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
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