Acupuncture for the Treatment of Interstitial Cystitis (IC) Symptoms

NCT00094874 | Unknown Phase 3

• 1 other identifier: 801685
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 if one type demonstrates improvement over the other. In the first type needles stimulate acupuncture points on the skin, and in the second type the needles penetrate through the skin similar to how acupuncture is usually performed. The technique is done through shields so that people will not know what type of acupuncture they receive. Patients must have at least moderately severe disease as determined by a urologist. They must be willing not to change their medical regimen for the duration of the trial. Patients will receive twelve treatments over six to twelve weeks. They will be asked to fill out symptom questionnaires and bladder diaries at regular intervals to monitor change. All treatment is free of charge, and patients who complete the trial will receive a small stipend.

Conditions

Interstitial Cystitis

Keywords

pelvic pain, bladder pain, urgency, frequency, nocturia

Outcome Measures

Primary Outcomes (1)

• Rate of improvement between arms as indicated by a Patient Overall Rating of Improvement Scale

Secondary Outcomes (3)

• Improvement in Interstitial Cystitis Symptom and Problem Indices (validated symptom-specific measures)

• Improvement in University of Wisconsin-Interstitial Cystitis Scale (validated symptom-specific measure)

• Improvement in frequency, urgency and nocturia as measured on bladder diaries

Interventions

Acupuncture PROCEDURE

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Mary Elizabeth Groff Surgical Medical Research and Education Charitable Trust: lead

Study Sites (1)

University of Pennsylvania Pain Medicine Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Cystitis, Interstitial; Pelvic Pain; Nocturia

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lower Urinary Tract Symptoms; Urological Manifestations

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 27, 2004
• First Posted: October 28, 2004
• Study Start: September 1, 2004
• Study Completion: September 1, 2005
• Last Updated: June 24, 2005

Record last verified: 2004-10

Locations

US (1)