Botox for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Condition: Prostatitis; Chronic Pain Syndrome
MeSH terms: Prostatitis; Syndrome; Chronic Pain; Pelvic Pain; Somatoform Disorders
Intervention: Botox
Intervention description: 300 units
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: prostatitis; Botox

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).
    

Eligibility criteria:

        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).