FitzGerald MP, Payne CK, Lukacz ES, et al; Interstitial Cystitis Collaborative Research Network. Randomized multicenter clinical trial of myofascial physical therapy in women with interstitial cystitis/painful bladder syndrome and pelvic floor tenderness. J Urol. 2012;187(6):2113-2118.  

Interstitial cystitis/painful bladder syndrome (IC/PBS) is characterized by a highly variable clinical course. Although treatment of patients with this disorder continues to be suboptimal, evidence suggests that myofascial physical therapy (MPT) techniques can provide clinically significant relief of IC/PBS symptoms.^1-3 A large group of researchers from academic health centers in North America conducted a single-blind, randomized controlled trial to assess the effectiveness and safety of pelvic floor MPT vs global therapeutic massage (GTM) in women with IC/PBS. 

A total of 81 women aged between 18 and 77 years (mean age, 43 years) were recruited at 11 clinical study sites in North America. The majority of patients were white. Inclusion criteria were a clinical diagnosis of IC/PBS and recorded ratings of at least 3 on 0- to 10-point severity scales for bladder pain, frequency, and urgency, for at least 3 months. An additional inclusion requirement was the identification of pelvic floor tenderness during a vaginal examination performed by a physician, followed by confirmation of this finding by a physical therapist. Exclusion criteria included having previously received pelvic floor MPT and not having ever received standard IC/PBS therapy. The 81 patients were randomly allocated to receive MPT (n=39) or GTM (n=42). 

To standardize treatment, physical therapists from each site received training at a central location and were certified in the performance of each intervention. Myofascial physical therapy consisted of targeted internal and external tissue manipulation that honed in on the muscles and connective tissues of the abdomen, pelvic floor, and hip girdle. Global therapeutic massage consisted of a typical program of full-body Western massage. Each patient underwent ten 60-minute treatment interventions during a 12-week period. Patients were blinded to which therapy they received, and physician examiners and data collectors were blinded to the therapy assignment for each patient. 

The primary outcome was the proportion of patients who indicated having a moderate or marked improvement in overall symptoms at week 12, as determined by a global response assessment (GRA) that provided 7 response options (markedly worse, moderately worse, slightly worse, same, slightly improved, moderately improved, and markedly improved). Such patients were known as responders, whereas patients who did not provide data on the primary outcome or who withdrew from the study were known as nonresponders. Secondary outcome measures included patient-reported bladder pain, urgency, and frequency ratings on scales of 0 to 10; measurements of urinary frequency and volume obtained from a 24-hour voiding diary; scores on the O'Leary-Sant IC Symptom Index, the O'Leary-Sant IC Problem Index, and the 2000 Female Sexual Functioning Index; and responses to the 12-item Short Form Health Status Questionnaire and the Female Symptom Questionnaire. All outcome measures were determined at baseline and again at 12 weeks (after the series of intervention sessions was completed). 

A total of 59% of the patients receiving MPT and 26% of the patients receiving GTM were considered to be GRA responders. Although improvements in secondary outcome measures were noted for patients in both the MPT and GTM groups, no statistically significant differences in such measures were noted between the 2 groups. The fact that the proportion of responders in the MPT group was more than double that of responders in the GTM group led the authors to justify favoring clinical use of MPT for the treatment of IC/PBS and other pelvic pain conditions. 

Pain, which was the most common adverse event, occurred at nearly the same rate in both the MPT and GTM groups. Serious adverse events, however, were not recorded. I was gratified that the authors acknowledged viscerosomatic or somatovisceral interactions as the cause of pain (ie, pain that is referred to the low back and pelvis as a result of a primary pelvic visceral abnormality or as a result of a structural injury or abnormality that causes a secondary visceral hypersensitivity). 

The authors state that the generalizability of their results may be limited because of the stringent nature of the study's inclusion criteria. They also indicate that it is unknown whether MPT would benefit patients who have symptoms of IC/PBS but have no pelvic floor tenderness. The study does not provide data on either the durability of the benefit received or whether this benefit could be optimized if MPT were provided periodically over a longer, multiple-year period.