Randomized multicenter clinical trial of myofascial physical therapy in women with interstitial cystitis/painful bladder syndrome and pelvic floor tenderness Journal Article


Authors: FitzGerald, M. P.; Payne, C. K.; Lukacz, E. S.; Yang, C. C.; Peters, K. M.; Chai, T. C.; Nickel, J. C.; Hanno, P. M.; Kreder, K. J.; Burks, D. A.; Mayer, R.; Kotarinos, R.; Fortman, C.; Allen, T. M.; Fraser, L.; Mason-Cover, M.; Furey, C.; Odabachian, L.; Sanfield, A.; Chu, J.; Huestis, K.; Tata, G. E.; Dugan, N.; Sheth, H.; Bewyer, K.; Anaeme, A.; Newton, K.; Featherstone, W.; Halle-Podell, R.; Cen, L.; Landis, J. R.; Propert, K. J.; Foster, H. E., Jr; Kusek, J. W.; Nyberg, L. M.; Brubaker, L; Interstitial Cystitis Collaborative Research Network
Article Title: Randomized multicenter clinical trial of myofascial physical therapy in women with interstitial cystitis/painful bladder syndrome and pelvic floor tenderness
Abstract: PURPOSE: We determined the efficacy and safety of pelvic floor myofascial physical therapy compared to global therapeutic massage in women with newly symptomatic interstitial cystitis/painful bladder syndrome. MATERIALS AND METHODS: A randomized controlled trial of 10 scheduled treatments of myofascial physical therapy vs global therapeutic massage was performed at 11 clinical centers in North America. We recruited women with interstitial cystitis/painful bladder syndrome with demonstrable pelvic floor tenderness on physical examination and a limitation of no more than 3 years' symptom duration. The primary outcome was the proportion of responders defined as moderately improved or markedly improved in overall symptoms compared to baseline on a 7-point global response assessment scale. Secondary outcomes included ratings for pain, urgency and frequency, the O'Leary-Sant IC Symptom and Problem Index, and reports of adverse events. We compared response rates between treatment arms using the exact conditional version of the Mantel-Haenszel test to control for clustering by clinical center. For secondary efficacy outcomes cross-sectional descriptive statistics and changes from baseline were calculated. RESULTS: A total of 81 women randomized to the 2 treatment groups had similar symptoms at baseline. The global response assessment response rate was 26% in the global therapeutic massage group and 59% in the myofascial physical therapy group (p=0.0012). Pain, urgency and frequency ratings, and O'Leary-Sant IC Symptom and Problem Index decreased in both groups during followup, and were not significantly different between the groups. Pain was the most common adverse event, occurring at similar rates in both groups. No serious adverse events were reported. CONCLUSIONS: A significantly higher proportion of women with interstitial cystitis/painful bladder syndrome responded to treatment with myofascial physical therapy than to global therapeutic massage. Myofascial physical therapy may be a beneficial therapy in women with this syndrome.
Journal Title: The Journal of urology
Volume: 187
Issue: 6
ISSN: 1527-3792; 0022-5347
Publisher: Unknown  
Journal Place: United States
Date Published: 2012
Start Page: 2113
End Page: 2118
Language: eng
DOI/URL:
Notes: CI: Copyright (c) 2012; ClinicalTrials.gov/NCT00733603; GR: U01 DK065178-05/DK/NIDDK NIH HHS/United States; GR: U01 DK065190-06/DK/NIDDK NIH HHS/United States; GR: U01 DK065192-05/DK/NIDDK NIH HHS/United States; GR: U01 DK065202-04S2/DK/NIDDK NIH HHS/United States; GR: U01 DK065209/DK/NIDDK NIH HHS/United States; GR: U01 DK065209-06/DK/NIDDK NIH HHS/United States; GR: U01 DK065213-06/DK/NIDDK NIH HHS/United States; GR: U01 DK065214-05/DK/NIDDK NIH HHS/United States; GR: U01 DK065215-05/DK/NIDDK NIH HHS/United States; GR: U01 DK065255-06/DK/NIDDK NIH HHS/United States; GR: U01 DK065267-06/DK/NIDDK NIH HHS/United States; GR: U01 DK065271/DK/NIDDK NIH HHS/United States; GR: U01 DK065271-05/DK/NIDDK NIH HHS/United States; JID: 0376374; NIHMS350631; OID: NLM: NIHMS350631; OID: NLM: PMC3351550; 2011/10/21 [received]; 2012/04/12 [aheadofprint]; ppublish