Clinical and histologic effect of transrectal intraprostatic injections with botulinum toxin A in patients with lower urinary tract symptoms caused by benign prostatic hyperplasia

ISRCTN	ISRCTN42633050
DOI	https://doi.org/10.1186/ISRCTN42633050
Secondary identifying numbers	NL739, NTR749

Submission date: 22/11/2006
Registration date: 22/11/2006
Last edited: 06/01/2021

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

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr L M O de Kort
Scientific

University Medical Center Utrecht
P.O. Box 85500
Utrecht
3508 GA
Netherlands

Phone	+31 (0)30 2508079
Email	l.m.o.dekort@umcutrecht.nl

Study information

Study design	Prospective clinical trial
Primary study design	Interventional
Secondary study design	Single-centre
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Clinical and histologic effect of transrectal intraprostatic injections with botulinum toxin A in patients with lower urinary tract symptoms caused by benign prostatic hyperplasia
Study acronym	BOP1
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Benign prostatic hyperplasia
Intervention	Transrectal intraprostatic injection with botulinum toxin type A.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Botulinum toxin type A
Primary outcome measure	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 study start date	01/10/2006
Completion date	31/03/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	20
Total final enrolment	15
Key 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
Key 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
Date of first enrolment	01/10/2006
Date of final enrolment	31/03/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Center Utrecht

Utrecht
3508 GA
Netherlands

Sponsor information

University Medical Center Utrecht (UMCU) (The Netherlands)
Hospital/treatment centre

P.O. Box 85500
Utrecht
3508 GA
Netherlands

"ROR"	https://ror.org/0575yy874

Funders

Funder type

Industry

Allergan (International)

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2012	06/01/2021	Yes	No

Editorial Notes

06/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.