The Effects of Mindfulness-based Stress Reduction in Interstitial Cystitis Patients
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|ClinicalTrials.gov Identifier: NCT03722992|
Recruitment Status : Active, not recruiting
First Posted : October 29, 2018
Last Update Posted : May 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Interstitial Cystitis||Other: MBSR||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Mindfulness-based Stress Reduction on the Urinary Microbiome in Patients With Interstitial Cystitis/Painful Bladder Syndrome|
|Actual Study Start Date :||March 7, 2019|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Mindfulness-based stress reduction (MBSR) treatment group
Guided yoga and meditation practices
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03722992
|United States, Ohio|
|TriHealth - Cincinnati Urogynecology Associates|
|Cincinnati, Ohio, United States, 45220|
|Principal Investigator:||Rachel Pauls, MD||TriHealth - Cincinnati Urogynecology Associates|