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

Daniel Stephan Engeler

Status and phase

Terminated

Phase 3

Conditions

Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Prostatitis

Treatments

Drug: Botulinum Toxin Type A

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00464373

EKSG 06/056

BTX-URO-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 patients

Sex

Male

Ages

18 to 70 years old

Volunteers

No 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