Observational Study in Patients With Functional Benign Pr... | NCT02244320

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

NCT02244320

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Sep 19, 2014Estimated

Enrollment

4,150Actual

Phase

Not provided

Conditions

Prostatic Hyperplasia

Interventions

Tamsulosin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2002

Primary Completion Date

May 2003Actual

Completion Date

Not provided

First Submitted Date

Sep 18, 2014

First Submission Date that Met QC Criteria

Sep 18, 2014

First Posted Date

Sep 19, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2014

Last Update Posted Date

Sep 19, 2014Estimated

Description Module

Brief Summary

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))

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
functional BPH		patients with functional BPH who switched from phytotherapy to ALNA®	Drug: Tamsulosin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tamsulosin	Drug		functional BPH	ALNA®

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Change in sexual satisfaction rated on a 4-point scale		Day 1, 2 months
Change in maximum urinary flow rate (ml/sec)		Day 1, 2 months
Change in residual urine volume (ml)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with functional BPH symptoms recruited at urologist offices

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D011470	Prostatic Hyperplasia

Ancestor Terms

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077409	Tamsulosin

Ancestor Terms

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided