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Acupuncture for the Treatment of Interstitial Cystitis (IC) Symptoms

Primary Purpose

Interstitial Cystitis

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
The Mary Elizabeth Groff Surgical Medical Research and Education Charitable Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis focused on measuring pelvic pain, bladder pain, urgency, frequency, nocturia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pennsylvania Pain Medicine CenterRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 27, 2004
Last Updated
June 23, 2005
Sponsor
The Mary Elizabeth Groff Surgical Medical Research and Education Charitable Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00094874
Brief Title
Acupuncture for the Treatment of Interstitial Cystitis (IC) Symptoms
Official Title
A Double-Blind, Randomized Study of Puncturing Versus Non-Puncturing Acupuncture for the Treatment of Interstitial Cystitis Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
October 2004
Overall Recruitment Status
Unknown status
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The Mary Elizabeth Groff Surgical Medical Research and Education Charitable Trust

4. Oversight

5. Study Description

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.
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 score of 4 or greater on a 0-10 scale Patients may not be enrolled who have a history of chronic bladder disease or pelvic disease including cancer, calculi, infection or complications of nervous system disease or diabetes. They must be on no blood thinning agents or have had any recent medication changes or bladder procedures. After screening physical examination and history-taking, patients will be asked to fill out standard symptom questionnaires. They will be given a bladder diary to fill out for the 24 hours prior to their first acupuncture treatment which will be scheduled within a week. Patients will be asked to return from once- to twice-weekly for a total of twelve treatments. Patients will complete a bladder diary before each treatment and a questionnaire form before every other visit. The same questionnaire will be used at the exit interview after the last treatment, and a final time four weeks after the last treatment. This is because we are interested in the duration of potential benefit from acupuncture treatment. Patients will be randomly assigned to one of two groups. All acupuncture will be performed through plastic shields so that the patient does not know which group he or she has been assigned to. In the first type of acupuncture, retractable needles are used such that the patient feels a pin sensation but there is no penetration of the epidermis. In the second type, non-retractable needles penetrate the acupuncture points into deeper tissue. It is not known whether deeper penetration is required for acupuncture to work, or if acupuncture is of benefit at all for this condition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis
Keywords
pelvic pain, bladder pain, urgency, frequency, nocturia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Primary Outcome Measure Information:
Title
Rate of improvement between arms as indicated by a Patient Overall Rating of Improvement Scale
Secondary Outcome Measure Information:
Title
Improvement in Interstitial Cystitis Symptom and Problem Indices (validated symptom-specific measures)
Title
Improvement in University of Wisconsin-Interstitial Cystitis Scale (validated symptom-specific measure)
Title
Improvement in frequency, urgency and nocturia as measured on bladder diaries

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Pennsylvania Pain Medicine Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin A Dolan, MD
Phone
215-662-8816
Email
kevin.dolan@uphs.upenn.edu
First Name & Middle Initial & Last Name & Degree
Dell R Burkey, MD
Phone
215.662.3633
Email
burkeydr@uphs.upenn.edu
First Name & Middle Initial & Last Name & Degree
Kevin A Dolan, MD
First Name & Middle Initial & Last Name & Degree
Dell R Burkey, MD

12. IPD Sharing Statement

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Acupuncture for the Treatment of Interstitial Cystitis (IC) Symptoms

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