High-tone Pelvic Floor Dysfunction Research Articles

A Treatment Algorithm for High-Tone Pelvic Floor Dysfunction.

A Treatment Algorithm for High-Tone Pelvic Floor Dysfunction.

A Treatment Algorithm for High-Tone Pelvic Floor Dysfunction

A Treatment Algorithm for High-Tone Pelvic Floor Dysfunction

A Treatment Algorithm for High-Tone Pelvic Floor Dysfunction.

To develop evidence- and consensus-based clinical practice guidelines for management of high-tone pelvic floor dysfunction (HTPFD). High-tone pelvic floor dysfunction is a neuromuscular disorder of the pelvic floor characterized by non-relaxing pelvic floor muscles, resulting in lower urinary tract and defecatory symptoms, sexual dysfunction, and pelvic pain. Despite affecting 80% of women with chronic pelvic pain, there are no uniformly accepted guidelines to direct the management of these patients. A Delphi method of consensus development was used, comprising three survey rounds administered anonymously via web-based platform (Qualtrics XM) to national experts in the field of HTPFD recruited through targeted invitation between September and December 2021. Eleven experts participated with backgrounds in urology, urogynecology, minimally invasive gynecology, and pelvic floor physical therapy (PFPT) participated. Panelists were asked to rate their agreement with rated evidence-based statements regarding HTPFD treatment. Statements reaching consensus were used to generate a consensus treatment algorithm. A total of 31 statements were reviewed by group members at the first Delphi round with 10 statements reaching consensus. 28 statements were reposed in the second round with 17 reaching consensus. The putative algorithm met clinical consensus in the third round. There was universal agreement for PFPT as first-line treatment for HTPFD. If satisfactory symptom improvement is reached with PFPT, the patient can be discharged with a home exercise program. If no improvement after PFPT, second-line options include trigger or tender point injections, vaginal muscle relaxants, and cognitive behavioral therapy, all of which can also be used in conjunction with PFPT. Onabotulinumtoxin A injections should be used as third line with symptom assessment after 2-4 weeks. There was universal agreement that sacral neuromodulation is fourth-line intervention. The largest identified barrier to care for these patients is access to PFPT. For patients who cannot access PFPT, experts recommend at-home, guided pelvic floor relaxation, self-massage with vaginal wands, and virtual PFPT visits. A stepwise approach to the treatment of HTPFD is recommended, with patients often necessitating multiple lines of treatment either sequentially or in conjunction. However, PFPT should be offered first line.

Objective Changes in Pelvic Floor Muscle Strength and Length in Women With High-Tone Pelvic Floor Dysfunction After Pelvic Floor Physical Therapy (RELAX Trial)

(Abstracted from Urogynecology 2023;29:872–879) High-tone pelvic floor dysfunction (HTPFD) can cause chronic pelvic pain and lower urinary tract symptoms and can significantly impact quality of life. One treatment for HTPFD is pelvic floor physical therapy (PFPT) that focuses on myofascial treatment; recent studies have shown this to be an effective way to reduce symptoms and improve quality of life.

Triangulation of a Needs Assessment on High-Tone Pelvic Floor Dysfunction.

High-tone pelvic floor dysfunction is a complex condition that is challenging to manage effectively. Pelvic floor physical therapy (PFPT) is often used in the treatment and relies on a coordinated effort between the physician, patient, and physical therapist. Collaboration is crucial for therapy success, but there is limited research that includes personal perspectives from these individuals. The objective of this qualitative study was to gain further insight from these groups to identify areas for improvement in patient counseling and understanding of the diagnosis of high-tone pelvic floor dysfunction and the role of physical therapy. The following participants were recruited: urogynecologists, pelvic floor physical therapists, and patients. Semistructured interviews were conducted exploring participant experiences with therapy and management of the condition and surrounding phenomena. Participants interviewed included 5 urogynecologists, 5 pelvic floor physical therapists, and 15 patients. Similarities in key themes were identified: (1) the usefulness of pelvic models and illustrations in counseling, (2) appropriate descriptions of therapy, (3) motivating factors for patients, and (4) patient barriers to completing therapy. Several emergent themes revealed a misalignment in perspectives, including (1) patients reporting an unclear understanding of PFPT, (2) patient unawareness of the intimacy of therapy, and (3) reports of unsupportive and unempathetic physician providers. There are both similarities and discrepancies in the perspectives among physicians, pelvic floor physical therapists, and patients regarding high-tone pelvic floor dysfunction and PFPT. Acknowledging these comparisons and adapting practices could facilitate patient-centered care and improve patient understanding of their diagnosis.

Osteopathic Manipulative Treatment of Chronic Pelvic Pain due to High-Tone Pelvic Floor Dysfunction

Context: Chronic pelvic pain syndrome (CPPS) is a complex pain syndrome that affects 15%–30% of people of childbearing age (~10–20 million, US). Etiologies range from musculoskeletal conditions and visceral disease to neurological and psychological disorders. The interplay of many systems and disorders can manifest into a complex pathophysiology that is difficult to diagnose and treat. Dysfunction of the musculoskeletal system is often involved in patients with CPPS, either as the cause of pain or the result of underlying disease or dysfunction. Hypertonicity of pelvic floor muscles, myofascial trigger points, and dysfunctional shortening of the levator ani group of muscles contribute to the structural and functional abnormalities involved in CPPS. Osteopathic physicians are in a unique position to directly address this somatic dysfunction with a nonpharmacologic, nonsurgical approach: osteopathic manipulative treatment (OMT).Objectives: The purpose of this article is to review the literature on manual treatment efficacy for high-tone pelvic floor dysfunction (HTPFD) and the standardization of diagnosis to provide rational, medically based treatments. The second purpose is to elucidate the steps that the medical, and specifically the osteopathic profession can take to standardize pelvic floor evaluation, diagnosis, and treatment in the primary care setting.
 Methods: A search was conducted on the US National Library of Medicine’s PubMed database for studies involving manual therapy treatment for HTPFD. The authors excluded studies that described manual therapy interventions aimed at increasing pelvic floor muscle tone in patients with urinary incontinence and/or pelvic organ prolapse.Results: For perspective, the initial search using the keywords “chronic pelvic pain syndrome” led to 2,281 publications since 1974; the addition of “osteopathic” led to 10 results since 2009. The search for “high-tone pelvic floor dysfunction” led to 30 publications since 1992; the addition of “osteopathic” yielded no results. To evaluate the efficacy of manual therapy for HTPFD, the search was expanded to include any manual therapy protocols. While the consensus in the literature is that manual treatment for chronic pelvic pain (CPP) is efficacious, the finding is limited by the lack of a comprehensive protocol to appropriately diagnose and treat the patient. The authors propose a system to standardize the assessment of a patient with CPP in the primary care setting by an appropriately trained physician so that pelvic floor dysfunction is recognized, properly diagnosed and treated, or referred to specialized care.Conclusion: The literature supports that manual therapy is an effective treatment for CPP, and as primary care providers, osteopathic physicians are uniquely placed to recognize and treat patients with HTPFD, providing an empathetic, patient-centered approach. Standardization of the diagnosis and manual treatment of HTPFD is required to assess and monitor patients systematically. Development of an advanced training program for clinicians to learn diagnostic approaches and OMTfor the pelvic floor should be required since the techniques addressing the pelvic floor musculature are often not included in traditional training.

(106) Hormonally-Mediated Vestibulodynia: A Chart Review

Abstract Introduction The borders of the vestibule are Hart’s line laterally, hymen medially, frenulum of the clitoris anteriorly, and fourchette posteriorly. Provoked vestibulodynia (PVD) is characterized by severe burning pain in response to pressure localized to the vestibule. Numerous factors may negatively affect the vestibule causing PVD such as hormonal changes, infections, trauma, exaggerated immunologic or inflammatory responses, dermatologic conditions, high-tone pelvic floor dysfunction, pudendal neuropathy, and sacral radiculopathy. PVD specifically associated with hormonal changes in pre-menopausal women has been termed hormonally mediated vestibulodynia (HMV). Dense labeling of androgen receptors has been noted in the germinal layer of the vestibular epithelium and mucinous minor vestibular glands, implying a critical role of testosterone in vestibular health. Low calculated free testosterone caused by elevated sex hormone binding globulin (SHBG) in pre-menopausal women using combined hormonal contraception may thus be harmful to the vestibular epithelium and minor vestibular glands, resulting in HMV. In HMV, vulvoscopy shows diffuse vestibular tenderness of the entire vestibule, the ostia of the minor vestibular glands are frequently erythematous (Fig 1) and blood testing is consistent with a low calculated free testosterone. Objective We describe the variation in etiologies for HMV and emphasize the importance of measuring total testosterone and SHBG to monitor calculated free testosterone levels in patients with HMV. Methods This is a retrospective chart review of premenopausal patients presenting to a clinic with entrance dyspareunia who were diagnosed with HMV, and whose symptoms were alleviated by treatment. Inclusion criteria were as follows: premenopausal females with initial testosterone and SHBG blood values below the reference range, initial vulvoscopy findings significant for vestibulodynia, follow-up testosterone and SHBG approaching the reference range, and follow-up vulvoscopies demonstrating a relief from symptoms. Results A total of 9 patients met the inclusion criteria. The mean age was 32 years old, with a range of 22 years old to 39 years old. Presenting complaints in addition to dyspareunia (n=9) included recurrent irritative bladder voiding symptoms without positive urine culture (n=3) and pelvic pain (n=4). Vulvoscopic examination including cotton-tipped swab testing of the vestibule revealed signs of vestibular hypersensitivity with pain ranging from 1 to 9 in all 7 regions of the vestibule tested. Patients had histories of having taken combined hormonal contraceptives (n=6), isotretinoin (n=1), spironolactone (n=1) and/or hormonal treatment for breast cancer (n=1), all of which can decrease calculated free testosterone. All patients were treated with systemic testosterone and compounded estradiol/testosterone cream to be applied daily to the vestibule. On follow-up blood testing, all patients had calculated free testosterone values approaching 0.6-0.8 ng/dl, established by Guay et al. as the optimum range. All patients reported significantly decreased dyspareunia and significant relief of other bothersome symptoms, especially bladder symptoms. Conclusions This chart review illustrates a variety of etiologies associated with low calculated free testosterone and the diagnosis of HMV. This data emphasizes the importance of calculating free testosterone and performing vulvoscopy to establish a diagnosis in pre-menopausal patients with entrance dyspareunia. Additionally, this chart review demonstrates the efficacy of systemic testosterone and local vestibular androgen/estradiol therapies in ameliorating vestibular pain and associated symptoms in patients with HMV. Disclosure No

Objective Changes in Pelvic Floor Muscle Strength and Length in Women With High-Tone Pelvic Floor Dysfunction After Pelvic Floor Physical Therapy (RELAX Trial)

Although pelvic floor physical therapy (PFPT) is effective in treating high-tone pelvic floor dysfunction (HTPFD), data on the mechanism of improvement are limited. This study aimed to compare squeeze intravaginal closure force after 6 weeks of PFPT in women affected by HTPFD and, secondarily, to describe changes in levator dimensions and short-term effects of PFPT on bladder, bowel, and pain symptoms. We conducted a prospective cohort study of patients undergoing 6 sessions of PFPT for the diagnosis of HTPFD. At baseline, we measured intravaginal closure force using an instrumented speculum, levator hiatal dimension using a 3-dimensional endovaginal ultrasonography, and symptom severity using 3 validated questionnaires. Intravaginal closure force and symptoms were reevaluated after the second, fourth, and sixth PFPT sessions, and levator hiatus was reevaluated at the sixth session. Twenty-six women were enrolled and 22 completed 6 sessions and are included in the analysis. Contrary to our hypothesis, mean ± SD vaginal closure force (N) did not demonstrate a significant change (3.27 ± 2.34 vs 3.67 ± 2.02 N, P = 0.18). However, mean levator hiatal area (cm2) increased between visit 1 (13.71 ± 1.77 cm2) and visit 6 (14.43 ± 2.17 cm2, P = 0.05), as did the transverse diameter (3.83 ± 0.03 vs 3.95 ± 0.03 cm, P = 0.04). Survey responses demonstrated significant improvements across all measures of genitourinary symptoms, pain, lower gastrointestinal symptoms and quality-of-life measures after 6 sessions of PFPT. Although the levator hiatal area increased after 6 sessions of PFPT (suggesting muscle lengthening), we were unable to demonstrate that this changed the force generated by pelvic floor muscles as measured by a speculum.

Overactive Bladder Patients With and Without Urgency Incontinence: A Spectrum of One Condition or Different Phenotypes?

ABSTRACT The International Continence Society classifies overactive bladder (OAB) as a storage symptom syndrome characterized by “urgency, with or without urgency urinary incontinence, usually with increased daytime frequency and nocturia.” Although heterogenous in nature, some OAB patients exhibit only frequency and urgency (“OAB-dry”), whereas others exhibit frequency and urgency with urgency incontinence (“OAB-wet”). This study aimed to further explore the unique features of each of these diagnoses via comparison of data for women seeking lower urinary tract symptom (LUTS) care, including data such as physical examination findings, self-reported symptoms, and demographic data. Better understanding of OAB-wet and OAB-dry definitive features may lead to more effective treatment. Through the LURN (Lower Urinary Tract Dysfunction Research Network)—sponsored via the research network NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases)—physical examination, demographic data, and questionnaire data were obtained for women seeking LUTS-based care at 6 centers in the United States. Enrollment entailed categorization of patients into urinary incontinence subtypes, as determined by LURN clinical staff from patient LUTS Tool responses. Subgroups included both OAB-dry and OAB-wet categories, as well as a control LUTS group lacking symptoms. The multicenter data set found 545 LUTS-presenting women, with 84 patients being defined as OAB-wet, 56 patients defined as OAB-dry, and 67 patients defined as the control population. The study population was predominantly White (83%), with mean age of the cohort as 58.8 ± 14.1 years. Demographics did not vary between the categories. The groups experienced very similar symptoms, except OAB-wet patients had urgency incontinence, and OAB-dry reported significantly more bladder pain, incomplete emptying, and straining to urinate. Both OAB groups exhibited identical levels of frequency, nocturnal, urgency, and level of bother. Both OAB groups experienced more bother than controls. However, bother for OAB-wet was directly related to severity of incontinence, and bother for OAB-dry was directly related to pelvic floor tenderness on examination. These results may indicate that the individual conditions hail from divergent etiologies, which contradicts traditional disease concepts. Since OAB-dry patients commonly report sensations of incomplete emptying, bladder pain, and straining to urinate, the authors hypothesized that these symptoms may represent a pelvic floor muscle dysfunction rather than a true bladder pathology. This hypothesis is based on the significant overlap between bladder symptoms of OAB-dry and bladder symptoms in high-tone pelvic floor dysfunction (HTPFD) patients (or those with myofascial pelvic pain). Possible causes were this to be the case might be changes in muscle function leading to alterations in the resting angle of the urethrovesical junction and irritation of the bladder neck or urethra. In addition, neuromuscular dysfunction may lead to symptoms of HTPFD and OAB. Strengths of this study include its large study parameters involving multiple centers across the nation, including all patients seeking care for LUTS. Because most women in the study were White, generalizability of the study to a more diverse patient population is limited. In addition, patient self-reporting of incontinence type lacked simultaneous objective testing. Moreover, significant pelvic pain excluded patients from this cohort, which may have excluded patients with more severe forms of OAB-dry from the study population. Although traditionally grouped and treated together under a larger OAB diagnosis, OAB-wet and OAB-dry have unique symptomatic features, suggesting divergent etiologies. Unique symptoms such as pain, a feeling of incomplete emptying, and straining with urination all suggest pelvic floor myofascial dysfunction for OAB-dry patients. Further examination of a distinct pathophysiology for these 2 groups is warranted.

Methenamine Prophylaxis for Recurrent Urinary Tract Infections in a Tertiary Referral Center

Methenamine hippurate (MH) is a urinary antiseptic, indicated for prophylaxis of recurrent urinary tract infections (UTIs) but with only few and limited studies regarding its efficacy. To help address this knowledge gap we reviewed our experience with MH for UTI prophylaxis, focusing on women with recurrent uncomplicated UTIs. The University of Kentucky electronic health record was queried to identify adults who were prescribed MH from the urology clinic between January 2013 and January 2019. Charts were reviewed to assess patient-reported UTI frequency, demographics and relevant health factors. Treatment success was defined as 0-1 UTI in 6 months or 0-2 UTIs in 1 year. Of 670 patients prescribed MH, 508 did not meet inclusion criteria. The most common reasons for exclusion were complicated UTI, no return visit, treatment nonadherence and insufficient followup time. The primary study population was 162 women with recurrent uncomplicated UTIs: 41 premenopausal and 121 postmenopausal. Success rates with MH were 83% and 77%, respectively. Success rates were not significantly associated with age, diabetes, immune suppression, high-tone pelvic floor dysfunction or (if postmenopausal) vaginal estrogen use. Exploratory study of patients using intermittent catheterization showed success in 20 of 30 patients (67%). MH had high success rates for premenopausal and postmenopausal women with recurrent uncomplicated UTIs. Patients using catheters had lower success rates. Prospective trials would strengthen the evidence to guide decisions for treatment and insurance coverage.

Clinical Pharmacology in Women's Health: Current Status and Opportunities.

Clinical Pharmacology in Women's Health: Current Status and Opportunities.

MP07-17 PELVIC FLOOR CHEMODENERVATION OFFERS BENEFIT TO PATIENTS UNDERGOING PHYSICAL THERAPY FOR HIGH TONE PELVIC FLOOR DYSFUNCTION

INTRODUCTION AND OBJECTIVE: Therapeutic options for the management of painful high-tone pelvic floor dysfunction (HTPFD) are limited. We sought to determine whether the addition of pelvic floor chemodenervation to an established regimen of pelvic floor physical therapy (PFPT) for HTPFD improves patients’ subjective outcomes. METHODS: Subjects were recruited from an FPMRS practice. Inclusion criteria included a 6 month history of PFPT-refractory HTPFD. Exclusion criteria included pregnancy or any contraindication to onabotulinumtoxinA (BTX-A) injection. Pelvic floor BTX-A injections were offered following a standard template at either 50, 100, or 150 units. Following injection, patients continued PFPT and were followed for 12 months. Patient reported outcome measures were assessed with visual analog scale (VAS) pain indices of non-menstrual pelvic pain and dyspareunia, Patient Global Impression of Severity (PGI-S), the Pelvic Floor Distress Inventory (PFDI), and the Female Sexual Function Index (FSFI). The Patient Global Impression of Improvement (PGI-I) was also assessed following intervention. Appropriate statistical analyses were used to compare changes in survey responses over time. RESULTS: Twenty patients were enrolled. Of these, 40, 25, and 35% underwent injection with 50, 100, and 150 u, respectively. The average age was 42.8 years (range: 22-78) and BMI was 24.7 (SD: 6.1), with 90% of the subjects being Caucasian and 55% tolerating vaginal penetration prior to BTX-A injection. PGI-S scores showed significant improvement at 2 weeks through 12 months (baseline: 3.01 vs. 2.0-2.1, p<0.01). VAS rated pelvic pain showed >50% improvement at all follow up points; peak improvement was at 3 months (baseline 4.9 vs. 1.6, p<0.01). VAS rated dyspareunia showed significant improvement at 3 through 12 months following injection (baseline: 6.9 vs 2.2-3.4, p<0.01), and PFDI scores showed significant improvement at 3 through 6 months following injection (baseline: 63.3 vs 26.5-27.8, p=0.038-0.045). No significant changes (favorable or unfavorable) were noted with FSFI results. No major adverse events were documented. CONCLUSIONS: The addition of pelvic floor BTX-A to a PFPT regimen is effective in significantly reducing HTPFD-related pelvic pain and dyspareunia while improving health-related quality of life. Peak efficacy was noted 3 months after injection, and no detriment was seen to existing urinary, defecatory, or other sex-related complaints. Further study is needed, but the addition of pelvic floor BTX-A injection appears to be a promising adjunctive treatment for this clinically-challenging condition. Source of Funding: SUFU Chemodenervation Grant

It Takes a Village: The First 100 Patients Seen in a Multidisciplinary Pelvic Floor Clinic.

This study aimed to assess the characteristics of patients assessed and treated at a multidisciplinary pelvic floor program that includes representatives from multiple specialties. Our goal is to describe the process from triaging patients to the actual collaborative delivery of care. This study examines the factors contributing to the success of our multidisciplinary clinic as evidenced by its ongoing viability. This is a descriptive study retrospectively analyzing a prospectively maintained database that included the first 100 patients seen in the Program for Abdominal and Pelvic Health clinic between December 2017 and October 2018. We examined patient demographics, their concerns, and care plan including diagnostic tests, findings, treatments, referrals, and return visits. The clinic met twice monthly, and the first 100 patients were seen over the course of 10 months. The most common primary symptoms were pelvic pain (45), constipation (30), bladder incontinence (27), bowel incontinence (23), high tone pelvic floor dysfunction (23), and abdominal pain (23); most patients had more than one presenting symptom (76). The most common specialties seen at the first visit to the clinic included gastroenterology (56%), followed by physical medicine and rehabilitation (45%), physical therapy (31%), female pelvic medicine and reconstructive surgery (25%), behavioral health (19%), urology (18%), and colorectal surgery (13%). Eleven patients were entirely new to our hospital system. Most patients had diagnostic tests ordered and performed. A multidisciplinary clinic for abdominal and pelvic health proves a sustainable model for comprehensive treatment for patients with pelvic floor dysfunction, including difficulties with defecation, urination, sexual dysfunction, and pain.

Gynecological associated disorders and management.

Chronic pelvic pain syndrome is complex and involves multiple organ systems. The gynecological aspects of chronic pelvic pain syndrome can be divided into four different areas: intra-abdominal, vaginal, pelvic floor muscles and sexual pain. This article provides an overview of gynecological evaluation in patients with chronic pelvic pain and reviews the most common gynecological diagnoses and their management. An extensive review of the literature including guidelines from the International Continence Society, the European Association of Urology, and the International Association for the Study of Pain was performed. Gynecological evaluation of patients with chronic pelvic pain begins with a thorough history and physical examination. Laboratory tests, imaging studies and diagnostic procedures can be used as adjuncts to make a diagnosis. Treatment modalities include physical therapy, medications, trigger points injections, and surgery. Common gynecological diagnoses of chronic pelvic pain include endometriosis, adenomyosis, vulvodynia, high tone pelvic floor dysfunction, and genitopelvic pain/penetration disorder. Gynecology is one of the many systems that can be associated with chronic pelvic pain. Managing patients with chronic pelvic pain requires a multimodal and multidisciplinary approach.

Barriers to Pelvic Floor Physical Therapy Regarding Treatment of High-Tone Pelvic Floor Dysfunction.

Chronic pelvic pain is a prevalent and debilitating condition with a wide range of etiologies. An estimated 30% to 70% of chronic pelvic cases involve musculoskeletal component pain including high-tone pelvic floor dysfunction (HTPFD). Pelvic floor physical therapy has been shown to be a beneficial treatment for HTPFD, yet many patients do not have access to this treatment. The objective of this study was to identify the barriers preventing patients from following through with the first-line management, physical therapy. Participants with a diagnosis of HTPFD (n = 154) were identified from the list of referrals sent from the obstetrics and gynecology department to an affiliated PFPT center. Participants were contacted and asked to complete a phone survey addressing demographics and perceived barriers to care. Responses were collected in REDCap. Univariate and bivariate analyses were performed using a statistical analysis software. Seventy surveys were completed. The top barriers identified by participants were financial constraints (51.4%), perceived lack of utility (37.1%), time constraints (30.0%), and travel issues (18.6%); 84.4% of participants had 1 or more comorbid pain condition. Whereas 51.4% expressed some level of anxiety regarding the PFPT option, only 9.6% of participants did not start treatment because of fear of treatment. The majority of treatment barriers identified were concrete restraints, with insurance noncoverage and time constraints being the top issues. A fair number of participants expressed anxiety about the treatment or felt they received unclear explanations of the treatment. These are areas in which providers can potentially alleviate some barriers to care.

Botulinum Toxin A Injections Into Pelvic Floor Muscles Under Electromyographic Guidance for Women With Refractory High-Tone Pelvic Floor Dysfunction: A 6-Month Prospective Pilot Study.

High-tone pelvic floor dysfunction (HTPFD) is a debilitating chronic pain disorder for many women with significant impact on their quality of life (QoL). Our objective was to determine the efficacy of electromyography-guided onabotulinumtoxinA (Botox; Allergan, Irvine, Calif) injections in treating patient's perception of pelvic pain and improving QoL measurement scores. This is a prospective pilot open-label study of women with chronic pelvic pain and HTPFD who have failed conventional therapy between January 2011 and August 2013. Botox injections (up to 300 U) were done using needle electromyography guidance, from a transperineal approach, to localize spastic pelvic floor muscles (PFMs). Data were collected at baseline, 4, 8, 12, and 24 weeks after injections. This included demographics; Visual Analog Scale (VAS) scores for pain and dyspareunia; validated questionnaires for symptoms, QoL, and sexual function; Global Response Assessment scale for pelvic pain; digital examination of PFM for tone and tenderness; and vaginal manometry. Side effects were also recorded. Out of 28 women who enrolled in the study, 21 completed the 6-month follow-up and qualified for analysis. The mean (SD) age was 35.1 (9.4) years (range, 22-50 years), and the mean (SD) body mass index was 25 (4.4). Comorbidities included interstitial cystitis/bladder pain syndrome (42.9%) and vulvodynia (66.7%). Overall, 61.9% of subjects reported improvement on Global Response Assessment at 4 weeks and 80.9% at 8, 12, and 24 weeks post injection, compared with baseline. Of the subjects who were sexually active at baseline, 58.8% (10/17), 68.8% (11/16), 80% (12/15), and 83.3% (15/18) reported less dyspareunia at 4, 8, 12, and 24 weeks, respectively. Dyspareunia Visual Analog Scale score significantly improved at weeks 12 (5.6, P = 0.011) and 24 (5.4, P = 0.004) compared with baseline (7.8). Two of the 4 patients who avoided sexual activity at baseline secondary to dyspareunia resumed and tolerated intercourse after Botox. Sexual dysfunction as measured by the Female Sexual Distress Scale significantly improved at 8 weeks (27.6, P = 0.005), 12 weeks (27.9, P = 0.006), and 24 weeks (22.6, P < 0.001) compared with baseline (34.5). The Short-Form 12 Health Survey (SF-12) showed improved QoL in the physical composite score at all post injections visits (42.9, 44, 43.1, and 45.5 vs 40 at baseline; P < 0.05), and in the mental composite score at both 12 and 24 weeks (44.3 and 47.8 vs 38.5, P = 0.012). Vaginal manometry demonstrated significant decrease in resting pressures and in maximum contraction pressures at all follow-up visits (P < 0.05). Digital assessment of PFM (on a scale from 0 to 4) showed decreased tenderness on all visits (mean of 1.9, 1.7, 1.8, 1.9; P < 0.001) compared with baseline (2.8). Reported postinjection adverse effects included worsening of the following preexisting conditions: constipation (28.6%), stress urinary incontinence (4.8%), fecal incontinence (4.8%), and new onset stress urinary incontinence (4.8%). Electromyography-guided Botox injection into PFM could be beneficial for women with refractory HTPFD who have failed conservative therapy.

Intra-vaginal diazepam for high-tone pelvic floor dysfunction: a randomized placebo-controlled trial

Intra-vaginal diazepam suppositories are commonly prescribed as a treatment option for high-tone pelvic floor myalgia. This triple-blinded placebo-controlled randomized trial sought to determine if 10 mg diazepam suppositories improve resting pelvic floor electromyography (EMG) compared with placebo. Women ≥18 years of age with hypertonic pelvic floor muscles on examination, confirmed by resting EMG ≥2.0 microvolts (μv), administered vaginal suppositories containing either diazepam or placebo for 28 consecutive nights. Outcomes included vaginal surface EMG (four measurements), the Female Sexual Function Index (FSFI), the Short Form Health Survey 12 (SF-12), four visual analog scales (VAS), the Patient Global Impression of Severity (PGI-S), and the Patient Global Impression of Improvement (PGI-I). A priori sample size calculation indicated that 7 subjects in each group could detect a 2-μv difference in resting EMG tone with 90% power. Twenty-one subjects were enrolled. The mean age was 36.1 (SD 13.9) years, mean body mass index was 28.56 (SD 9.4), and the majority (85.7%) was Caucasian. When evaluating response to therapy, no difference was seen in any of the resting vaginal EMG assessments at any time point within subjects or between groups, nor was an interaction found. Additionally, no differences were noted in any of the validated questionnaires. When used nightly over 4 weeks, 10 mg of vaginal diazepam was not associated with improvement in resting EMG parameters or subjective outcomes compared with placebo. This suggests such that therapy alone may be insufficient in treating high-tone pelvic floor dysfunction.

Botulinum toxin for conditions of the female pelvis: comment

Dear Editor, We have read with interest the report by El-Khawand and colleagues on use of botulinum toxin for conditions of the female pelvis [1]. The authors describe with a systematic approach the mechanism of action of botulinum toxin and its use in different urogynaecological conditions and pelvic floor disorders. It was of particular interest for us to read about the use of botulinum toxin in high-tone pelvic floor dysfunction (pelvic floor muscles spasm), myalgia or vestibulodynia, as we have used it in selected patients for the same conditions in our unit. There are several studies confirming that the muscle spasm could be relieved by the injection of botulinum toxin type A directly into myofascial trigger points [2], leading to a significant reduction in pelvic floor pain. The disadvantages of this treatment are the need for general anaesthesia and the temporary nature of the effect of botulinum toxin on the muscle, necessitating repeated injections. The authors mention that the aetiology of the condition is uncertain and that diagnosis is made only by history and physical examination. There is some evidence in the literature that pelvic floor dysfunction, spasms and associated pelvic floor pain could be attributed to traumatic childbirth and be the result of pelvic floor muscle damage or denervation [3]. Usually, pelvic floor trauma comprises perineal and anal sphincter damage, but recently levator muscle damage (LAM) has been included in this group [4]. It is well known that LAM trauma, and as a consequence chronic pelvic floor pain, is commonly seen in multiparous women with a history of forceps delivery. With regard to diagnosis, several clinical and imaging techniques are currently used in diagnosing levator muscle injury, such as ultrasound and MRI. We would also like to share our experience of injecting botulinum toxin into myofascial trigger points in the outpatient setting, which makes this method more accessible and especially successful, as patients could directly comment on the painful trigger points, assuming that the procedure is tolerated well. It also reduces the risk by avoiding anaesthetic, and in these times of austerity, improving costeffectiveness. To our knowledge this method has not been described before in the scientific literature in women with pelvic floor disorders.

Botulinum toxin for conditions of the female pelvis

Botulinum toxin has recently been approved by the Food and Drug Administration (FDA) for the treatment of urinary incontinence associated with neurogenic detrusor overactivity. However, it has also been used off-label for a multitude of other conditions in the female pelvis, including urological, gynecological, and colorectal. This article reviews the most recent data regarding its efficacy and safety, and administration techniques for those conditions. A literature review of the most relevant reports published between 1985 and 2012. Urinary incontinence related to neurogenic detrusor overactivity is currently the only approved indication in the female pelvis. Other supported off-label uses include: idiopathic detrusor overactivity, interstitial cystitis/bladder pain syndrome, detrusor sphincter dyssynergia, high-tone pelvic floor dysfunction, anal fissure, anismus, and functional anal pain. Botulinum toxin may effectively and safely be used in many conditions of the female pelvis. More high quality research is needed to better clarify its role in the therapeutic algorithm for those indications.

6-Day Intensive Treatment Protocol for Refractory Chronic Prostatitis/Chronic Pelvic Pain Syndrome Using Myofascial Release and Paradoxical Relaxation Training

Chronic prostatitis/chronic pelvic pain syndrome continues to elude conventional therapy. Evidence supports the concept that phenotypes of pelvic muscular tenderness and psychosocial distress respond to myofascial trigger point release and specific relaxation training. This case series reports long-term outcomes of a 6-day intensive combination of such therapies in refractory cases. A total of 200 men with pain for a median of 4.8 years referred themselves to Stanford University Urology for participation in an established protocol. Daily 3 to 5-hour sessions including intrapelvic/extrapelvic physiotherapy, self-treatment training and paradoxical relaxation training provided a solid introduction to facilitate self-management. Subjects answered baseline and followup questionnaires at variable intervals after initiation of therapy including the National Institutes of Health Chronic Prostatitis Symptom Index, global response assessment and a psychological query. We followed 116 men for a median of 6 months. Baseline total symptom index was 26 out of a maximum 43 points. Scores decreased by 30% (p <0.001) at followup with 60% of subjects demonstrating a 6-point or greater decrease (range 6 to 30). Domains of pain, urinary dysfunction and quality of life showed significant improvement (p <0.001). Global response assessment revealed that 82% of subjects reported improvement (59% marked to moderate, 23% slight). Men with chronic pelvic pain refractory to traditional treatment benefit from intensive myofascial trigger point therapy and concomitant paradoxical relaxation training. Education in techniques for self-administered trigger point release and continued pelvic muscle relaxation help patients reduce pain and dysfunction. Refinement of clinical phenotyping and selection of patients with pelvic muscle tenderness should enhance the success rate with this treatment modality.