Mindfulness and Yoga for Pain with Interstitial Cystitis Evaluation: An RCT

Objectives: To evaluate whether addition of yoga and meditation to usual care improves treatment response in women with Interstitial Cystitis Painful Bladder Syndrome (ICBPS).

Methods: This randomized trial compared women with ICPBS receiving yoga (using standardized tutorial video)/meditation (with commercially available app) + standard care (mind/body group) compared to standard care alone (controls). Women diagnosed with ICBPS, Interstitial Cystitis Problem or Symptom Indices (ICPI, ICSI) ≥ 6 and VAS Pain scores ≥1, were eligible. Those with Hunner’s ulcers or current treatment with neuromodulation, Botulinum toxin, hydrodistension, DMSO, or cystoplasty were excluded. Both groups continued current ICPBS treatment. The primary outcome was the modified Global Response Assessment (GRA), comparing responders (moderately, markedly improved) at 12 weeks and weekly GRA scores over 12 weeks. Secondary outcomes included ICPI and ICSI results, other validated questionnaires and comparison of escalation of treatment (addition of clinical treatments) over 12 weeks.

Results: Among 97 participants, 49 (50.5%) were in the mind/body group and 48 (49.5%) in the control group. Groups were similar in age, race, ethnicity, marital status, education, opiate use, concurrent pain diagnoses, history of substance abuse and age of ICPBS diagnosis (all p>0.05). Mind/body group had more responders based on the GRA compared to controls at 12 weeks (31/43 (72%) vs. 10/39 (26%), p< 0.0001) and had superior weekly GRA results over 12 weeks (Figure 1), with mind/body group continuing to improve over time and at a faster rate than controls. Similarly, mind/body group’s ICPI/ICSI results, anxiety, depression, pain interference and pain scores were superior to controls over 12 weeks (Figure 2) Mind/body group required less treatment escalation compared to controls (mind/body 2/45 (4%), controls 21/42 (50%), p< 0.001, RR=0.09, CI 0.02-0.36).

Conclusions: Meditation and yoga in conjunction with standard ICPBS care in this population, was associated with significant improvement in ICPBS treatment response compared to standard care alone. Supplementation of usual care with mind/body therapies decreased the need for additional clinical interventions. These replicable mind/body interventions have the potential of offering accessible, additional treatment to women suffering from ICBPS.