Chronic Male Pelvic Pain SyndromePhase 4NCT00194623
Botox as a Treatment for Chronic Male Pelvic Pain Syndrome
A Phase 4 study testing Botulinum Toxin A (Botox) in people with Chronic Male Pelvic Pain Syndrome, run by University of Washington.
Trial summary
Chronic pelvic pain syndrome (CPPS) is thought to affect approximately 8% of men aged 18 and older. Patients with this condition experience pain in the perineum, the genitalia, and the rectum. As well, there is associated voiding, sexual, and ejaculatory dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Chronic Male Pelvic Pain Syndrome
- What is being tested?
- Botulinum Toxin A (Botox)
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2003to Aug 2007
- Phase
- Phase 4
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged 18 and older
- History of chronic pelvic pain syndrome (NIH type IIIA and IIIB) for at least 3 months
- No antibiotics or new treatment for prostatitis for at least 30 days
- Written informed consent and written authorization for use or release of health and research study information have been obtained.
- Subject has severity/stage of disease: pain areas must include perineum.
- Laboratory findings required : negative urine cultures.
- Ability to follow study instructions and likely to complete all required visits.
Who cannot join
- Documented urinary tract infection
- Bacteria isolated to the prostate from segmental urine cultures
- Pain from another source in the genitourinary tract (e.g. renal colic)
- Genitourinary (GU) malignancy
- History of radiation to the GU tract
- Previous or current botulinum therapy
Show all 19Show fewer
- Known allergy or sensitivity to any study medication (Botox, lidocaine)
- Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis, spinal cord injury or any other significant disease which might interfere with neuromuscular transmission
- Concurrent use of aminoglycoside antibiotics or agents that interfere with neuromuscular transmission
- Profound atrophy or excessive weakness of the muscles to be injected
- Infection at the injection site or systemic infection
- Concurrent participation in another investigational drug study
- Is overtly psychotic or suicidal.
- Has post-surgical pain
- Has back or rectal pain only.
- Was treated for prostate, bladder, renal or other genitourinary malignancy
- Had in the past or is currently undergoing radiation therapy
- Has a history of genitourinary tuberculosis
- Is currently taking antibiotics.
About this study
Official title: Botox (Botulinum Toxin A) as a Treatment for Chronic Male Pelvic Pain Syndrome: A Randomized Placebo Controlled Trial
Chronic pelvic pain syndrome (CPPS) is thought to affect approximately 8% of men aged 18 and older. Patients with this condition experience pain in the perineum, the genitalia, and the rectum. As well, there is associated voiding, sexual, and ejaculatory dysfunction. The impact of patient well-being is thought to be equivalent to patients with congestive heart failure. The etiology of this condition is unknown, thus making treatment very difficult. Researchers have pursued an infectious cause for the disease; however, studies have failed to substantiate this theory. Despite this, the main treatment offered to patients is long-term antibiotic therapy. Results from this treatment modality have been unsatisfactory.
Other groups have postulated that the symptoms of CPPS may be secondary to neuromuscular factors. Some studies have demonstrated increases in pelvic muscular tone. Maneuvers such as prostate massage and levator massage have shown some benefit in relieving symptoms. Treatment with alpha-blockers to relax prostate smooth muscle has brought about improvement in a portion of patients. Use of generalized muscle relaxants has produced mediocre results.
Read more
However, many of these neuromuscular treatments are generalized and do not target the perineal musculature directly. It is theorized that spasm of the perineal muscles triggered by an unknown noxious stimuli (e.g. infection) cause the pain and symptoms of CPPS. At our center, we have performed pilot studies using botulinum toxin A. Four patients were treated with Botox". 100 U were injected in three locations in the midline of the bulbocavernosus muscle. The bulbocavernosus muscle is easily accessible and shares innervation with the pelvic musculature. Patient's response to medication was measured by the NIH Prostatitis pain scale and as well as the University of Washington prostatitis pain scale. All patients reported resolution of symptoms. Remission lasted for duration of 10-12 weeks. No patients reported adverse events.
HYPOTHESIS
Botulinum toxin A is effective in the treatment of chronic pelvic pain syndrome in men.
Read the detailed description
Visit 1 Patient will review and sign the study consent form. Subject will be asked to complete questionnaires. Then, patient will then be asked to give a semen sample.
Visit 2 (1 week after Visit I) Prior to this visit, the patient will be randomized to either active medication or placebo. First, the patient will then undergo a physical exam including a genital and rectal exam. Then, the patient will be brought in to the room and placed in lithotomy position. The perineum will be prepped with iodine solution. EMG electrodes and a ground will be placed in the perineum. Three landmarks (1. middle of bulbospongiosus muscle; 2. perineal body; 3. an area equidistant from 1 and 2) will be marked using a skin marker. The EMG needle will be placed into each landmark and the patient will be asked to squeeze his perineal muscles. Once in the proper location, 1.3 cc of medication (active drug or placebo) will be distributed into these landmarks. The remaining 2.6 ccs will be injected into 2 other painful pelvic muscle sites as determined physical exam. The area will then be gently massaged.
- Month Post Injection Mailing: The patient will be mailed a packet containing follow-up questionnaires.
- Month Post Injection Mailing: Same as 1 Month Post Injection Visit.
- Month Post Visit (Visit 3) First, the subject will be asked to fill out follow-up questionnaires. Next, a physical exam and prostate massage will be performed and expressed prostatic secretions collected. Finally, the subject will be asked to provide a semen sample.
Optional open label trial for those patients randomized to placebo section:
Open label injection visit (Visit 4) Injection of open label Botox as in Visit 2.
- Month Post Open Label Botox Injection Mailing: The patient will be mailed a packet containing follow-up questionnaires.
- Month Post Open Label Botox Injection Mailing: Same as 1 Month Post Injection mailing.
- Month Post Open Label Injection Visit:
Same as Visit 3.
- Conditions
- Chronic Male Pelvic Pain Syndrome
- Being tested
- Botulinum Toxin A (Botox)
- Keywords
- prostatitis
- 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 A (Botox)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
NIH-CPSI -pain scores at 3 months post-treatment follow-up
Measured: 3 months post treatment
Secondary outcomes (1)
AUA score at 3 months post-treatment follow-up
Measured: 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startAug 2003
- Study completionAug 2007
Why it stopped: Reorganization of personnel forced termination.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Male Pelvic Pain SyndromeStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Paul G. Allen Family Foundation
- Investigators
- Richard E Berger, MD, Principal investigator, Professor of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194623
- Sponsor's protocol ID
- 02-5458-A 04
- Status last verified
- Oct 2007
- First submitted
- 13 Sep 2005
- Last updated
- 19 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botox (Botulinum Toxin A) as a Treatment for Chronic Male Pelvic Pain Syndrome: A Randomized Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT00194623
- Acronym / sponsor ID
- 02-5458-A 04
- Conditions
- Chronic Male Pelvic Pain Syndrome
- Keywords
- prostatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Reorganization of personnel forced termination.
- Enrolment
- 30 participants
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Paul G. Allen Family Foundation
- Study start
- Aug 2003
- Study completion
- Aug 2007
- First posted
- 19 Sep 2005 (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.
Chronic pelvic pain syndrome (CPPS) is thought to affect approximately 8% of men aged 18 and older. Patients with this condition experience pain in the perineum, the genitalia, and the rectum. As well, there is associated voiding, sexual, and ejaculatory dysfunction. The impact of patient well-being is thought to be equivalent to patients with congestive heart failure. The etiology of this condition is unknown, thus making treatment very difficult. Researchers have pursued an infectious cause for the disease; however, studies have failed to substantiate this theory. Despite this, the main treatment offered to patients is long-term antibiotic therapy. Results from this treatment modality have been unsatisfactory.
Other groups have postulated that the symptoms of CPPS may be secondary to neuromuscular factors. Some studies have demonstrated increases in pelvic muscular tone. Maneuvers such as prostate massage and levator massage have shown some benefit in relieving symptoms. Treatment with alpha-blockers to relax prostate smooth muscle has brought about improvement in a portion of patients. Use of generalized muscle relaxants has produced mediocre results.
However, many of these neuromuscular treatments are generalized and do not target the perineal musculature directly. It is theorized that spasm of the perineal muscles triggered by an unknown noxious stimuli (e.g. infection) cause the pain and symptoms of CPPS. At our center, we have performed pilot studies using botulinum toxin A. Four patients were treated with Botox". 100 U were injected in three locations in the midline of the bulbocavernosus muscle. The bulbocavernosus muscle is easily accessible and shares innervation with the pelvic musculature. Patient's response to medication was measured by the NIH Prostatitis pain scale and as well as the University of Washington prostatitis pain scale. All patients reported resolution of symptoms. Remission lasted for duration of 10-12 weeks. No patients reported adverse events.
HYPOTHESIS
Botulinum toxin A is effective in the treatment of chronic pelvic pain syndrome in men.
Detailed description
Visit 1 Patient will review and sign the study consent form. Subject will be asked to complete questionnaires. Then, patient will then be asked to give a semen sample.
Visit 2 (1 week after Visit I) Prior to this visit, the patient will be randomized to either active medication or placebo. First, the patient will then undergo a physical exam including a genital and rectal exam. Then, the patient will be brought in to the room and placed in lithotomy position. The perineum will be prepped with iodine solution. EMG electrodes and a ground will be placed in the perineum. Three landmarks (1. middle of bulbospongiosus muscle; 2. perineal body; 3. an area equidistant from 1 and 2) will be marked using a skin marker. The EMG needle will be placed into each landmark and the patient will be asked to squeeze his perineal muscles. Once in the proper location, 1.3 cc of medication (active drug or placebo) will be distributed into these landmarks. The remaining 2.6 ccs will be injected into 2 other painful pelvic muscle sites as determined physical exam. The area will then be gently massaged.
- Month Post Injection Mailing: The patient will be mailed a packet containing follow-up questionnaires.
- Month Post Injection Mailing: Same as 1 Month Post Injection Visit.
- Month Post Visit (Visit 3) First, the subject will be asked to fill out follow-up questionnaires. Next, a physical exam and prostate massage will be performed and expressed prostatic secretions collected. Finally, the subject will be asked to provide a semen sample.
Optional open label trial for those patients randomized to placebo section:
Open label injection visit (Visit 4) Injection of open label Botox as in Visit 2.
- Month Post Open Label Botox Injection Mailing: The patient will be mailed a packet containing follow-up questionnaires.
- Month Post Open Label Botox Injection Mailing: Same as 1 Month Post Injection mailing.
- Month Post Open Label Injection Visit:
Same as Visit 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men aged 18 and older
- History of chronic pelvic pain syndrome (NIH type IIIA and IIIB) for at least 3 months
- No antibiotics or new treatment for prostatitis for at least 30 days
- Written informed consent and written authorization for use or release of health and research study information have been obtained.
- Subject has severity/stage of disease: pain areas must include perineum.
Key exclusion criteria (19 listed)
- Documented urinary tract infection
- Bacteria isolated to the prostate from segmental urine cultures
- Pain from another source in the genitourinary tract (e.g. renal colic)
- Genitourinary (GU) malignancy
- History of radiation to the GU tract
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 A (Botox) | Drug | – |
Primary outcome
NIH-CPSI -pain scores at 3 months post-treatment follow-up
Time frame: 3 months post treatment
1 secondary outcome
AUA score at 3 months post-treatment follow-up
Time frame: 3 months post-treatment
Results and safety
The study was stopped early (reason given: Reorganization of personnel forced termination.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2007.
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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.
Richard E Berger, MD principal investigator
Professor of Urology
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum Toxin A (Botox) in people with Chronic Male Pelvic Pain Syndrome, run by University of Washington.
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 7 inclusion and 19 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 19 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: Reorganization of personnel forced termination.). 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 -pain scores at 3 months post-treatment follow-up (time frame: 3 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2007.