Status:
UNKNOWN
Acupuncture for the Treatment of Interstitial Cystitis (IC) Symptoms
Lead Sponsor:
The Mary Elizabeth Groff Surgical Medical Research and Education Charitable Trust
Conditions:
Interstitial Cystitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Acupuncture is a form of Chinese medicine that has been in existence for more than a thousand years. This clinical trial performs two types of acupuncture on traditional 'bladder' points to determine ...
Detailed Description
Patients eligible for enrollment include: * Age 18-65 years * Symptomatic IC for at least six months * Urinary frequency of at least eleven voids in a 24 hour period * A self-rated global discomfort ...
Eligibility Criteria
Inclusion
- Age 18-65 years
- Symptomatic IC for at least six months
- Urinary frequency of at least eleven voids in a 24 hour period
- A self-rated global discomfort score of 4 or greater on a 0-10 scale
Exclusion
- Medical History or Co-Morbid Conditions:
- Any history of: bladder calculus, tuberculous cystitis; neurological disease or diabetic cystopathy; malignant bladder tumors, urethral cancer
- Prior 3 years of uterine, cervical or vaginal cancer (women only)
- Prior 6-12 weeks of: bacterial urinary tract infection; active genital herpes; gross hematuria
- Concurrent active urethral calculus, ureteral calculus, symptomatic urethral diverticulum; documented chronic bacterial prostatitis (men only); active vaginitis, pregnancy (women only)
- Prior and Concurrent Treatment for IC:
- Any history of: cyclophosphamide, pelvic radiation; augmentation cystoplasty, cystectomy or cystolysis, neurectomy, implanted peripheral nerve stimulator; prostate surgery or treatment (men only)
- In the prior 24 weeks: any treatment with intravesical BCG, cystocele, rectocele, urinary incontinence surgery, transvaginal surgery, hysterectomy, prolapse, vaginal delivery or C-section (women only)
- Prior 6-12 weeks: any treatment by urethral dilatation, cystometrogram, urodynamics, cystoscopy/hydrodistention, bladder biopsy; prostate biopsy (men only); any intravesical treatment other than BCG
- Prior 4 weeks: any new medications initiated for IC
- Concurrent intravesical heparin, chronic use of acetylsalicylic acid, non-steroidal anti-inflammatory drugs or opioid pain medications for another pain condition
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00094874
Start Date
September 1 2004
End Date
September 1 2005
Last Update
June 24 2005
Active Locations (1)
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1
University of Pennsylvania Pain Medicine Center
Philadelphia, Pennsylvania, United States, 19104