Rosia Parrish
Jennifer Pilon
Daeyon JooRi Jun
Kris Somol, ND
The American Urological Association defines Interstitial Cystitis (IC)/Pelvic Bladder Syndrome as an unpleasant sensation perceived to be related to the urinary bladder that is associated with lower urinary tract symptoms greater than 6 weeks’ duration, in the absence of infection or other identifiable causes.1 The condition is 5 to 10 times more common in women than in men. In the absence of clear diagnostic criteria, this condition is underdiagnosed, with an estimated prevalence of 3 to 8 million women in the United States.2
The treatment of IC is a clinical challenge. As a diagnosis of exclusion without a clear etiology, first-line treatment strategies for IC are varied and tend to focus on food-trigger avoidance, stress reduction, and bladder retraining. However, these therapies remain ineffective for some patients, warranting implementation of second-line therapies. These include pelvic floor physical therapy, amitriptyline, antihistamines, and intravesical drug combinations.3
The question of whether myofascial physical therapy (MPT) is an effective treatment for IC is a particularly relevant question for naturopathic doctors, many of whom are trained in and practice a variety of hands-on myofascial therapies. When choosing from among these second-line treatments, naturopathic philosophy would suggest that manual physical therapy would be more effective than conventional treatments in treating the cause of the condition, particularly in cases where somatic abnormalities of the pelvic floor are contributing to the syndrome. The goal of this literature review is to investigate the following clinical question: In female patients with a diagnosis of interstitial cystitis, does the use of myofascial physical therapy decrease symptoms of urinary urgency, urinary frequency, and pelvic pain when compared with conventional treatments?
Literature Search
A search of PubMed and Embase was performed, including combinations of the following terms (designated medical subject headings and other relevant terms): physiotherapy, interstitial cystitis, therapeutics, complementary therapies, physical therapy modalities, alternative medicine, massage, pelvic floor rehabilitation, electrostimulation, and physiatrics. The original searches were done without limiting them to randomized controlled trials (RCTs), in order to accurately assess the current state of the research and identify possible directions for other searches. Combinations of the terms interstitial cystitis, physical therapy modalities, therapeutics, and massage revealed studies that were the most relevant to our clinical question. In the final analysis, only English language RCTs conducted within the last 10 years that were available as free, full-text articles through Bastyr University were considered for review. Complete detail of searches and results is shown in Table 1.
There were 3 English-language RCTs that fulfilled our final search criteria. Of note, there were no studies that directly compared MPT with conventional drug treatments for IC. One particular study was ultimately chosen for review because it was most relevant to the clinical question being asked and to the scenarios which we would be likely to encounter in naturopathic practice.4 This study was performed solely on women (as opposed to other studies which included both women and men with painful bladder syndrome), who had not experienced relief with at least 1 course of conventional first-line management for IC. This is relevant to the fact that almost all patients experiencing IC symptoms are female. Additionally, it is consistent with how many patients seek out naturopathic medicine after experiencing a lack of success with conventional treatments. In a primary care practice, adult women may present with IC within a wide range of ages. This clinical reality is reflected in the study, which included women aged 18-77. Finally, the outcomes measured in this study not only included specific frequency of symptoms, but also a global, subjective measure of improvement as determined by the patient. This contributed to our choice of study, since including this outcome may better reflect changes in quality of life post-treatment than symptom-based questionnaires alone.
Table 1: MeSH Search Terms & Number of Papers from Each Search
| Search Terms (MESH) | Database Searched | # Papers Found |
| physiotherapy AND interstitial cystitis | Embase | 108 |
| cystitis, interstitial AND physical therapy modalities | PubMed | 103 |
| cystitis, interstitial AND therapeutics AND complementary therapies | PubMed | 33 |
| cystitis, interstitial AND therapeutics AND physical therapy modalities | PubMed | 100 |
| cystitis, interstitial AND massage | PubMed | 8 |
| Interstitial cystitis AND alternative medicine | Embase | 78 |
| Interstitial cystitis AND massage | Embase | 27 |
| cystitis, interstitial AND therapeutics AND physical therapy modalities
(Search filtered to include RCTs only) |
PubMed | 6
|
| cystitis, interstitial AND physical therapy modalities
(Search filtered to include RCTs only) |
PubMed | 6 |
| Pelvic floor rehab | PubMed | 228 |
| Pelvic floor rehab AND interstitial cystitis | PubMed | 0 (4 that were not RCTs) |
| Electrostimulation AND interstitial cystitis | PubMed | 0 (4 that are not RCTs) |
| Electrostimulation AND cystitis | PubMed | 0 (8 that are not RCTs) |
| Physiatrics AND cystitis | PubMed | 0 (4 that are not RCTs) |
Study Methods
The study chosen for review4 sought to answer whether females aged 18-77 with a clinical diagnosis of IC or painful bladder syndrome (PBS), using a standardized myofascial physical therapy protocol (MPT) as compared to a standardized Western global therapeutic massage (GTM) program, show improvement of overall symptom picture and/or specific symptoms of pain, frequency, urgency, and sexual function. Participants were recruited from July of 2008 through May of 2009 across 11 academic clinical centers across North America, and the study lasted 12 weeks. Physical therapists (PTs) providing the MPT were trained in a standardized protocol to minimize variability between therapists. The protocol was not described in the paper chosen, but has been described in detail in a feasibility study conducted by the same authors.5
There were 2 arms of the study: MPT and GTM. MPT is a manipulation technique that is both internal and external to the pelvic floor (focusing specifically on abdominal, pelvic, and hip girdle muscles and other tissue). GTM, in contrast, is a full-body therapeutic massage. Those patients in the GTM treatment group had a series of 10 one-hour massages.
The inclusion criteria included clinical diagnosis of IC/PBS, average recorded ratings for bladder pain, frequency, and urgency of at least 3/10, and present for a minimum of 3 months and a maximum of 3 years. Furthermore, pelvic floor tenderness on vaginal examination, identified by the study’s physician and confirmed by a PT, was required for study inclusion. There were no significant differences in demographics between the MPT and the GTM groups at baseline. Demographic factors assessed were age, ethnicity, education level, employment status, and annual family income; demographic factors were listed in the feasibility study cited in this article.5 Of note, no other specific prognostic factors relating to their clinical diagnosis were assessed, including smoking. Most of the patients were Caucasian, and the exclusion of women without pelvic pain on vaginal examination eliminated a significant number of IC sufferers for whom this treatment might be beneficial. For this reason, the results are difficult to generalize to the population at large.
Patient assignment to treatment groups was randomized. Physical examiners and nurses collecting data were blinded to treatment assignment, but there was no indication of whether investigators were blinded from the process of randomization. Outcome assessors and all study coordinators were also blinded to the group allocation. Randomization process occurred via a pre-specified sequence distributed in a series of sealed envelopes to receive MPT or GTM. Patients were analyzed in the groups to which they were randomized; there was no crossover between the groups. Even though the patients were not told outright what group they were assigned to, given the differences between MPT and GTM, it is likely that they were aware of the group to which they were assigned.
Outcomes were measured with the 7-point Global Response Assessment (GRA) scale, the O’Leary Sant IC Symptom and Problem Index, a 24-hour urinary voiding diary, the 2000 Female Sexual Functioning Index, and the 12-Item Short-Form Health Survey.
Of the 81 patients recruited, 78 (96%) were able to complete the full 12-week duration of the study (including initial follow-up at the completion of treatment phase at 12 weeks, and additional follow-up for 3 months after the 12-week follow-up). Of these 78 participants, 72 (92%) completed at least 7 of the 10 treatments that were assigned to them during the 12 weeks: In the MPT group 55% completed all 10 treatments, and in the GTM group 38% of the GTM group finished 100% of their 10 treatments. The 3 who withdrew from the study had received <5 treatments. During the follow-up phase of the study, the retention rate was smaller, with 77% of the MPT, and 67% of the GTM, participating. Because many of the study’s subjects did not participate in the final follow-up session, it is difficult to draw conclusions about durability of treatment.
Study Outcomes
The primary outcome of this study was that 59% of the MPT group, compared to 26% in the GTM group, reported moderate or marked improvement (p=0.0012) on the GRA scale. Within the GTM group, 43% reported no change in symptoms, compared to only 18% of the MPT group reporting no change. Both treatment groups reported improved symptoms via the O’Leary Sant IC Symptom and Problem Index of pain, urgency, frequency; there were also reported improvements in quality of life as well. No statistical significance was noted among these secondary symptom outcomes of the study. The Mantel-Haenszel test was employed to take into account the need to control variability at the 11 sites. The Number-Needed-to-Treat to determine 30% effect was 88, and only 81 were recruited; however, this study was still significantly powered.
Adverse events (AE) were also reported. Bladder or pelvic pain was the most commonly reported AE, reported in 14% of the participants. There was no statistical significance in the number of AEs reported by each treatment group. The authors conjectured that the AEs reported, especially that of pain, in part had to do with the intermittent nature of the disorder and was not necessarily related to treatment intervention. Other AEs reported were infection (reported by 12% of the patients), constitutional symptoms like fever (11%), and digestive symptoms (10%).
The age range of subjects in the study (18-77) and the duration of their symptoms (3 months to 3 years) are similar to patients who would potentially be seen in naturopathic medical clinics. It is feasible for naturopathic physicians to determine pelvic floor tenderness during a vaginal exam and to discern suitable candidates for this treatment option. It would also be feasible to refer patients to physical therapists for co-management. However, determining the optimal elements of an effective MPT regimen and finding PTs who can deliver effective pelvic floor MPT might be an obstacle.
Discussion
The study reviewed here answered the question of whether the use of MPT can improve symptoms associated with IC, including but not limited to urinary urgency, urinary frequency, and pelvic pain. However, the paper did not compare the effects of MPT to conventional treatments, such as food-trigger avoidance, bladder retraining methods, or pain medications. In fact, the study did not disclose whether subjects were concurrently using any other treatment modalities while participating in the study, potentially biasing the results.
Further questions raised by the literature review process and the results of this paper include whether the results of the study can be generalized to the IC patient population at large. For example, it is questionable whether MPT would also be beneficial to patients who do not demonstrate pelvic tenderness on examination. This also points to the currently inadequate understanding we have about the relationship between somatic abnormalities and IC. Another aspect of whether the study could be generalizable centers around the fact that study participants were primarily Caucasian.
A future study examining the durability of subjects’ improvement with this therapy would make the results more clinically meaningful. Due to the loss to follow-up at 3 months post-treatment, the question of how long the beneficial effects of MPT last, remains. It would be very exciting, indeed, to investigate whether the effects are long-lasting and could potentially be a cure of sorts to the unending suffering experienced by patients with interstitial cystitis.
Finally, developing an effective training program for physical therapists and other providers would be critical so that this therapy would become accessible to a large number of patients.
Concluding Comments
The evidence from the study reveals that MTP is indeed beneficial for improving symptoms of IC, suggesting that physical therapy is an important modality to consider in a treatment plan for a patient suffering from the disease. It adds credibility to the idea that there are specific pelvic somatic abnormalities involved with IC, as the study showed the treatment effect was not merely due to general therapeutic touch.
The process of finding a robust paper to review to answer our question yielded only 1 study that fit the aforementioned criteria. This points to the lack of research available on myofascial physical therapies to treat IC.
However, even with the limited evidence, considering the strength of the paper reviewed and the fact that no serious adverse events were reported, MPT can be considered a safe and potentially effective therapy for IC that could be recommended and provided to patients. The question as to whether it is more effective than other first- and second-line treatments still remains and requires further research.
Rosia Parrish, Jennifer Pilon, and Daeyeon JooRi Jun are naturopathic students in their last year at Bastyr University in Seattle, WA. Rosia Parrish received a BA in anthropology, with an emphasis in medical anthropology and pharmaceutical politics. She received the highest honors of Summa Cum Laude with Distinction from the University of CO at Boulder after completing her honor’s thesis, “Unethical Ethics: An Anthropological Study of AZT Clinical Trial Compliance with Research Regulations.” Jennifer Pilon was trained at Thompson River University in Kamloops, BC. Jen’s background is human and animal biology, and human nutrition. She completed her undergraduate thesis on “Alternative and Complementary Therapies for Metabolic Syndrome.” Daeyeon JooRi Jun received her BS from Bates College in Maine. She completed her Neuroscience thesis on gendered effects of meditation, and her Women & Gender Studies thesis on “The Politics of Legitimization of Complementary and Alternative Medicine in the U.S.”
Kris Somol, ND, is an adjunct academic and clinical faculty member at Bastyr Center for Natural Health in Seattle, WA; she has also been practicing primary-care family medicine since 2005. Dr Somol has spent 20 years in the healing profession and 10 years as a public educator on botanical medicine. She is especially focused on preventive care and sees a wide range of acute and chronic conditions. Since 2008, Dr Somol has lectured on asthma in adolescence, food allergies and food allergy testing, and updates in women’s health issues at various medical conferences. She has also written articles for the Seattle Times on women’s health.
References:
- Hanno PM, Burks DA, Clemens JQ, et al. AUA guideline for the diagnosis and treatment of interstitial cystitis/bladder pain syndrome. J Urol. 2011;185(6):2162-2170.
- Berry SH, Elliott MN, Suttorp M, et al. Prevalence of symptoms of bladder pain syndrome/interstitial cystitis among adult females in the United States. J Urol. 2011;186(2):540-544.
- Clinical Key First Consult. Interstitial Cystitis. Clinical Key Web site. https://www.clinicalkey.com/#!/topic/interstitial%2520cystitis. Accessed October 29, 2014.
- FitzGerald MP, Payne CK, Lukacz ES, et al. 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.
- Fitzgerald MP, Anderson RU, Potts J, et al. Randomized multicenter feasibility trial of myofascial physical therapy for the treatment of urological chronic pelvic pain syndromes. J Urol. 2013;189(1 Suppl):S75-S85.
