Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation

Interstitial Cystitis Clinical Trial

— MYPAICE  

Official title:

Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04820855
• Other study ID #: 20-664
• Status: Completed
• Phase: N/A
• Start date: May 18, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2024
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis

Intervention

Behavioral:
• 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.

Other:
• Usual Cares
This is standard treatment for Interstitial cystitis with your provider.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Response Assessment	This is a validated single question that determines treatment response	3 months
Secondary	O'Leary-Sant Symptom and Problem Index	This is a validated questionnaire to evaluate interstitial cystitis symptoms.	3 months