Condition category
Urological and Genital Diseases
Date applied
22/11/2006
Date assigned
22/11/2006
Last edited
23/11/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

University Medical Center Utrecht (UMCU) (The Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes