Cystitis, InterstitialNCT00661050
Treatment of Interstitial Cystitis/Painful Bladder Syndrome Using Alternative Techniques: Exercise, Meditation, Tai Chi
An observational study of Cystitis, Interstitial, run by Stanford University at 1 site in United States.
Trial summary
Complementary and alternative medicine (CAM) is the term for medical products and/or practices that are not part of the current standard of care. Standard care is what medical doctors, doctors of osteopathy and allied health professionals, such as registered nurses and physical therapists, practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystitis, Interstitial
- What is being tested?
- Alternative Medicine and Tai Chi instruction and class participation or walking exercise and sitting meditation
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Dec 2008
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: IC Patients from Stanford University Urology Clinic's patient population.
Who may be able to join
- Participant has signed and dated the appropriate Informed Consent document.
- Participant is equal or > 18 years old
- Participant has a clinical diagnosis of IC/PBS and or CP/CPPS in the opinion of the investigator
- Participant with IC/PBS has reported a bladder pain or discomfort symptom score of 3 or greater on a 0-10 Likert scale over the previous four weeks. This bladder pain/discomfort criterion must be met at each of the two baseline screening visits as reported by the participant.
- Participant with IC/PBS has reported a symptom score of abnormal urinary frequency of 3 or greater on 0-10 Likert scale over the previous four weeks. This frequency criterion must be met at least each of the two baseline screening visits.
- Participant has had symptoms of discomfort or pain in the pelvic region for at least a three (3) month period within the last six (6) months.
- Participant has previously undergone at least one course of other form of standard therapy for his/her symptoms Exclusion Criteria:1. Participant can not stand in place for at least 15 minutes.
Who cannot join
- Participants have severe lower extremity disease that would prohibit participation in walking or Tai Chi movements.
- Participant cannot hold urine for at least 30 minutes
- Participant has relevant neurologic disorder that affects bladder and/or neuromuscular function in the opinion of the investigator.
- Participant has active urethral or ureteral calculi, urethral diverticulum.
- Participant has a history of pelvic radiation therapy, tuberculous cystitis, bladder cancer, carcinoma in situ, prostate cancer, or urethral cancer.
- Participant has/reports any severe debilitating or urgent concurrent medical condition.
- Participant has a potentially significant pelvic pathology or abnormalities on examination or prior imaging, including prolapse beyond the hymenal ring, pelvic mass, etc. that could cause or contribute to the clinical symptoms or require treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Exercise and Meditation: A Pilot Study of Alternative Techniques in the Treatment of Chronic Pelvic Pain Related to Painful Bladder Syndrome (PBS)/Interstitial Cystitis (IC) PI: Dr. Christopher Payne
Complementary and alternative medicine (CAM) is the term for medical products and/or practices that are not part of the current standard of care. Standard care is what medical doctors, doctors of osteopathy and allied health professionals, such as registered nurses and physical therapists, practice. Alternative medicine means treatments that you use instead of standard ones. Complementary medicine means nonstandard treatments that you use along with standard ones. The purpose of this study is to determine whether there is any improvement in symptoms reported by patients with chronic painful bladder syndrome when participating in alternative medical therapy/ exercise and meditative techniques. The specific alternative techniques participants will be randomized to in this trial include: Tai Chi instruction or walking exercise combined with sitting meditation.
Read the detailed description
Participants will be referred for trial screening if they have a diagnosis of painful bladder syndrome/IC in the opinion of the investigator. Participants will be required to read the informed consent form and sign it prior to the screening of any medical information. The eligibility criteria will be reviewed and participants who qualify will complete the visit one study screening procedures. Participants will be asked to track there daily pain level and medication use for 7 days prior to randomization an in addition will be required to complete one 24-hour void diary during this same screening time period. Participants will be asked to give a urine sample on the day of screening and the day of randomization to screen for bladder infection. Female participants will be asked to provide a urine sample for pregnancy testing prior to randomization.
Participants will be required to be on a stable medical regime for 30 days prior to randomization. No new IC therapy or new pain treatments will be allowed to begin during the screening period and/or the 3 month study trial period. Participants will be allowed to continue on any IC/pain therapy they have used prior to screening.
Randomization to the treatment groups will occur 5-7 days prior to treatment start date. At that visit the patient#s medical history will be reviewed for eligibility and adverse events. The recorded pain scores collected and all quality of life measurements obtained. Participants who continue to qualify will be randomized to the specified treatment group.
Once 12 participants have been screened and are ready for randomization the participants will be scheduled for the randomization visit--Participants assigned to the Tai Chi group will be instructed on the logistics of the class, participants in this group will attend two classes/week- each class will be 1.5 hours in duration. The first 30 minutes will consist of standing meditation and progressive relaxation, the remaining 60 minutes will be TaiChi form instruction. The classes will meet bi-weekly for 3 months.
Participants will be contacted by the blinded coordinator at 2 week intervals to assess pain level, medication use, and adverse event monitoring, all data will be documented.
The exercise/meditation group will receive guided imagery CD and a pedometer to record the distance walked/bimonthly assessment. Participants will be asked to reserve 90 minutes twice weekly to complete the 30 min of walking exercise followed immediately by the 60 min of relaxation/mediation using the CD provided to them by the study. Participants will be asked to complete the exercise on the same days and times each week. The study coordinator will contact the participants every 2 weeks to assess pain level, medication use, and monitor for adverse events.
Participants will not be responsible for the costs of the Tai Chi classes, pedometer, and relaxation-guided imagery CD. Participants will be required to provide the CD player; patients will not be eligible if they do not have access to one. Participants will not be reimbursed for travel costs to the Tai Chi classes. Participants will be seen in clinic for the end-point evaluation 3-7 days after 3 month treatment period.
- Conditions
- Cystitis, Interstitial
- Being tested
- Alternative Medicine, Tai Chi instruction and class participation or walking exercise and sitting meditation
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternative MedicineProcedure or surgery
Tai Chi instruction and class participation or walking exercise and sitting meditationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Terminated due to low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystitis, InterstitialStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chris Payne, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661050
- Sponsor's protocol ID
- SU-03132008-1041
- Other IDs
- 11838
- Status last verified
- Mar 2011
- First submitted
- 4 Apr 2008
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Meditation: A Pilot Study of Alternative Techniques in the Treatment of Chronic Pelvic Pain Related to Painful Bladder Syndrome (PBS)/Interstitial Cystitis (IC) PI: Dr. Christopher Payne
- ClinicalTrials.gov ID
- NCT00661050
- Acronym / sponsor ID
- SU-03132008-1041
- Conditions
- Cystitis, Interstitial
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Terminated due to low enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 18 Apr 2008 (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.
Complementary and alternative medicine (CAM) is the term for medical products and/or practices that are not part of the current standard of care. Standard care is what medical doctors, doctors of osteopathy and allied health professionals, such as registered nurses and physical therapists, practice. Alternative medicine means treatments that you use instead of standard ones. Complementary medicine means nonstandard treatments that you use along with standard ones. The purpose of this study is to determine whether there is any improvement in symptoms reported by patients with chronic painful bladder syndrome when participating in alternative medical therapy/ exercise and meditative techniques. The specific alternative techniques participants will be randomized to in this trial include: Tai Chi instruction or walking exercise combined with sitting meditation.
Detailed description
Participants will be referred for trial screening if they have a diagnosis of painful bladder syndrome/IC in the opinion of the investigator. Participants will be required to read the informed consent form and sign it prior to the screening of any medical information. The eligibility criteria will be reviewed and participants who qualify will complete the visit one study screening procedures. Participants will be asked to track there daily pain level and medication use for 7 days prior to randomization an in addition will be required to complete one 24-hour void diary during this same screening time period. Participants will be asked to give a urine sample on the day of screening and the day of randomization to screen for bladder infection. Female participants will be asked to provide a urine sample for pregnancy testing prior to randomization.
Participants will be required to be on a stable medical regime for 30 days prior to randomization. No new IC therapy or new pain treatments will be allowed to begin during the screening period and/or the 3 month study trial period. Participants will be allowed to continue on any IC/pain therapy they have used prior to screening.
Randomization to the treatment groups will occur 5-7 days prior to treatment start date. At that visit the patient#s medical history will be reviewed for eligibility and adverse events. The recorded pain scores collected and all quality of life measurements obtained. Participants who continue to qualify will be randomized to the specified treatment group.
Once 12 participants have been screened and are ready for randomization the participants will be scheduled for the randomization visit--Participants assigned to the Tai Chi group will be instructed on the logistics of the class, participants in this group will attend two classes/week- each class will be 1.5 hours in duration. The first 30 minutes will consist of standing meditation and progressive relaxation, the remaining 60 minutes will be TaiChi form instruction. The classes will meet bi-weekly for 3 months.
Participants will be contacted by the blinded coordinator at 2 week intervals to assess pain level, medication use, and adverse event monitoring, all data will be documented.
The exercise/meditation group will receive guided imagery CD and a pedometer to record the distance walked/bimonthly assessment. Participants will be asked to reserve 90 minutes twice weekly to complete the 30 min of walking exercise followed immediately by the 60 min of relaxation/mediation using the CD provided to them by the study. Participants will be asked to complete the exercise on the same days and times each week. The study coordinator will contact the participants every 2 weeks to assess pain level, medication use, and monitor for adverse events.
Participants will not be responsible for the costs of the Tai Chi classes, pedometer, and relaxation-guided imagery CD. Participants will be required to provide the CD player; patients will not be eligible if they do not have access to one. Participants will not be reimbursed for travel costs to the Tai Chi classes. Participants will be seen in clinic for the end-point evaluation 3-7 days after 3 month treatment period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- IC Patients from Stanford University Urology Clinic's patient population.
Key inclusion criteria (7 listed)
- Participant has signed and dated the appropriate Informed Consent document.
- Participant is equal or > 18 years old
- Participant has a clinical diagnosis of IC/PBS and or CP/CPPS in the opinion of the investigator
- Participant with IC/PBS has reported a bladder pain or discomfort symptom score of 3 or greater on a 0-10 Likert scale over the previous four weeks. This bladder pain/discomfort criterion must be met at each of the two baseline screening visits as reported by the participant.
- Participant with IC/PBS has reported a symptom score of abnormal urinary frequency of 3 or greater on 0-10 Likert scale over the previous four weeks. This frequency criterion must be met at least each of the two baseline screening visits.
Key exclusion criteria (7 listed)
- Participants have severe lower extremity disease that would prohibit participation in walking or Tai Chi movements.
- Participant cannot hold urine for at least 30 minutes
- Participant has relevant neurologic disorder that affects bladder and/or neuromuscular function in the opinion of the investigator.
- Participant has active urethral or ureteral calculi, urethral diverticulum.
- Participant has a history of pelvic radiation therapy, tuberculous cystitis, bladder cancer, carcinoma in situ, prostate cancer, or urethral cancer.
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 |
|---|---|---|
| Alternative Medicine | Procedure or surgery | – |
| Tai Chi instruction and class participation or walking exercise and sitting meditation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
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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.
Chris Payne principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystitis, Interstitial, run by Stanford University 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 7 inclusion and 7 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: withdrawn, as of the sponsor's last update on 12 Apr 2024. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 12 Apr 2024.