Chronic Prostatitis With Chronic Pelvic Pain SyndromePhase 3BTX-URO-01NCT00464373

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

A Phase 3 study testing Botulinum Toxin Type A in people with Chronic Prostatitis With Chronic Pelvic Pain Syndrome and Prostatitis, run by Daniel Stephan Engeler at 1 site in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years, men only
Conditions the study is for: Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Prostatitis
What is being tested?: Botulinum Toxin Type A
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 11 participants
Where: 1 siteSwitzerland
Study dates: Apr 2007to Jun 2013
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Show all 15Show fewer

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

Department of Urology, Cantonal Hospital of St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007

Other trials in Switzerland

About this study

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

Read the 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.

Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Prostatitis
Being tested: Botulinum Toxin Type A, Placebo
Keywords: Prostatitis, Chronic Prostatitis with Chronic Pelvic Pain Syndrome, Botulinum Toxin Type A, Drug therapy, Injections, intramuscular
Medical subject headings: Prostatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Botulinum Toxin Type ADrug
Also called Botox
Single intrasphincteric injection at the 3,6,9, and 12 o'clock positions of the external urethral sphincter (1 ml of drug solution each)
PlaceboDrug
4ml NaCl 0.9%

Study groups in NCT00464373
Study group	Role	What they receive
1	Experimental	Botulinum Toxin Type A 200 U in 4ml NaCl 0.9% Receives: Drug: Botulinum Toxin Type A
2	Placebo comparator	4ml NaCl 0.9% Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

NIH-CPSI Total Score
Measured: 1 year

Secondary outcomes (3)

NIH-CPSI Subscales
Measured: 1 year
Standardized questions for the assessment of the treatment outcome
Measured: 1 year
International prostate symptom score (I-PSS)
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2007Jun 2013

First posted23 Apr 2007 (estimated)
Study startApr 2007
Primary completionMay 2013
Study completionJun 2013

Why it stopped: Slow accrual.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Prostatitis With Chronic Pelvic Pain SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00464373
Sponsor's protocol ID: BTX-URO-01
Other IDs: EKSG 06/056
Acronym: BTX-URO-01
Status last verified: Jan 2014
First submitted: 20 Apr 2007
Last updated: 3 Feb 2014
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
Erectile Dysfunction Due to Arterial Insufficiency, Erectile Dysfunction
Recruiting
Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment
Chronic Interstitial Cystitis, Bladder Pain Syndrome
Not yet recruiting
Acupuncture for Erectile Dysfunction
Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), Erectile Dysfunctions
Not yet recruiting
TECAR Therapy on Pain and Quality of Life in Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Prostatitis
Recruiting
TaVNS Improves the Symptoms of Patients With Moderate to Severe CP/CPPS
Chronic Prostatitis

All Chronic Prostatitis With Chronic Pelvic Pain Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00464373
Acronym / sponsor ID: BTX-URO-01 / BTX-URO-01
Conditions: 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
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow accrual.
Enrolment: 11 participants (actual)
Lead sponsor: Daniel Stephan EngelerUniversity, hospital or other
Collaborators: Allergan
Study start: Apr 2007
Primary completion: May 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 23 Apr 2007 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Botulinum Toxin Type ABotulinum Toxin Type A 200 U in 4ml NaCl 0.9%
2	Placebo comparator	Drug: Placebo4ml NaCl 0.9%

Who may qualify

Ages: 18 to 70 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Botulinum Toxin Type AAlso: BotoxSingle intrasphincteric injection at the 3,6,9, and 12 o'clock positions of the external urethral sphincter (1 ml of drug solution each)	Drug	1
Placebo4ml NaCl 0.9%	Drug	2

Primary outcome

NIH-CPSI Total Score
Time frame: 1 year

3 secondary outcomes

NIH-CPSI Subscales
Time frame: 1 year
Standardized questions for the assessment of the treatment outcome
Time frame: 1 year
International prostate symptom score (I-PSS)
Time frame: 1 year

Results and safety

The study was stopped early (reason given: Slow accrual.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2014.

Related trials for Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Recruiting
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
Erectile Dysfunction Due to Arterial Insufficiency, Erectile Dysfunction
Recruiting
Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment
Chronic Interstitial Cystitis, Bladder Pain Syndrome
Not yet recruiting
Acupuncture for Erectile Dysfunction
Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), Erectile Dysfunctions
Not yet recruiting
TECAR Therapy on Pain and Quality of Life in Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Prostatitis
Recruiting
TaVNS Improves the Symptoms of Patients With Moderate to Severe CP/CPPS
Chronic Prostatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel S Engeler, MD principal investigator

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

Hans-Peter Schmid, MD study director

Department of Urology, Cantonal Hospital of St. Gallen

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Botulinum Toxin Type A in people with Chronic Prostatitis With Chronic Pelvic Pain Syndrome and Prostatitis, run by Daniel Stephan Engeler at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Slow accrual.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NIH-CPSI Total Score (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00464373.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2014.