Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194623
Status:
TERMINATED
Last Update Posted:
2007-10-19
First Post:
2005-09-13
Brief Title:
Botox as a Treatment for Chronic Male Pelvic Pain Syndrome
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Botox Botulinum Toxin A as a Treatment for Chronic Male Pelvic Pain Syndrome A Randomized Placebo Controlled Trial
Status:
TERMINATED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Reorganization of personnel forced termination
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 eg 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 Patients 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
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 eg 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 Patients 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 13 cc of medication active drug or placebo will be distributed into these landmarks The remaining 26 ccs will be injected into 2 other painful pelvic muscle sites as determined physical exam The area will then be gently massaged
1 Month Post Injection Mailing
The patient will be mailed a packet containing follow-up questionnaires
2 Month Post Injection Mailing Same as 1 Month Post Injection Visit
3 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
1 Month Post Open Label Botox Injection Mailing
The patient will be mailed a packet containing follow-up questionnaires
2 Month Post Open Label Botox Injection Mailing
Same as 1 Month Post Injection mailing
3 Month Post Open Label Injection Visit
Same as Visit 3
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 13 cc of medication active drug or placebo will be distributed into these landmarks The remaining 26 ccs will be injected into 2 other painful pelvic muscle sites as determined physical exam The area will then be gently massaged
1 Month Post Injection Mailing
The patient will be mailed a packet containing follow-up questionnaires
2 Month Post Injection Mailing Same as 1 Month Post Injection Visit
3 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
1 Month Post Open Label Botox Injection Mailing
The patient will be mailed a packet containing follow-up questionnaires
2 Month Post Open Label Botox Injection Mailing
Same as 1 Month Post Injection mailing
3 Month Post Open Label Injection Visit
Same as Visit 3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None