Interstitial CystitisPhase 3NCT00094874
Acupuncture for the Treatment of Interstitial Cystitis (IC) Symptoms
A Phase 3 study testing Acupuncture in people with Interstitial Cystitis, run by The Mary Elizabeth Groff Surgical Medical Research and Education Charitable Trust at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Interstitial Cystitis
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Sep 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania Pain Medicine Center
Philadelphia, Pennsylvania, 19104
Kevin A Dolan, MD, 215-662-8816, kevin.dolan@uphs.upenn.edu
Dell R Burkey, MD, 215.662.3633, burkeydr@uphs.upenn.edu
About this study
Official title: A Double-Blind, Randomized Study of Puncturing Versus Non-Puncturing Acupuncture for the Treatment of Interstitial Cystitis Symptoms
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.
Read the 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.
- Conditions
- Interstitial Cystitis
- Being tested
- Acupuncture
- Keywords
- pelvic pain, bladder pain, urgency, frequency, nocturia
- Medical subject headings
- Cystitis, Interstitial, Pelvic Pain, Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2004 (estimated)
- Study startSep 2004
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- The Mary Elizabeth Groff Surgical Medical Research and Education Charitable Trust
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00094874
- Sponsor's protocol ID
- 801685
- Status last verified
- Oct 2004
- First submitted
- 27 Oct 2004
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized Study of Puncturing Versus Non-Puncturing Acupuncture for the Treatment of Interstitial Cystitis Symptoms
- ClinicalTrials.gov ID
- NCT00094874
- Acronym / sponsor ID
- 801685
- Conditions
- Interstitial Cystitis
- Keywords
- pelvic pain, bladder pain, urgency, frequency, nocturia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- The Mary Elizabeth Groff Surgical Medical Research and Education Charitable TrustUniversity, hospital or other
- Study start
- Sep 2004
- Study completion
- Sep 2005
- First posted
- 28 Oct 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
- Any history of: cyclophosphamide, pelvic radiation; augmentation cystoplasty, cystectomy or cystolysis, neurectomy, implanted peripheral nerve stimulator; prostate surgery or treatment (men only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture | Procedure or surgery | – |
Primary outcome
Rate of improvement between arms as indicated by a Patient Overall Rating of Improvement Scale
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
University of Pennsylvania Pain Medicine Center
Philadelphia, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acupuncture in people with Interstitial Cystitis, run by The Mary Elizabeth Groff Surgical Medical Research and Education Charitable Trust at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of improvement between arms as indicated by a Patient Overall Rating of Improvement Scale. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.