Comparison of Bladder-Directed and Pelvic Floor Therapy in Women with Interstitial Cystitis/Bladder Pain Syndrome
Abstract
This proposal is directed at the Fiscal Year 2015 Peer Reviewed Medical Research Program Topic Area Interstitial Cystitis with focus on the priority research area of studies that assess the impact of interstitial cystitis on the ability of patients to join, or remain, as active duty military personnel. Background: Interstitial cystitis/bladder pain syndrome (IC/BPS) is a debilitating constellation of symptoms including urinary urgency, frequency, and pain related to the bladder, which predominantly affects young and middle aged adult women. Although symptoms appear to be bladder related, there has been little solid evidence linking IC/BPS symptoms with a dysfunctional bladder epithelium unless bladder ulcers are present. There is growing evidence that the bladder may actually be an innocent bystander in a more diffuse syndrome with a complex interplay of various systems and factors contributing to IC/BPS symptoms. Recent developments show that pelvic floor physical therapy (PFPT) may be a more effective treatment than bladder-directed therapy for this condition. The Intervention: Subjects in this study will be randomized to receive one of two interventions: (1) a course of twice weekly PFPT for 8 weeks or (2) bladder instillation of heparin sulphate, lidocaine, sodium bicarbonate, and kenalog twice weekly for 8 weeks. PFPT will consist of connective tissue manipulation and transvaginal treatment of abnormal pelvic floor and hip girdle connective tissue and musculature followed by extensive study measures and biomarker testing. Bladder treatment will be achieved by administering the aforementioned solution through a urinary catheter inserted into the bladder, and allowing the solution to remain in the bladder for 1 hour. Extensive study measures including biomarker-based testing will be conducted as well. Central Critical Problem: Many clinicians think that IC/BPS is a bladder problem; we aim to show that the majority of women with interstitial cystitis do not have a bladder problem even though they have urinary symptoms. Tight pelvic floor muscles, which can cause similar symptoms, might be responsible for symptoms instead. Early assessment of the pelvic floor will prevent common delays in proper diagnosis and allow for early, more effective treatment. Describe the Ultimate Applicability of the Research: Women with IC/BPS are likely to benefit directly from this study s findings by being able to return to service, especially in the field, and to a normal life for them and their families. Impact of the Research: This trial will establish pelvic floor muscle dysfunction as the dominant etiology of IC/BPS when no Hunner s ulcers are present. It will develop a standardized pelvic floor physical examination protocol and identify biomarkers associated with pelvic floor dysfunction at baseline and treatment response. It will raise the awareness of pelvic floor dysfunction as a common etiology for IC/BPS symptoms. And it will educate clinicians on the role of pelvic floor muscle physical examination, and develop an examination protocol. Thus, it will enable clinicians to more effectively identify and treat the underlying problem, and will allow women with IC/BPS a more rapid return to active duty and activities of daily living. The development of associated biomarkers also may increase the diagnostic accuracy and thus may provide additional insight into other possible etiologies for IC/BPS symptoms. It will also reduce the costs associated with unnecessary clinical testing, treating persistent symptoms, delayed diagnosis, and lost work days. How It Will Help These Patients: Women with IC/BPS will be able to get the right diagnosis at the earliest possible time and an effective, long-lasting treatment allowing them to return to service and to a normal life for them and their families.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 31, 2017
- Source ID
- W81XWH1610307
Entities
People
- Kenneth Peters
Organizations
- Beaumont Health
- United States Army