Contact information
Type
Scientific
Primary contact
Dr L M O de Kort
ORCID ID
Contact details
University Medical Center Utrecht
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 2508079
l.m.o.dekort@umcutrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
BOP1
Study hypothesis
Botulinum toxin type A injection of the prostate causes relaxation and cellular apoptosis and by this way will relieve lower urinary tract symptoms in patients with benign prostatic hyperplasia.
Ethics approval
Not provided at time of registration
Study design
Prospective clinical trial
Primary study design
Interventional
Secondary study design
Single-centre
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Benign prostatic hyperplasia
Intervention
Transrectal intraprostatic injection with botulinum toxin type A.
Intervention type
Drug
Phase
Not Specified
Drug names
Botulinum toxin type A
Primary outcome measures
Symptom relief according to the International Prostatic Symptom Score (IPSS).
Secondary outcome measures
1. Urodynamic obstruction (according to Schafer)
2. Post-void residual
3. Decrease in prostate volume
4. Histologic change after one month
5. Prostate Specific Antigen change
6. Other treatment needed
Overall trial start date
01/10/2006
Overall trial end date
31/03/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age more than 55
2. Signed informed consent
3. Lower Urinary Tract Symptoms (LUTS) with International Prostatic Symptom Score (IPSS) more than seven
4. Insufficient response to oral medication
5. Prostatic volume 30 to 50 ml
6. Urodynamic infravesical obstruction more than grade II according to Schafer
7. Willing and able to fill out questionnaires and voiding diaries
8. Willing and able to attend proposed investigations
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
20
Participant exclusion criteria
1. Neuropathic bladder dysfunction
2. Prostatic carcinoma
3. Coagulation disorder
4. Urinary tract infection
5. Bladder calculus
6. Post-renal renal insufficiency
7. Myopathic disorder
8. Anatomical defects preventing transrectal approach
Recruitment start date
01/10/2006
Recruitment end date
31/03/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Utrecht
Utrecht
3508 GA
Netherlands
Funders
Funder type
Industry
Funder name
Allergan (International)
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