About this trial
Myofascial Pelvic Pain (MPP) is a frequently overlooked musculoskeletal cause of chronic pelvic pain affecting 10-20% of all adult women. Despite high prevalence and societal costs, few effective treatments exist and are difficult to access due to shortages of skilled personnel. Treatments for MPP using electrical stimulation to induce muscle fatigue have proven efficacy at reducing pain, improving circulation, and promoting tissue healing, but have proven difficult to implement in gynecologic practice. The aim of this three-arm randomized study is to evaluate the utility of transvaginal electrical stimulation at a fixed frequency of 200 Hz in women with symptomatic MPP in comparison to the standard, first-line treatment with education, stretching, and low-impact exercise.
Nursing staff without prior training will be taught to deliver this high-frequency transvaginal electrical stimulation (HF-TES) treatment using the device. Responses to treatment provided by a specialist physician and licensed vocational nurse will be compared. Patients with \>50% pain improvement will determine the effectiveness of HF-TES. Responses to treatment provided by a specialist physician and licensed vocational nurse will also be compared. Participants will be followed for 3 months following treatment completion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women between 18 and 65 years of age
Pelvic pain for more than 6 months duration
Report an average daily pain intensity score of at least 4 (on a 0 to 10 scale)
Palpable trigger points in internal pelvic floor muscles on standardized myofascial pelvic floor exam
Disqualifiers
Inability to participate in weekly clinic visits
Prior invasive pelvic procedures for pain (e.g., prior pelvic surgery, sacroiliac joint injections, ganglion impar block, bladder instillations, sacral neuromodulation, intradetrusor or intramuscular Botox®)
Active urinary tract infection (UTI) or vaginal infection
Pregnancy, childbirth during the previous12 months, currently planning pregnancy
Trial design
Parallel
Treatments tested in this trial
Urostym
Deviceelectric pelvic floor muscle stimulator
Standard care
Behavioralpatient education on home exercises and stretching
Treatment groups
Trial outcomes
Primary outcomes
Change of myofascial pelvic pain symptoms
The primary outcome will measure a change in pain on the 11-point Numeric Pain Rating Scale, where the minimum value of 0 indicates no pain and the maximum value of 10 indicates worse possible pain. Higher scores are associated with a worse outcome. Positive outcomes would have a 2-point reduction in mean pain intensity from baseline to post-treatment.
Patient perception of treatment delivery by an LVN in comparison to specialist MD
Patients will complete the Patient Global Impression of Improvement (PGI-I) questionnaire, where the minimum value of 1 indicates a "very much better" change in pain and the maximum value of 7 indicates a "very much worse" change in pain. Responses will be compared between the two provider groups.
Patient satisfaction with treatment delivery by an LVN in comparison to specialist MD
The investigators will use a Likert scale that measures satisfaction with treatment, where 0 = not satisfied and 10 = completely satisfied. Scores between the LVN and MD group will be compared.
Benefit of therapy
Patients will answer a binary assessment of benefit from therapy with Yes or No response options. Yes responses will indicate patients found therapy beneficial whereas No responses will indicate therapy was not found beneficial. Responses will be compared between provider groups.
Secondary outcomes
Change in bothersome visceral bowel symptoms
Patients will complete standardized, validated symptoms questionnaires assessing bowel, bladder, genital, and sexual symptoms and pain features and severity. The Colorectal Functional Outcome questionnaire (COREFO) will assess change in bothersome bowel symptoms, using 27 questions with a score range from 0 to 100. Higher scores will indicate poor function. A score greater than 15 will be considered symptomatic. Results of this questionnaire will be compared between providers.
Change in bothersome visceral bladder symptoms
Patients will complete standardized, validated symptoms questionnaires assessing bowel, bladder, genital, and sexual symptoms and pain features and severity. The International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ - FLUTS) will assess change in bothersome bladder urinary symptoms, using 24 questions with a score range from 0 to 48. Higher scores indicate poor bladder function. Questionnaire responses will be compared between providers.
Change in bothersome visceral sexual symptoms
Patients will complete 19 questions from the female sexual functional index (FSFI) with each question having a Likert scale of 0 (No sexual activity) to 5 (almost always or always) to measure sexual function. Scores may range from 0-36. Higher scores will indicate positive outcomes. Questionnaire responses will be compared between providers.
Change in bothersome visceral genital symptoms
Patients will complete 8 questions from Vulvar and Vaginal Assessment scales (VuAS and VAS) to measure genital symptoms with scale from 0 (no symptoms) to 3 (severe symptoms). Total scores may range between 0-24. Higher scores will be associated with worse outcomes. Patient responses will be compared between provider groups.
Other outcomes
Short-term durability of symptomatic improvements
As an exploratory outcome, the investigators will assess the short-term durability of symptomatic improvements following treatment interventions by reassessing questionnaires from the first 10 previous outcomes 3 months later. Patient responses immediately after treatment will be compared to responses 3 months after treatment using the same questionnaires as in the first 10 outcomes.
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