Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation

NCT04820855 | Completed Results

• 1 other identifier: 20-664
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Interstitial Cystitis

Keywords

Interstitial cystitis; Complementary and Alternative medicine; Yoga; Meditation

Outcome Measures

Primary Outcomes (1)

• Number of Participants Designated as "Treatment Responders" Based on Global Response Assessment (GRA)

  This is a validated single question that determines treatment response. Participants were considered "treatment responders" if they answered "markedly improved/moderately improved" on the GRA at 12 weeks.

  3 months

Secondary Outcomes (7)

• O'Leary-Sant: Interstitial Cystitis Symptom Index

  change from baseline to 3 months

• O'Leary-Sant: Interstitial Cystitis Problem Index

  change from baseline to 3 months

• Pain VAS Score

  change from baseline to 3 months

• Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale

  change from baseline to 3 months

• Hospital Anxiety and Depression Scale (HADS) Depression Subscale

  change from baseline to 3 months

Study Arms (2)

Treatment

EXPERIMENTAL

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

Behavioral: Treatment; Other: Usual Cares

Control

ACTIVE COMPARATOR

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

Other: Usual Cares

Interventions

Treatment 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.

Also known as: Mind/Body Therapy

Treatment

Usual Cares OTHER

This is standard treatment for Interstitial cystitis with your provider.

Also known as: Standard Cares

Control; Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87106, United States

Location

Related Publications (1)

• Dao AN, Komesu YM, Jansen SM, Petersen TR, Meriwether KV. Augmentation of Interstitial Cystitis-Bladder Pain Syndrome Treatment With Meditation and Yoga: A Randomized Controlled Trial. Obstet Gynecol. 2025 Feb 1;145(2):186-195. doi: 10.1097/AOG.0000000000005820. Epub 2025 Jan 2.

  PMID: 39746210 DERIVED

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Therapeutics; Mind-Body Therapies

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies

Results Point of Contact

• Title: Dr. Angela Dao
• Organization: University of New Mexico Health Sciences Center

angela.dao@gmail.com

5059678428

Study Officials

• Kate Meriwether, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 29, 2021
• Study Start: May 18, 2021
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: March 5, 2025
• Results First Posted: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)