with ALNA®
  • Indication for a switch to treatment with ALNA® for a minimum period of 2 months

Exclusion Criteria:

  • Patients fulfilling one of the general or specific contraindications listed in the ALNA® Summary of Product Characteristic, particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredient of the product, orthostatic dysregulation or severe liver insufficiency
  • Patients receiving ALNA® within the 4 weeks prior to the start of the present observational study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
functional BPH
patients with functional BPH who switched from phytotherapy to ALNA®
Other Names:
  • ALNA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in IPSS sum score
Time Frame: Day 1, 2 months
Day 1, 2 months
Change in Quality-of-Life Index (QoL) rated on a 7-point scale
Time Frame: Day 1, 2 months
Day 1, 2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in sexual satisfaction rated on a 4-point scale
Time Frame: Day 1, 2 months
Day 1, 2 months
Change in maximum urinary flow rate (ml/sec)
Time Frame: Day 1, 2 months
Day 1, 2 months
Change in residual urine volume (ml)
Time Frame: Day 1, 2 months
Day 1, 2 months
Patient's global assessment of the preceding phytotherapy on a 3-point scale
Time Frame: Day 1
Day 1
Patient's global assessment of the therapy with ALNA® on a 3-point scale
Time Frame: after 2 months
after 2 months
Efficacy assessment of the preceding phytotherapy by physician rated on 4-point scale
Time Frame: Day 1
Day 1
Efficacy assessment of the therapy with ALNA® by physician rated on 4-point scale
Time Frame: after 2 months
after 2 months
Tolerability assessment of the preceding phytotherapy by physician rated on 4-point scale
Time Frame: Day 1
Day 1
Tolerability assessment of the therapy with ALNA® by physician rated on 4-point scale
Time Frame: after 2 months
after 2 months
Number of patients with adverse drug reactions (ADR)
Time Frame: up to 2 months
up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

May 1, 2003

Study Registration Dates

First Submitted

September 18, 2014

First Submitted That Met QC Criteria

September 18, 2014

First Posted (Estimate)

September 19, 2014

Study Record Updates

Last Update Posted (Estimate)

September 19, 2014

Last Update Submitted That Met QC Criteria

September 18, 2014

Last Verified

September 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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