Gynecology: Original Research
A Randomized Controlled Trial
Dao, Angela N. MD; Komesu, Yuko M. MD; Jansen, Sierra M. MD; Petersen, Timothy R. PhD; Meriwether, Kate V. MD
Department of Obstetrics and Gynecology, the Division of Urogynecology, and the Department of Anesthesiology and Critical Care Medicine, University of New Mexico Health Sciences Center, Albuquerque, New Mexico.
Corresponding author: Yuko M. Komesu, MD, Department of Obstetrics and Gynecology and Division of Urogynecology, University of New Mexico Health Science Center; [emailprotected].
Support was received from an American Urogynecologic Society Foundation grant. This project was supported in part by the Dedicated Health Research Funds from the University of New Mexico School of Medicine Research Allocation Committee and the University of New Mexico Department of Obstetrics and Gynecology.
Each author has confirmed compliance with the journal's requirements for authorship.
Financial Disclosure Angela N. Dao has been a consultation for Juniper Medical. Kate V. Meriwether: royalties from Elsevier publishing (book editing), royalties from UpToDate (peer review), consultation for Juniper Medical, editorial board position (honoraria or travel reimbursement) for journals of Obstetrics and Gynecology and Urogynecology, grant section for Centers for Disease Control (CDC) RFA-DP-24-031: Epidemiologic Cohort Study of Interstitial Cystitis. Her institution received a Caldera Medical 522 grant for which Dr. Meriwether is a site PI and for which she did not receive personal funds. The other authors did not report any potential conflicts of interest.
Presented at AUGS PFD Week, October 22–25, 2024, Washington, DC.
The authors thank Jill H. Osborn, MA, Founder of the Interstitial Cystitis Network, and the Interstitial Cystitis Network participants for their enormous contribution to this study. They also thank Dustienne Miller, PT, for her work on the design and production of the yoga videos.
Peer reviews and author correspondence are available at https://links.lww.com/AOG/D947.
Obstetrics & Gynecology 145(2):p 186-195, February 2025. | DOI: 10.1097/AOG.0000000000005820
- Buy
- SDC
OBJECTIVE:
To investigate whether yoga and meditation added to usual care improves treatment response in women with interstitial cystitis–bladder pain syndrome.
METHODS:
This randomized trial compared women with interstitial cystitis–bladder pain syndrome receiving standard care alone (control group) with those receiving standard care plus meditation and yoga (mind–body group). Standard care was defined as behavioral changes or medications recommended by the American Urological Association. Individuals in the control group received standard care, and those in the mind–body group received standard care augmented with a commercially available meditation application and standardized yoga tutorial video. Both groups continued their current interstitial cystitis–bladder pain syndrome standard care treatments. The primary outcome was the modified GRA (Global Response Assessment), comparing responders (moderately, markedly improved) with nonresponders at 12 weeks. On power analysis assuming α=5% and β=80%, a sample size of 82 participants was required to find 30% difference on the GRA between groups. Weekly GRA scores over 12 weeks were also compared. Secondary outcomes included ICPI (Interstitial Cystitis Problem Index)/ICSI (Interstitial Cystitis Symptom Index), pain, pain interference, anxiety/depression, and self-efficacy scores and treatment escalation over 12 weeks.
RESULTS:
Among 97 randomized participants (49 mind–body group, 48 control group), groups did not differ in characteristics or symptoms at baseline. The mind–body group had more GRA responders compared with the control group at 12 weeks (31/43 [72.1%] vs 10/39 [25.6%], relative risk [RR] 2.8, 95% CI, 1.6–4.6), corroborated by superior weekly GRA results over 12 weeks. The mind–body group had superior beneficial change on the ICPI (RR 1.8, 95% CI, 0.5–3.1), ICSI (RR 1.9, 95% CI, 0.2–3.6), and pain (RR 1.4, 95% CI, 0.4–2.5) scores than the control group at 12 weeks. The mind–body group required less treatment escalation than the control group (2/45 [4.4%] vs 14/42 [33.3%], RR 0.13, 95% CI, 0.03–0.55).
CONCLUSION:
The addition of meditation and yoga to standard interstitial cystitis–bladder pain syndrome care was associated with improved treatment response and required fewer additional interventions compared with standard care alone.
CLINICAL TRIAL REGISTRATION:
ClinicalTrials.gov, NCT04820855.
Full Text Access for Subscribers:
You can read the full text of this article if you:
Log In Access through Ovid
