Condition category
Urological and Genital Diseases
Date applied
01/05/2008
Date assigned
12/05/2008
Last edited
12/05/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Anastasios Athanasopoulos

ORCID ID

Contact details

Papadiamantopoulou 38 str
Patra
26225
Greece
+30 2610 994668
tassos_athan@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effect of alpha-1 blocker alfuzosin hydrochloride on female primary bladder neck obstruction

Acronym

Study hypothesis

To assess the effect of the selective alpha-1 blocker alfuzosin hydrochloride on urodynamic and quality of life issues of female patients with functional bladder outlet obstruction (BOO) and especially primary bladder neck obstruction (PBNO).

Ethics approval

At the time of recruitment for this trial (2000) no formal approval was required for a phase IV trial. Patients were informed orally and informed consent was required.

Study design

Observational, case-control prospective study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Female primary bladder neck obstruction (PBNO)

Intervention

Pre-treatment:
1. Urodynamic study including free flow, cystometry, pressure flow study and profilometry, and
2. Bother Score questionnaire

Post-treatment:
The same as pre-treatment plus a question about the Global Assessment of the treatment result.

Treatment:
The dosage of the alfuzosin hydrochloride was 5 mg twice daily for eight weeks. Patients were followed up for eight weeks.

Intervention type

Drug

Phase

Not Specified

Drug names

Alfuzosin hydrochloride

Primary outcome measures

Urodynamic parameters related with obstruction (voiding phase). Primary and secondary outcomes were measured only at the eight-week visit (study closure).

Secondary outcome measures

1. Measurement of Bother Score Index
2. Global Assessment of Quality of Life
3. Urodynamic parameters related with storage phase

Primary and secondary outcomes were measured only at the 8-week visit (study closure).

Overall trial start date

01/02/2000

Overall trial end date

30/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female patients older than 18 years old
2. Primary bladder neck obstruction

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

25

Participant exclusion criteria

1. Mechanical causes of obstruction
2. Neurological disorders of micturition
3. Hypotension

Recruitment start date

01/02/2000

Recruitment end date

30/05/2008

Locations

Countries of recruitment

Greece

Trial participating centre

Papadiamantopoulou 38 str
Patra
26225
Greece

Sponsor information

Organisation

University Hospital of Patras (Greece)

Sponsor details

Department of Urology
Rio-Patra
Patra
26500
Greece
+30 2610 999385
anathan@upatras.gr

Sponsor type

Hospital/treatment centre

Website

http://www.upatras.gr/

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital of Patras (Greece)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes