NCT00529386

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
9.3 years until next milestone

Results Posted

Study results publicly available

March 11, 2019

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

3.7 years

First QC Date

September 12, 2007

Results QC Date

April 4, 2018

Last Update Submit

March 21, 2019

Conditions

ProstatitisChronic Pain Syndrome

Keywords

prostatitisBotox

Outcome Measures

Primary Outcomes (1)

  • GRA

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

    12 weeks

Study Arms (1)

Botox

EXPERIMENTAL

300 IU botox

Drug: Botox

Interventions

BotoxDRUG

300 units

Also known as: Botulinem toxin
Botox

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant has signed and dated the appropriate Informed Consent document.
  • Participant must be ≥ 18 years of age.
  • 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.
  • Participants must report ejaculatory pain and/or perineal discomfort.
  • Participants must have pain or discomfort localized to perineum or prostate during physical examination.
  • 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).
  • Participant must have \> 8 on the pain domain sub-score of the NIH-CPSI.
  • Participant must have had empiric treatment with 4 weeks fluoroquinolone, and subsequently failed the antibiotic therapy.

You may not qualify if:

  • Participant has a history of prostate, bladder or urethral cancer.
  • Participant has inflammatory bowel disease (such as Crohn's disease or ulcerative colitis, but not irritable bowel syndrome).
  • Participant has undergone pelvic radiation or systemic chemotherapy.
  • Participant has undergone intravesical chemotherapy.
  • Participant has been treated for unilateral orchialgia without pelvic symptoms.
  • Participant has a current urethral stricture and/or bladder stones.
  • Participant has a neurological disease or disorder affecting the bladder.
  • Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
  • Participant has a documented UTI within the last 3 months.
  • Participant has evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 CFU/ml in mid-stream urine (VB2).
  • Participant has had previous intraprostatic injection of Botox.
  • Participant currently enrolled in an investigational study.
  • Participant interested in future fertility/fathering children.
  • Participant with urinary retention (PVR \>200cc).
  • Participant having had prostate surgery in the past 3 months.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Advanced Urological Research

Kingston, Ontario, K7L 3J7, Canada

Location

MeSH Terms

Conditions

Prostatitis

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Results Point of Contact

Title
J C Nickel
Organization
Dept of Urology, Queen's University
jcn@queensu.ca
613 548 2497

Study Officials

  • J. Curtis Nickel, MD FRCSC

    Queen's University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2007

First Posted

September 14, 2007

Study Start

January 1, 2006

Primary Completion

September 1, 2009

Study Completion

December 1, 2009

Last Updated

March 25, 2019

Results First Posted

March 11, 2019

Record last verified: 2019-03

Locations

CA(1)