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Completed

NCT Number: NCT02244320

Observational Study in Patients With Functional 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))

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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

  • 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

Treatment and study plan

Tamsulosin

Drug

Other names: ALNA®

Primary outcomes

  1. Change in IPSS sum score

    Time frame: Day 1, 2 months

  2. Change in Quality-of-Life Index (QoL) rated on a 7-point scale

    Time frame: Day 1, 2 months

Secondary outcomes

  1. Change in sexual satisfaction rated on a 4-point scale

    Time frame: Day 1, 2 months

  2. Change in maximum urinary flow rate (ml/sec)

    Time frame: Day 1, 2 months

  3. Change in residual urine volume (ml)

    Time frame: Day 1, 2 months

  4. Patient's global assessment of the preceding phytotherapy on a 3-point scale

    Time frame: Day 1

  5. Patient's global assessment of the therapy with ALNA® on a 3-point scale

    Time frame: after 2 months

  6. Efficacy assessment of the preceding phytotherapy by physician rated on 4-point scale

    Time frame: Day 1

  7. Efficacy assessment of the therapy with ALNA® by physician rated on 4-point scale

    Time frame: after 2 months

  8. Tolerability assessment of the preceding phytotherapy by physician rated on 4-point scale

    Time frame: Day 1

  9. Tolerability assessment of the therapy with ALNA® by physician rated on 4-point scale

    Time frame: after 2 months

  10. Number of patients with adverse drug reactions (ADR)

    Time frame: up to 2 months

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2003
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.

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