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Botulinum Toxin Type A for the Treatment of Male Chronic Pelvic Pain Syndrome (BTX-URO-01)

Primary Purpose

Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Prostatitis

Status

Terminated

Phase

Phase 3

Locations

Switzerland

Study Type

Interventional

Intervention

Botulinum Toxin Type A

Placebo

About this trial

This is an interventional treatment trial for Chronic Prostatitis With Chronic Pelvic Pain Syndrome focused on measuring Prostatitis, Chronic Prostatitis with Chronic Pelvic Pain Syndrome, Botulinum Toxin Type A, Drug therapy, Injections, intramuscular

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Department of Urology, Cantonal Hospital of St. Gallen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

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

4ml NaCl 0.9%

Outcomes

Primary Outcome Measures

NIH-CPSI Total Score

Secondary Outcome Measures

NIH-CPSI Subscales

Standardized questions for the assessment of the treatment outcome

International prostate symptom score (I-PSS)

Full Information

NCT ID

NCT00464373

First Posted

April 20, 2007

Last Updated

January 31, 2014

Sponsor

Daniel Stephan Engeler

Collaborators

Allergan

1. Study Identification

Unique Protocol Identification Number

NCT00464373

Brief Title

Botulinum Toxin Type A for the Treatment of Male Chronic Pelvic Pain Syndrome

Acronym

BTX-URO-01

Official Title

Injection of Botulinum Toxin Type A Into the External Urethral Sphincter for Male Patients Suffering From Chronic Prostatitis/Chronic Pelvic Pain Syndrome (NIH Cat. III): a Prospective, Double-blind and Placebo-controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Terminated

Why Stopped

Slow accrual.

Study Start Date

April 2007 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Daniel Stephan Engeler

Collaborators

Allergan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The treatment of the male CP/CPPS is often as unsuccessful as frustrating for patients and doctors. Because of that patients change their general practitioners or urologists quite regularly. One of the major problems is the unknown pathomechanism of the disease. Most patients are suffering from irritative voiding symptoms and a dysfunction of the pelvic floor. By looking at the various (non-) conservative therapeutical strategies it becomes quite clear that there is no unique and convincing therapeutical strategy. At present Botulinum-Toxin Type A (BTX A) is widely used in the urological field especially for para-/tetraplegics patients having trouble with neurogenic bladder dysfunction. It has been reported in case series (doses: 200U and 30U) that BTX A injected into the external urethral sphincter is able to reduce the symptoms without provoking incontinence. This is implied with the hypothesis that obstructive voiding symptoms because of a CP/CPPS are associated with an incomplete relaxation of the bladder neck and the external urethral sphincter. After having given their informed consent, patients undergo a screening visit and baseline evaluation including patients history, clinical examination, NIH-CPSI and IPSS-questionnaires, micturition diary, sonography, 4-glass test and urodynamics. Patients fulfilling the study eligibility criteria are randomized to receive intrasphincteric injection of either BTX A or placebo. There will be 5 follow-up visits including a post-treatment follow-up after 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Prostatitis

Keywords

Prostatitis, Chronic Prostatitis with Chronic Pelvic Pain Syndrome, Botulinum Toxin Type A, Drug therapy, Injections, intramuscular

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Placebo Comparator

Arm Description

4ml NaCl 0.9%

Intervention Type

Drug

Intervention Name(s)

Botulinum Toxin Type A

Other Intervention Name(s)

Botox

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

4ml NaCl 0.9%

Primary Outcome Measure Information:

Title

NIH-CPSI Total Score

Time Frame

1 year

Secondary Outcome Measure Information:

Title

NIH-CPSI Subscales

Time Frame

1 year

Title

Standardized questions for the assessment of the treatment outcome

Time Frame

1 year

Title

International prostate symptom score (I-PSS)

Time Frame

1 year

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel S Engeler, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hans-Peter Schmid, MD

Organizational Affiliation

Department of Urology, Cantonal Hospital of St. Gallen

Official's Role

Study Director

Facility Information:

Facility Name

Department of Urology, Cantonal Hospital of St. Gallen

City

St. Gallen

ZIP/Postal Code

9007

Country

Switzerland

12. IPD Sharing Statement

Learn more about this trial

Botulinum Toxin Type A for the Treatment of Male Chronic Pelvic Pain Syndrome

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