NCT00464373

Brief Summary

The aim of this randomized placebo-controlled study is to demonstrate the efficiency and safety of the injection of Botulinum Toxin Type A (200 Units) into the external urethral sphincter for the treatment of chronic prostatitis/chronic pelvic pain.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2007

Longer than P75 for phase_3

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

April 1, 2007

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2007

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

February 3, 2014

Status Verified

January 1, 2014

Enrollment Period

6.1 years

First QC Date

April 20, 2007

Last Update Submit

January 31, 2014

Conditions

Chronic Prostatitis With Chronic Pelvic Pain SyndromeProstatitis

Keywords

ProstatitisChronic Prostatitis with Chronic Pelvic Pain SyndromeBotulinum Toxin Type ADrug therapyInjections, intramuscular

Outcome Measures

Primary Outcomes (1)

  • NIH-CPSI Total Score

    1 year

Secondary Outcomes (3)

  • NIH-CPSI Subscales

    1 year

  • Standardized questions for the assessment of the treatment outcome

    1 year

  • International prostate symptom score (I-PSS)

    1 year

Study Arms (2)

1

EXPERIMENTAL

Botulinum Toxin Type A 200 U in 4ml NaCl 0.9%

Drug: Botulinum Toxin Type A

2

PLACEBO COMPARATOR

4ml NaCl 0.9%

Drug: Placebo

Interventions

Botulinum Toxin Type ADRUG

Single intrasphincteric injection at the 3,6,9, and 12 o'clock positions of the external urethral sphincter (1 ml of drug solution each)

Also known as: Botox
1
PlaceboDRUG

4ml NaCl 0.9%

2

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CPPS NIH III (symptoms over 3 months during the last 6 months, 4 glass-test)
  • Pain Score ≥ 4

You may not qualify if:

  • During the last month: intake of antibiotics, alpha receptor blockers, anticholinergics; intake of analgesics containing opioids (longer than 4 days); participating in a different clinical trial
  • During the last 3 months:documented urinary infection, epididymitis, positive urinary culture; status post biopsy of the prostate gland; STD: Gonorrhea, Chlamydia, Mycoplasm, Trichomonads
  • During the last 6 months: Finasteride or any other 5α-reductase inhibitor
  • During the last 12 months: status post any surgery on the prostate gland; genital herpes; not adjustable hypertension, angina pectoris, heart failure (NYHA III-IV), Status post myocardial infarction, coronary bypass surgery or coronary dilatation
  • During the last 24 months: cerebral insult, TIA; active disease of the liver
  • Other urological diseases like prostate cancer, bladder cancer, status post radiation of the small pelvis, chemotherapy (intravesical or systemic)
  • Urinary catheter
  • Residual urine \> 200ml
  • Serum creatinine \> 200µmol/l
  • Status post injection of BTX A, hypersensitivity concerning any substances of content of BTX, myasthenia gravis
  • Any kind of cancer
  • Active inflammation (except the prostate gland)
  • Neurological or psychological disease making signing of a consent form or behaving according to a study protocol impossible
  • Abuse of drugs or alcohol during last 5 years
  • Any disease that may influence the results according to the opinion of the medical doctor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, Cantonal Hospital of St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

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

Study Officials

  • Daniel S Engeler, MD

    Department of Urology, Cantonal Hospital of St. Gallen, St. Gallen, Switzerland

    PRINCIPAL INVESTIGATOR

  • Hans-Peter Schmid, MD

    Department of Urology, Cantonal Hospital of St. Gallen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

April 20, 2007

First Posted

April 23, 2007

Study Start

April 1, 2007

Primary Completion

May 1, 2013

Study Completion

June 1, 2013

Last Updated

February 3, 2014

Record last verified: 2014-01

Locations

CH(1)