Interstitial CystitisNCT03722992
The Effects of Mindfulness-based Stress Reduction in Interstitial Cystitis Patients
A study testing MBSR in people with Interstitial Cystitis, run by TriHealth Inc. at 1 site in United States.
Trial summary
This is a prospective cohort study to investigate differences in the bladder environment (i.e. urinary microbiome) amongst women with interstitial cystitis (IC) before and after undergoing mindfulness-based stress reduction (MBSR) treatment, including yoga and meditation practices. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Interstitial Cystitis
- What is being tested?
- MBSR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2019to 15 Mar 2020
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years of age or older
- English-speaking
- Established patient of Cincinnati Urogynecology Associates, TriHealth Inc.
- Current diagnosis of IC/PBS, as defined by the American Urological Association (AUA)
- Negative urinalysis or urine culture within 2 months of enrollment
- Currently undergoing first or second-line treatment for IC, as defined by the AUA
- Willingness to participate in study
Who cannot join
- Non-English speaking
- Unwillingness to participate in study
- Pregnancy or breastfeeding
- Physical or mental impairment that would affect the subject's ability to participate in the MBSR treatment, including patients with Dementia, Parkinsonism, or those who have impaired mobility or hearing
- Current or expected prolonged catheterization
- Expected travel or surgery that would hinder the ability to attend all eight MBSR sessions
- Undergoing third-, fourth-, fifth-, or sixth-line treatment for IC as defined by the AUA
- Subjects on antibiotics currently or prior use within one week of consenting
Trial locations and contacts
1 site in 1 country.
United States1 site
TriHealth - Cincinnati Urogynecology Associates
Cincinnati, Ohio, 45220
About this study
Official title: The Effects of Mindfulness-based Stress Reduction on the Urinary Microbiome in Patients With Interstitial Cystitis/Painful Bladder Syndrome
This is a prospective cohort study to investigate differences in the bladder environment (i.e. urinary microbiome) amongst women with interstitial cystitis (IC) before and after undergoing mindfulness-based stress reduction (MBSR) treatment, including yoga and meditation practices.
Read the detailed description
Interstitial cystitis (IC), or Painful Bladder Syndrome (PBS) is a debilitating condition of the bladder that is estimated to affect 3-8 million women in the United States. The pathophysiology of the disease is poorly understood, and thus treatment modalities and treatment efficacy vary widely. Lately, much attention has shifted toward investigating how the bladder 'environment' differs amongst women with IC compared to those who do not suffer from IC.
Mindfulness-based stress reduction (MBSR), a complementary alternative medicine (CAM)-based therapy, is a standardized program including components of meditation and yoga. Recent studies show that MBSR improves symptoms in the IC patient population.
The purpose of this study is to compare measurable differences in the urinary microbiome among women with IC before and after MBSR treatment.
- Conditions
- Interstitial Cystitis
- Being tested
- MBSR
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSROther
Guided yoga and meditation practices
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Cohort | Other | Mindfulness-based stress reduction (MBSR) treatment group Receives: Other: MBSR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the urinary microbiome before and after MBSR treatment
Urinary microbiome sequencing analysis will be performed by Resphera Biosciences Laboratory
Measured: Before intervention and after completion of the intervention, up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start7 Mar 2019
- Primary completion15 Jan 2020
- Study completion15 Mar 2020
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Pauls, MD, Principal investigator, TriHealth - Cincinnati Urogynecology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722992
- Sponsor's protocol ID
- 18-056
- Status last verified
- Nov 2019
- First submitted
- 24 Oct 2018
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mindfulness-based Stress Reduction on the Urinary Microbiome in Patients With Interstitial Cystitis/Painful Bladder Syndrome
- ClinicalTrials.gov ID
- NCT03722992
- Acronym / sponsor ID
- 18-056
- Conditions
- Interstitial Cystitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 29 Oct 2018 (actual)
- 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.
This is a prospective cohort study to investigate differences in the bladder environment (i.e. urinary microbiome) amongst women with interstitial cystitis (IC) before and after undergoing mindfulness-based stress reduction (MBSR) treatment, including yoga and meditation practices.
Detailed description
Interstitial cystitis (IC), or Painful Bladder Syndrome (PBS) is a debilitating condition of the bladder that is estimated to affect 3-8 million women in the United States. The pathophysiology of the disease is poorly understood, and thus treatment modalities and treatment efficacy vary widely. Lately, much attention has shifted toward investigating how the bladder 'environment' differs amongst women with IC compared to those who do not suffer from IC.
Mindfulness-based stress reduction (MBSR), a complementary alternative medicine (CAM)-based therapy, is a standardized program including components of meditation and yoga. Recent studies show that MBSR improves symptoms in the IC patient population.
The purpose of this study is to compare measurable differences in the urinary microbiome among women with IC before and after MBSR treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Cohort | Other | Other: MBSRMindfulness-based stress reduction (MBSR) treatment group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults 18 years of age or older
- English-speaking
- Established patient of Cincinnati Urogynecology Associates, TriHealth Inc.
- Current diagnosis of IC/PBS, as defined by the American Urological Association (AUA)
- Negative urinalysis or urine culture within 2 months of enrollment
Key exclusion criteria (8 listed)
- Non-English speaking
- Unwillingness to participate in study
- Pregnancy or breastfeeding
- Physical or mental impairment that would affect the subject's ability to participate in the MBSR treatment, including patients with Dementia, Parkinsonism, or those who have impaired mobility or hearing
- Current or expected prolonged catheterization
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 |
|---|---|---|
| MBSRGuided yoga and meditation practices | Other | Mindfulness Cohort |
Primary outcome
Difference in the urinary microbiome before and after MBSR treatment
Time frame: Before intervention and after completion of the intervention, up to 9 weeks
Urinary microbiome sequencing analysis will be performed by Resphera Biosciences Laboratory
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Individual participant dataSharing planned: No
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EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
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Investigation of PEMF Therapy for Female Patients With IC/BPS
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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.
Rachel Pauls, MD principal investigator
TriHealth - Cincinnati Urogynecology Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBSR in people with Interstitial Cystitis, run by TriHealth Inc. 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 8 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: finished, as of the sponsor's last update on 23 Jul 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Difference in the urinary microbiome before and after MBSR treatment (time frame: Before intervention and after completion of the intervention, up to 9 weeks). 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 23 Jul 2020.