Recruiting
Phase 3

Acupuncture

Sponsor:

The Mary Elizabeth Groff Surgical Medical Research and Education Charitable Trust

Code:

NCT00094874

Conditions

Interstitial Cystitis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Acupuncture

Study Details

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

Study ID

NCT00094874

Start date

Sep, 2004

Status verified date

Oct, 2004

Completion date

Sep, 2005

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

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

Study Design

Enrollment

60 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Acupuncture

Primary outcome measure

  • Rate of improvement between arms as indicated by a Patient Overall Rating of Improvement Scale [ Time Frame: undefined ]

Central Contacts and Locations

Locations

University of Pennsylvania Pain Medicine Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Kevin A Dolan, MD

215-662-8816kevin.dolan@uphs.upenn.edu

Dell R Burkey, MD

215.662.3633burkeydr@uphs.upenn.edu

Principal Investigator:

Dell R Burkey, MD

More Information

Sponsor

The Mary Elizabeth Groff Surgical Medical Research and Education Charitable Trust

Last update posted

Jun 24, 2005

Last verified

Oct, 2004

Keywords

  • pelvic pain, bladder pain, urgency, frequency, nocturia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by The Mary Elizabeth Groff Surgical Medical Research and Education Charitable Trust on 2005-06-24.