Effect of alfuzosin hydrochloride on female primary bladder neck obstruction
| ISRCTN | ISRCTN40295045 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40295045 |
| Protocol serial number | N/A |
| Sponsor | University Hospital of Patras (Greece) |
| Funder | University Hospital of Patras (Greece) |
- 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
Scientific
Papadiamantopoulou 38 str
Patra
26225
Greece
| Phone | +30 2610 994668 |
|---|---|
| tassos_athan@hotmail.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational, case-control prospective study |
| Secondary study design | Case-control study |
| Study type | Participant 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Alfuzosin hydrochloride |
| 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). |
| Key secondary outcome measure(s) |
1. Measurement of Bother Score Index |
| Completion date | 30/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 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
26225
Greece
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
