Randomized multicenter clinical trial of myofascial physical therapy in women with interstitial cystitis/painful bladder syndrome and pelvic floor tenderness.
Study Goal
The researchers aimed to compare the efficacy and safety of pelvic floor myofascial physical therapy versus global therapeutic massage in women with newly symptomatic interstitial cystitis/painful bladder syndrome.
Results Summary
The study found that myofascial physical therapy had a significantly higher response rate (59%) compared to global therapeutic massage (26%). Both treatments reduced pain, urgency, and frequency, but there was no significant difference in these secondary outcomes between the groups.
Population
Women with interstitial cystitis/painful bladder syndrome and demonstrable pelvic floor tenderness, with symptom duration of no more than 3 years.
Effective Dosage
10 scheduled treatments (frequency not specified).
Duration
Duration of intervention not explicitly stated, but involved 10 treatments.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
pelvic floor myofascial physical therapy | increase | global response assessment response rate | women with newly symptomatic interstitial cystitis/painful bladder syndrome | 59% | significantly higher proportion responded to treatment | #1 |
global therapeutic massage | increase | global response assessment response rate | women with newly symptomatic interstitial cystitis/painful bladder syndrome | 26% | response rate | #2 |
pelvic floor myofascial physical therapy | decrease | pain, urgency and frequency ratings | women with newly symptomatic interstitial cystitis/painful bladder syndrome | - | decreased | #3 |
pelvic floor myofascial physical therapy | decrease | O'Leary-Sant IC Symptom and Problem Index | women with newly symptomatic interstitial cystitis/painful bladder syndrome | - | decreased | #4 |
global therapeutic massage | decrease | pain, urgency and frequency ratings | women with newly symptomatic interstitial cystitis/painful bladder syndrome | - | decreased | #5 |
global therapeutic massage | decrease | O'Leary-Sant IC Symptom and Problem Index | women with newly symptomatic interstitial cystitis/painful bladder syndrome | - | decreased | #6 |
pelvic floor myofascial physical therapy | no change | pain, urgency and frequency ratings | women with newly symptomatic interstitial cystitis/painful bladder syndrome | - | were not significantly different | #7 |
pelvic floor myofascial physical therapy | no change | O'Leary-Sant IC Symptom and Problem Index | women with newly symptomatic interstitial cystitis/painful bladder syndrome | - | were not significantly different | #8 |
pelvic floor myofascial physical therapy | no change | pain | women with newly symptomatic interstitial cystitis/painful bladder syndrome | - | occurring at similar rates | #9 |
global therapeutic massage | no change | pain | women with newly symptomatic interstitial cystitis/painful bladder syndrome | - | occurring at similar rates | #10 |
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.