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TerminatedNCT00529386Updated Mar 25, 2019Results posted

Botox for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

A Phase 1 interventional study of Botox in Prostatitis and Chronic Pain Syndrome, sponsored by Queen's University. Terminated at 1 site in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-25.

Sponsored by Queen's University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study 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).

Read the 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.

02

Conditions studied

  • Prostatitis
  • Chronic Pain Syndrome

Keywords

  • prostatitis
  • Botox
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts 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

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).
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Botox

    300 IU botox

    Drug: Botox

Interventions

  • DrugBotox

    300 units

    Also known as: Botulinem toxin

05

What researchers measure

Primary outcomes

  1. GRA

    At 12 weeks there were no GRA responders. Study stopped because of futility.

    Time frame: 12 weeks

06

Results

Posted Mar 11, 2019

Participant flow

Participant flow — Overall Study
MilestoneBotox
Started7
Completed6
Not completed1
Withdrew: Lost to follow-up1

Outcome measures

PrimaryGRA

At 12 weeks there were no GRA responders. Study stopped because of futility.

Time frame:
12 weeks
Reported as:
Count of participants · Participants
GRA
ParticipantsBotox
GRA0

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Botox—0/7 (0%)0/7 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Botox
<=18 years0
Between 18 and 65 years7
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Botox
Female0
Male7
Region of Enrollment
Region of Enrollment(participants)Botox
Canada7
07

Study locations

1 site
  • Centre for Advanced Urological Research
    Kingston, Ontario K7L 3J7, Canada
08

Registry details

Key details

Study ID
NCT00529386
Lead sponsor
Queen's University
Collaborators
Allergan
Responsible party
Dr. J. Curtis Nickel (Principal Investigator, Queen's University) — Principal investigator
First posted
Sep 14, 2007
Start date
Jan 2006
Primary completion
Sep 2009
Completion
Dec 2009
Results posted
Mar 11, 2019
Last update
Mar 25, 2019

Study contacts

J. Curtis Nickel, MD FRCSC
principal investigator · Queen's University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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