Botox as a Treatment for Chronic Male Pelvic Pain Syndrome

NCT00194623 | Terminated Phase 4

• 1 other identifier: 02-5458-A 04
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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 (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.

Conditions

Chronic Male Pelvic Pain Syndrome

Keywords

prostatitis

Outcome Measures

Primary Outcomes (1)

• NIH-CPSI -pain scores at 3 months post-treatment follow-up

  3 months post treatment

Secondary Outcomes (1)

• AUA score at 3 months post-treatment follow-up

  3 months post-treatment

Interventions

Botulinum Toxin A (Botox) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Washington: lead
• Paul G. Allen Family Foundation: collaborator

MeSH Terms

Conditions

Prostatitis

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Richard E Berger, MD

  Professor of Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: August 1, 2003
• Study Completion: August 1, 2007
• Last Updated: October 19, 2007

Record last verified: 2007-10