title: Randomized multicenter clinical trial of myofascial physical therapy in women with interstitial cystitis/painful bladder syndrome and pelvic floor tenderness.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Loyola University Medical Center, Maywood, Illinois, USA. mary.fitzgerald6@va.gov
authors.forename: M P
authors.initials: MP
authors.lastname: FitzGerald
authors.forename: C K
authors.initials: CK
authors.lastname: Payne
authors.forename: E S
authors.initials: ES
authors.lastname: Lukacz
authors.forename: C C
authors.initials: CC
authors.lastname: Yang
authors.forename: K M
authors.initials: KM
authors.lastname: Peters
authors.forename: T C
authors.initials: TC
authors.lastname: Chai
authors.forename: J C
authors.initials: JC
authors.lastname: Nickel
authors.forename: P M
authors.initials: PM
authors.lastname: Hanno
authors.forename: K J
authors.initials: KJ
authors.lastname: Kreder
authors.forename: D A
authors.initials: DA
authors.lastname: Burks
authors.forename: R
authors.initials: R
authors.lastname: Mayer
authors.forename: R
authors.initials: R
authors.lastname: Kotarinos
authors.forename: C
authors.initials: C
authors.lastname: Fortman
authors.forename: T M
authors.initials: TM
authors.lastname: Allen
authors.forename: L
authors.initials: L
authors.lastname: Fraser
authors.forename: M
authors.initials: M
authors.lastname: Mason-Cover
authors.forename: C
authors.initials: C
authors.lastname: Furey
authors.forename: L
authors.initials: L
authors.lastname: Odabachian
authors.forename: A
authors.initials: A
authors.lastname: Sanfield
authors.forename: J
authors.initials: J
authors.lastname: Chu
authors.forename: K
authors.initials: K
authors.lastname: Huestis
authors.forename: G E
authors.initials: GE
authors.lastname: Tata
authors.forename: N
authors.initials: N
authors.lastname: Dugan
authors.forename: H
authors.initials: H
authors.lastname: Sheth
authors.forename: K
authors.initials: K
authors.lastname: Bewyer
authors.forename: A
authors.initials: A
authors.lastname: Anaeme
authors.forename: K
authors.initials: K
authors.lastname: Newton
authors.forename: W
authors.initials: W
authors.lastname: Featherstone
authors.forename: R
authors.initials: R
authors.lastname: Halle-Podell
authors.forename: L
authors.initials: L
authors.lastname: Cen
authors.forename: J R
authors.initials: JR
authors.lastname: Landis
authors.forename: K J
authors.initials: KJ
authors.lastname: Propert
authors.forename: H E
authors.initials: HE
authors.lastname: Foster
authors.forename: J W
authors.initials: JW
authors.lastname: Kusek
authors.forename: L M
authors.initials: LM
authors.lastname: Nyberg
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018856:Cystitis, Interstitial / Q000628:therapy*; D005260:Female; D006801:Humans; D008405:Massage / Q000379:methods*; D008875:Middle Aged; D017773:Pelvic Floor; D017699:Pelvic Pain / Q000628:therapy*; D016037:Single-Blind Method; D055815:Young Adult