Effect of alfuzosin hydrochloride on female primary bladder neck obstruction

ISRCTN	ISRCTN40295045
DOI	https://doi.org/10.1186/ISRCTN40295045
Secondary identifying numbers	N/A

Submission date: 01/05/2008
Registration date: 12/05/2008
Last edited: 12/05/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Anastasios Athanasopoulos
Scientific

Papadiamantopoulou 38 str
Patra
26225
Greece

Phone	+30 2610 994668
Email	tassos_athan@hotmail.com

Study information

Study design	Observational, case-control prospective study
Primary study design	Observational
Secondary study design	Case-control study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Effect of alpha-1 blocker alfuzosin hydrochloride on female primary bladder neck obstruction
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Alfuzosin hydrochloride
Primary outcome measure	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 study start date	01/02/2000
Completion date	30/05/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	25
Key inclusion criteria	1. Female patients older than 18 years old 2. Primary bladder neck obstruction
Key exclusion criteria	1. Mechanical causes of obstruction 2. Neurological disorders of micturition 3. Hypotension
Date of first enrolment	01/02/2000
Date of final enrolment	30/05/2008

Locations

Countries of recruitment

Greece

Study participating centre

Papadiamantopoulou 38 str

Patra
26225
Greece

Sponsor information

University Hospital of Patras (Greece)
Hospital/treatment centre

Department of Urology
Rio-Patra
Patra
26500
Greece

Phone	+30 2610 999385
Email	anathan@upatras.gr
Website	http://www.upatras.gr/
"ROR"	https://ror.org/03c3d1v10

Funders

Funder type

Hospital/treatment centre

University Hospital of Patras (Greece)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan