|
ISRCTN
|
ISRCTN40295045
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Effect of alfuzosin hydrochloride on female primary bladder neck obstruction
|
|
Scientific title
|
Effect of alpha-1 blocker alfuzosin hydrochloride on female primary bladder neck obstruction
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N/A
|
|
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
|
|
Countries of recruitment
|
Greece
|
|
Disease/condition/study domain
|
Female primary bladder neck obstruction (PBNO)
|
|
Participants - inclusion criteria
|
1. Female patients older than 18 years old
2. Primary bladder neck obstruction
|
|
Participants - exclusion criteria
|
1. Mechanical causes of obstruction
2. Neurological disorders of micturition
3. Hypotension
|
|
Anticipated start date
|
01/02/2000
|
|
Anticipated end date
|
30/05/2008
|
|
Status of trial
|
Completed
|
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
25
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
Urodynamic parameters related with obstruction (voiding phase). Primary and secondary outcomes were measured only at the eight-week visit (study closure).
|
|
Secondary outcome measure(s)
|
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).
|
|
Sources of funding
|
University Hospital of Patras (Greece)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Prof
Anastasios
Athanasopoulos
|
|
Address
|
Papadiamantopoulou 38 str
|
|
City/town
|
Patra
|
|
Zip/Postcode
|
26225
|
|
Country
|
Greece
|
|
Tel
|
+30 2610 994668
|
|
Fax
|
+30 2610 994668
|
|
Email
|
tassos_athan@hotmail.com
|
|
Sponsor
|
University Hospital of Patras (Greece)
|
|
Address
|
Department of Urology
Rio-Patra
|
|
City/town
|
Patra
|
|
Zip/Postcode
|
26500
|
|
Country
|
Greece
|
|
Tel
|
+30 2610 999385
|
|
Fax
|
+30 2610 993981
|
|
Email
|
anathan@upatras.gr
|
|
Sponsor website:
|
http://www.upatras.gr/
|
|
Date applied
|
01/05/2008
|
|
Last edited
|
12/05/2008
|
|
Date ISRCTN assigned
|
12/05/2008
|
