N/A
N=97
Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation
Interstitial Cystitis
Bottom Line
View on ClinicalTrials.gov: NCT04820855 ↗Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Number of Participants Designated as "Treatment Responders" Based on Global Response Assessment (GRA) — 31; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Treatment (Behavioral); Usual Cares (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of New Mexico
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Designated as "Treatment Responders" Based on Global Response Assessment (GRA) |
31; 10 | — |
| SECONDARY O'Leary-Sant: Interstitial Cystitis Symptom Index |
-3.4; -1.5 | — |
| SECONDARY O'Leary-Sant: Interstitial Cystitis Problem Index |
-3.7; -1.9 | — |
| SECONDARY Pain VAS Score |
-1.7; -0.3 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale |
-1.6; -0.6 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) Depression Subscale |
-1.6; -0.7 | — |
| SECONDARY PROMIS Pain Interference Score |
-5.5; -3.1 | — |
| SECONDARY Pain Self-efficacy-2 Score |
1.5; 0.9 | — |
Summary
This study is examining impact of pain on daily life, the ability to function and treatments used for patients with interstitial cystitis/painful bladder syndrome before and after a program of mindfulness and yoga, in comparison to patients who are undergoing treatment with their providers.
Eligibility Criteria
Inclusion Criteria
- Female
- >=Age 18
- IC/BPS diagnosis
- English or Spanish reading/writing
- Own a Smartphone and able to watch online yoga tutorials
- Ability/willingness to participate in follow up questionnaires
- ICSI/ICPI >6 at baseline
- Physical exam in the past 2 years by urogynecology or gynecologist
Exclusion Criteria
- Pregnancy or lactating
- Inability to speak/write in English/Spanish
- Known history of recurrent UTI
- Urinary retention ( PVR>150 ml)
- History of augmentation cystoplasty or urinary diversion.
- History of chemotherapy/radiation or radiation induced cystitis
- Hunner's Ulcers demonstrated in last 6 months by cystoscopy
- Parkinsonism with neurogenic bladder
- Multiple Sclerosis with neurogenic bladder
- CVA with residual deficits
- Patients with severe mobility impairment and inability to perform yoga postures
- Patients who are hard of hearing or visually impaired
- Imprisoned patients
Data sourced from ClinicalTrials.gov (NCT04820855). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.