Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-18

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effects of Mindfulness-based Stress Reduction in Interstitial Cystitis Patients

NCT03722992

Interstitial Cystitis

COMPLETED NA

Mindfulness-Based Therapy for Interstitial Cystitis/Bladder Pain Syndrome

NCT02457182

Interstitial Cystitis Mindfulness Complementary Medicine +1 more

COMPLETED NA

Hypnosis for Bladder Pain Syndrome

NCT04010513

Bladder Pain Syndrome Interstitial Cystitis

COMPLETED NA

Biopsychosocial and Conventional Approach in Bladder Pain Syndrome

NCT05155384

Interstitial Cystitis Bladder Pain Syndrome

UNKNOWN NA

Supervised Exercise as a Therapeutic Strategy for Interstitial Cystitis/Bladder Pain Syndrome

NCT05699551

Interstitial Cystitis Bladder Pain Syndrome

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a randomized control trial comparing women diagnosed with interstitial cystitis/painful bladder syndrome (ICPBS) receiving usual ICPBS care to those treated with usual care supplemented with meditation and yoga. Both groups continued their current ICPBS treatment regimens. Participants in the intervention group additionally received a commercially available meditation application and a yoga tutorial video. Women in either group were followed weekly for three months. Validated questionnaires were used to compare treatment response from baseline to 12 weeks of intervention for both groups. The primary outcome was the patient report on the global response assessment (GRA), and we required a sample size of 82 patients (41 per group) to detect a difference of 30% with a 10% margin of error (alpha of 0.05) with 80% power. Other questionnaires collected included the PROMIS pain interference scale, the interstitial cystitis problem index and symptom index (ICPI and ICSI), the VAS pain scale, treatment compliance, and treatment escalation.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Interstitial Cystitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment

This is an individual treatment program devised by a pelvic floor physical therapist including a daily yoga series and mindfulness via a Smartphone app.

Group Type EXPERIMENTAL

Treatment

Intervention Type BEHAVIORAL

This is the treatment program devised win conjunction with a pelvic floor physical therapist. It is a daily yoga series and mindfulness with a Smartphone app.

Usual Cares

Intervention Type OTHER

This is standard treatment for Interstitial cystitis with your provider.

Control

These are participants undergoing regular treatment for interstitial cystitis with their providers

Group Type ACTIVE_COMPARATOR

Usual Cares

Intervention Type OTHER

This is standard treatment for Interstitial cystitis with your provider.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Treatment

This is the treatment program devised win conjunction with a pelvic floor physical therapist. It is a daily yoga series and mindfulness with a Smartphone app.

Intervention Type BEHAVIORAL

Usual Cares

This is standard treatment for Interstitial cystitis with your provider.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Mind/Body Therapy Standard Cares

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No