TerminatedPhase 3

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

Stopped: Slow accrual.

Switzerland11 participantsStarted 2007-04

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 durin…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

NIH-CPSI Total Score

Timeframe: 1 year

Trial details

NCT IDNCT00464373

SponsorDaniel Stephan Engeler

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-05

View on ClinicalTrials.gov More Chronic Prostatitis With Chronic Pelvic Pain Syndrome trials