Chronic Pain Syndrome, Prostatitis
Conditions
Keywords
prostatitis, Botox
Brief summary
The objective of this study is to evaluate the safety and efficacy of intraprostatic injection of Botox for the treatment of men diagnosed with chronic nonbacterial prostatitis/chronic pelvic pain syndrome (CP/CPPS).
Detailed description
This is a prospective open label study examining the efficacy and safety of intraprostatic Botox . Men with a clinical diagnosis of chronic nonbacterial prostatitis/CPPS will be treated with intraprostatic Botox™ and followed for 12 weeks (primary efficacy analyses), and 24 weeks (long term follow-up) for responders. It is proposed that a total of 40 males will be enrolled. There will be seven (7) research clinic visits and two phone contacts: Visit 1 (screening), Visit 2 (baseline/treatment), Visit 3 (2-week safety evaluation - clinic contact), Visit 4 (4-week safety evaluation - phone contact), Visit 5 (6-week interim efficacy/safety), Visit 6 (12-week primary endpoint evaluation), Visit 7 (14-week clinic follow up), Visit 8 (16 week phone contact) and Visit 9 (24-week clinic close out). Outcome measures include Chronic Prostatitis Symptom Index (CPSI 0-35), NRS pain (0-10), Global Response Assessment (GRA) at 12 weeks. Safety to be monitored during the study.
Interventions
DRUGBotox
300 units
Sponsors
Allergan
Queen's University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant has signed and dated the appropriate Informed Consent document. 2. Participant must be ≥ 18 years of age. 3. Participant has had a clinical diagnosis of chronic nonbacterial prostatitis (chronic pelvic pain syndrome) (CPPS) defined as symptoms of discomfort or pain in the perineal or pelvic region for at least the past 3 months without evidence of bacterial infection. 4. Participants must report ejaculatory pain and/or perineal discomfort. 5. Participants must have pain or discomfort localized to perineum or prostate during physical examination. 6. Participants must have an aggregate score of greater than or equal to 15 on the National Institutes of Health chronic prostatitis symptom index (NIH-CPSI). 7. Participant must have \> 8 on the pain domain sub-score of the NIH-CPSI. 8. Participant must have had empiric treatment with 4 weeks fluoroquinolone, and subsequently failed the antibiotic therapy.
Exclusion criteria
1. Participant has a history of prostate, bladder or urethral cancer. 2. Participant has inflammatory bowel disease (such as Crohn's disease or ulcerative colitis, but not irritable bowel syndrome). 3. Participant has undergone pelvic radiation or systemic chemotherapy. 4. Participant has undergone intravesical chemotherapy. 5. Participant has been treated for unilateral orchialgia without pelvic symptoms. 6. Participant has a current urethral stricture and/or bladder stones. 7. Participant has a neurological disease or disorder affecting the bladder. 8. Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol. 9. Participant has a documented UTI within the last 3 months. 10. Participant has evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 CFU/ml in mid-stream urine (VB2). 11. Participant has had previous intraprostatic injection of Botox. 12. Participant currently enrolled in an investigational study. 13. Participant interested in future fertility/fathering children. 14. Participant with urinary retention (PVR \>200cc). 15. Participant having had prostate surgery in the past 3 months. 16. Participant having had minimally invasive surgical therapy for BPH. 17. Participant with a cystostomy or nephrostomy. 18. Participant with penile or urinary sphincter implants. 19. Participant with previous rectal surgery, current rectal disease or peri-rectal inflammatory disorders except hemorrhoidectomy. 20. Participant with PSA \>10 ng/ml(PSA range 4-10, biopsy at PI discretion (deferral).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GRA | 12 weeks | At 12 weeks there were no GRA responders. Study stopped because of futility. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Botox 300 IU botox
Botox: 300 units | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Botox |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Region of Enrollment Canada | 7 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
GRA
At 12 weeks there were no GRA responders. Study stopped because of futility.
Time frame: 12 weeks
Population: 7 CPCPPS patients enrolled and analysed before stopping study because of futility
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Botox | GRA | 0 Participants |