Randomized multicenter clinical trial of myofascial physical therapy in women with interstitial cystitis/painful bladder syndrome and pelvic floor tenderness
M P FitzGerald, C K Payne, E S Lukacz, C C Yang, K M Peters, T C Chai, J C Nickel, P M Hanno, K J Kreder, D A Burks, R Mayer, R Kotarinos, C Fortman, T M Allen, L Fraser, M Mason-Cover, C Furey, L Odabachian, A Sanfield, J Chu, K Huestis, G E Tata, N Dugan, H Sheth, K Bewyer, A Anaeme, K Newton, W Featherstone, R Halle-Podell, L Cen, J R Landis, K J Propert, H E Foster Jr, J W Kusek, L M Nyberg, Interstitial Cystitis Collaborative Research Network, Jane Miller, Charles H Muller, Jean Kalhoff, James Bassuk, Sharon Downing, Robert F Bale Jr, Rajesh Shinghal, Rodney Anderson, Debra Clay, Anna Ramakrishnan, Charles Nager, Marianne Chenoweth, Eleanor Anton, Cheryl Wolfert, Loni Lampkins, Susan Keay, Rosanna Dinh, Rupali Sangrampurkar, Alvaro Morales, Laurel Emerson, Lesley Carr, Joseph Downey, Janet Clark-Pereira, Sylvia Robb, Linda Brubaker, Janet Rindels, Grace Bucher, Diane K Newman, Sylvia Salazar, Jennifer Milado, Louis Moy, Michael O'Donnell, Susan Lutgendorf, Mary Eno, Kelly O'Berry, Kandis Rivers, Samina Romero, Michelle Peabody, Edward Messing, Elizabeth Betty Smith, Kay Rust, Jay Reeder, Keith Mickelberg, Ted Barrell, Shannon Chuai, Christopher Mullins, Mary Harris, Vickie Ratner, M P FitzGerald, C K Payne, E S Lukacz, C C Yang, K M Peters, T C Chai, J C Nickel, P M Hanno, K J Kreder, D A Burks, R Mayer, R Kotarinos, C Fortman, T M Allen, L Fraser, M Mason-Cover, C Furey, L Odabachian, A Sanfield, J Chu, K Huestis, G E Tata, N Dugan, H Sheth, K Bewyer, A Anaeme, K Newton, W Featherstone, R Halle-Podell, L Cen, J R Landis, K J Propert, H E Foster Jr, J W Kusek, L M Nyberg, Interstitial Cystitis Collaborative Research Network, Jane Miller, Charles H Muller, Jean Kalhoff, James Bassuk, Sharon Downing, Robert F Bale Jr, Rajesh Shinghal, Rodney Anderson, Debra Clay, Anna Ramakrishnan, Charles Nager, Marianne Chenoweth, Eleanor Anton, Cheryl Wolfert, Loni Lampkins, Susan Keay, Rosanna Dinh, Rupali Sangrampurkar, Alvaro Morales, Laurel Emerson, Lesley Carr, Joseph Downey, Janet Clark-Pereira, Sylvia Robb, Linda Brubaker, Janet Rindels, Grace Bucher, Diane K Newman, Sylvia Salazar, Jennifer Milado, Louis Moy, Michael O'Donnell, Susan Lutgendorf, Mary Eno, Kelly O'Berry, Kandis Rivers, Samina Romero, Michelle Peabody, Edward Messing, Elizabeth Betty Smith, Kay Rust, Jay Reeder, Keith Mickelberg, Ted Barrell, Shannon Chuai, Christopher Mullins, Mary Harris, Vickie Ratner
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.
Trial registration: ClinicalTrials.gov NCT00733603.
Copyright © 2012 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.
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Source: PubMed