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 |
| Protocol serial number | NL739, NTR749 |
| Sponsor | University Medical Center Utrecht (UMCU) (The Netherlands) |
| Funder | Allergan (International) |
- 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
Scientific
University Medical Center Utrecht
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)30 2508079 |
|---|---|
| l.m.o.dekort@umcutrecht.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective clinical trial |
| Secondary study design | Single-centre |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Botulinum toxin type A |
| Primary outcome measure(s) |
Symptom relief according to the International Prostatic Symptom Score (IPSS). |
| Key secondary outcome measure(s) |
1. Urodynamic obstruction (according to Schafer) |
| Completion date | 31/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 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
3508 GA
Netherlands
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? |
|---|---|---|---|---|---|
| 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.
