Skeletal muscle relaxants for the treatment of myofascial pelvic pain and high tone pelvic floor disorders.

PURPOSE OF REVIEW: Chronic pelvic main is a complex process that includes many causes. In gynecology, the treatment of myofascial pelvic pain and high tone pelvic floor disorders can be managed with skeletal muscle relaxants for select clinical indications. A review of skeletal muscle relaxants will be included for gynecologic indications. RECENT FINDINGS: There are limited studies on vaginal skeletal muscle relaxants, but there can be oral forms used for chronic myofascial pelvic pain. They function as antispastic, antispasmodic, and combination of the two modes of action. Diazepam is the most studied for myofascial pelvic pain in both oral and vaginal formulations. Its use can be combined with multimodal management to optimize outcomes. Other medications have limitations due to dependency and limited studies that demonstrate improvement in pain scales. SUMMARY: Skeletal muscle relaxants have limited high quality studies for chronic myofascial pelvic pain. Their use can be combined with multimodal options to improve clinical outcomes. Additional studies are needed for vaginal preparations and evaluation of safety and clinical efficacy for patient reported outcomes measures in patients living with chronic myofascial pelvic pain.

Injectable recombinant human collagen-derived material with high cell adhesion activity limits adverse remodelling and improves pelvic floor function in pelvic floor dysfunction rats.

Female pelvic floor dysfunction (FPFD) is a life-changing condition that severely affects women's physical and mental health. Despite the effectiveness of current treatments for FPFD, there is a high rate of short-term recurrence. Here, we introduced an injectable recombinant human collagen (rhCOL)-derived material with high cell adhesion activity to achieve pelvic floor repair and extracellular matrix (ECM) assembly. In our study, rhCOL promoted human uterosacral ligament fibroblast (HULF) adhesion, migration, and collagen I and III expression and regulated the metabolism of HULFs in vitro. Subsequently, we established a rat model of FPFD. Then, rhCOL, including rhCOLI and rhCOLIII, was perivaginally injected into FPFD rats, resulting in a significant increase in abdominal urine leak point pressure (LPP) and maximum tensile strength compared to the FPFD model group. Better organization of the lamina propria and muscularis in FPFD rats was observed after 14 days of rhCOL treatment. Meanwhile, the expression of collagen I, collagen III, and TIMP1 was upregulated, and MMP2 was downregulated. Furthermore, rhCOL promoted HULF adhesion, migration, and ECM synthesis by upregulating the focal adhesion kinase (FAK)/RhoA/ROCK signalling pathway in vitro and in vivo. These findings suggest that the perivaginal injection of rhCOL is a promising treatment for FPFD with potential for future clinical use.

A Systematic Review of Intravaginal Diazepam for the Treatment of Pelvic Floor Hypertonic Disorder.

This systematic review evaluates the efficacy of intravaginal diazepam in treating chronic pelvic pain and sexual dysfunction associated with high-tone pelvic floor dysfunction. A literature search was conducted in Medline and Web of Science, including articles from the database's inception to July 2019. The search identified 126 articles, and 5 articles met study inclusion criteria: 2 observational reviews and 3 small randomized, controlled trials (RCTs) evaluating intravaginal diazepam for high-tone pelvic floor dysfunction. The 2 observational studies identified subjective reports of improvement in sexual function for a majority of women, 96% and 71%, in each study. However, there were no statistical differences between Female Sexual Function Index (FSFI) and Visual Analog Scale (VAS) scores for pain identified. One RCT found no significant changes between groups in median FSFI or VAS scores, and a second RCT found no significant changes between groups in 100-mm VAS scores. The third RCT demonstrated that compared with placebo, treatment with transcutaneous electrical nerve stimulation and intravaginal diazepam for women with vestibulodynia and high-tone pelvic floor dysfunction yielded significant differences in reduction of dyspareunia (P ≤ .05), ability to relax pelvic floor muscles after contraction (P ≤.05), and current perception threshold values at a 5-Hz stimulation related to C fibers (P < .05), but no significant changes in 10-cm VAS scores. Intravaginal diazepam may be helpful in women with a specific diagnosis of high-tone pelvic floor dysfunction, but more and larger studies are needed to confirm these potential effects.

Vaginal Diazepam for Nonrelaxing Pelvic Floor Dysfunction: The Pharmacokinetic Profile.

BACKGROUND: Vaginal diazepam is frequently used to treat pelvic floor tension myalgia and pelvic pain despite limited knowledge of systemic absorption. AIM: To determine the pharmacokinetic and adverse event profile of diazepam vaginal suppositories. METHODS: We used a prospective pharmacokinetic design with repeated assessments of diazepam levels. Eight healthy volunteers were administered a 10-mg compounded vaginal diazepam suppository in the outpatient gynecologic clinic. Serum samples were collected at 0, 45, 90, 120, and 180 minutes; 8, 24, and 72 hours; and 1 week following administration of a 10-mg vaginal suppository. The occurrence of adverse events was assessed using the alternate step and tandem walk tests, the Brief Confusion Assessment Method, and numerical ratings. Plasma concentrations of diazepam and active long-acting metabolites were measured. Pharmacokinetic parameters were calculated by standard noncompartmental methods. RESULTS: The mean peak diazepam concentration (Cmax) of 31.0 ng/mL was detected at a mean time (Tmax) of 3.1 hours after suppository placement. The bioavailability was found to be 70.5%, and the mean terminal elimination half-life was 82 hours. The plasma levels of temazepam and nordiazepam peaked at 0.8 ng/mL at 29 hours and 6.4 ng/mL at 132 hours, respectively. Fatigue was reported by 3 of 8 participants. CLINICAL IMPLICATIONS: Serum plasma concentrations of vaginally administered diazepam are low; however the half-life is prolonged. STRENGTHS & LIMITATIONS: Strengths include use of inclusion and exclusion criteria aimed at mitigating clinical factors that could adversely impact diazepam absorption and metabolism, and the use of an ultrasensitive LC-MS/MS assay. Limitations included the lack of addressing the efficacy of vaginal diazepam in lieu of performing a pure pharmacokinetic study with healthy participants. CONCLUSION: Vaginal administration of diazepam results in lower peak serum plasma concentration, longer time to peak concentration, and lower bioavailability than standard oral use. Providers should be aware that with diazepam's long half-life, accumulating levels would occur with chronic daily doses, and steady-state levels would not be reached for up to 1 week. This profile would favor intermittent use to allow participation in physical therapy and intimacy. Larish AM, Dickson RR, Kudgus RA, et al. Vaginal Diazepam for Nonrelaxing Pelvic Floor Dysfunction: The Pharmacokinetic Profile. J Sex Med 2019;16;763-766.

[Use of botulinum toxin A in pelvic floor dysfunctions in the elderly: A review]. / Intérêt de la toxine botulinique A dans le traitement des troubles pelvi-périnéaux de la personne âgée.

INTRODUCTION: The present article is the final report of a multi-disciplinary meeting supported by the GRAPPPA (group for research applied to pelvic floor dysfunctions in the elderly). The objective was to conduct a comprehensive review on the role of botulinum toxin A (BonTA) in the treatment of pelvic floor dysfunctions in the elderly. METHODS: The present article, written as a comprehensive review of the literature, combines data issued from the scientific literature with expert's opinions. Review of the literature was performed using the online bibliographic database MedLine (National Library of Medicine). Regarding intra-detrusor BonTA injections, only articles focusing on elderly patients (>65 yo) were included. Regarding other localizations, given the limited number of data, all articles reporting outcomes of BonTA were included, regardless of studies population age. In case of missing or insufficient data, expert's opinions were formulated. RESULTS: Although, available data are lacking in this specific population, it appears that BonTA could be used in the non-fraily elderly patients to treat overactive bladder or even neurogenic detrusor overactivity, with a success rate comparable to younger population at 3 months (88.9% vs. 91.2%), 6 months (49.4% vs. 52.1%) and 12 months (23.1% vs. 22.3%), as well as a significant decrease in number of voids per day (11.4 vs. 5.29 P<0.001) and in the number of pads per day (4.0 vs. 1.3, P<0.01). Furthermore, BonTA is likely to be offered in the future as a treatment of fecal incontinence and obstructed defecation syndrome symptoms. Concerning bladder outlet obstruction/voiding dysfunction symptoms, intra-urethral sphincter BonTA should not be recommended. CONCLUSION: BonTA injections are of interest in the management of various pelvic floor dysfunctions in the elderly, and its various applications should be better evaluated in this specific population in order to further determine its safety and efficacy.

Intravaginal Diazepam for the Treatment of Pelvic Floor Hypertonic Disorder: A Double-Blind, Randomized, Placebo-Controlled Trial.

OBJECTIVES: Pelvic floor hypertonic disorder is characterized by an involuntary spasm of the levator ani muscles and is associated with several clinical syndromes. Several treatment options have been described; however, treatment efficacy data are limited. The objective of this study was to determine the efficacy of intravaginal diazepam for the treatment of pelvic pain secondary to levator ani muscle spasm in comparison to placebo. METHODS: Adult women with complaints of pelvic pain, who were noted to have levator ani muscle spasm on physical examination, were approached for enrollment in a double-blind, placebo-controlled, randomized clinical trial. Eligible participants were randomized to receive 10-mg diazepam capsules or identical-appearing placebo capsules. The primary outcome was the change in pain scores measured by a 100-mm visual analog scale at 4 weeks. Several validated questionnaires were similarly assessed as secondary outcomes. RESULTS: In total, 49 women were randomized (25 in the diazepam arm and 24 in the placebo arm). At 4 weeks, 35 women returned for follow-up and had complete data available analysis. There was no difference in visual analog scale scores between the treatment groups after 4 weeks (50 vs 39 mm, for diazepam and placebo, respectively; P = 0.36). There were also no differences noted in the questionnaire scores. CONCLUSIONS: It is unlikely that self-administered intravaginal diazepam suppositories promote an improvement in the 100-mm visual analog scale of 20 mm or more or other substantial symptom improvement in women with pelvic floor hypertonic disorder.

The mysteries of menopause and urogynecologic health: clinical and scientific gaps.

OBJECTIVES: A significant body of knowledge implicates menopausal estrogen levels in the pathogenesis of the common pelvic floor disorders (PFDs). These health conditions substantially decrease quality of life, increase depression, social isolation, caregiver burden, and economic costs to the individuals and society. METHODS: This review summarizes the epidemiology of the individual PFDs with particular attention to the understanding of the relationship between each PFD and menopausal estrogen levels, and the gaps in science and clinical care that affect menopausal women. In addition, we review the epidemiology of recurrent urinary tract infection (rUTI)-a condition experienced frequently and disproportionately by menopausal women and hypothesized to be potentiated by menopausal estrogen levels. RESULTS: The abundance of estrogen receptors in the urogenital tract explains why the natural reduction of endogenous estrogen, the hallmark of menopause, can cause or potentiate PFDs and rUTIs. A substantial body of epidemiological literature suggests an association between menopause, and PFDs and rUTIs; however, the ability to separate this association from age and other comorbid conditions makes it difficult to draw definitive conclusions on the role of menopause alone in the development and/or progression of PFDs. Similarly, the causative link between the decline in endogenous estrogen levels and the pathogenesis of PFDs and rUTIs has not been well-established. CONCLUSIONS: Innovative human studies, focused on the independent effects of menopausal estrogen levels, uncoupled from tissue and cellular senescence, are needed.

Transvaginal Trigger Point Injections Improve Pain Scores in Women with Pelvic Floor Hypertonicity and Pelvic Pain Conditions.

OBJECTIVES: Chronic pelvic pain in women often requires multimodal treatment regimens. We describe our method of transvaginal trigger point injections (TPIs) and report outcomes using change in pain scores. METHODS: This was a retrospective review of women treated with in-office pelvic floor muscle injections from January 2012 to August 2015. Lidocaine 1% and 2%, bupivacaine 0.5%, or ropivacaine 0.5% with or without the addition of triamcinolone 40 mg was used for the injections. Pain was reported on a 0- to 10-point numerical rating scale before and after injection. Differences in pretreatment and posttreatment pain scores were analyzed after the first injection and after subsequent injections. Repeated-measures analysis was used to determine if any variable affected treatment response. RESULTS: One hundred one women with a mean age of 44 years had a total of 257 separate visits for pelvic floor muscle injections. Triamcinolone was used at 90.2% (230/255) of the TPI visits. After the initial TPI visit, there was significant decrease in total levator numerical rating scale score (maximum score, 20; mean, -6.21 ± 4.7; P < 0.0001), and 77% (70/91) of patients had improved. These significant improvements were noted at all visits 1 through 4 and whether bilateral or unilateral injections were done. Only the total amount of local anesthestic used had a significant effect on the change in total levator pain scores (P = 0.002). Minor adverse effects including leg numbness, dizziness, nausea, bleeding, and headache occurred at 10% of visits. CONCLUSIONS: Pelvic floor muscle injections decrease pain levels in women with pelvic floor dysfunction.

Protocolo para tratamento de prolapso de órgãos pélvicos com pessário vaginal / Protocolo de tratamiento del prolapso de órganos pélvicos con pesario vaginal / Protocol for pelvic organ prolapse treatment with vaginal pessaries

Resumo Objetivo Desenvolver um protocolo clínico para o tratamento conservador do prolapso de órgãos pélvicos com pessário vaginal. Métodos Pesquisa de desenvolvimento ocorrida de julho de 2015 a janeiro de 2016 e realizada em etapas: refinamento dos tópicos/questões do protocolo; estabelecimento de recomendações para pesquisa e atualização; revisão por pares. A análise se deu por programa estatístico e pelo Índice de Validade de Conteúdo. Resultados O protocolo foi desenvolvido e avaliado por meio da técnica Delphi quanto aos critérios objetivos, conteúdo e apresentação e relevância por profissionais da área, sendo calculado o Índice de Validade de Conteúdo total de cada domínio e global. O Índice de Validade de Conteúdo total do domínio objetivos foi 1,00, do critério conteúdo e apresentação foi 0,98 e do domínio relevância, 0,96. Obteve-se o Índice de Validade de Conteúdo global de 0,98. Dessa forma, verificou-se concordância entre os participantes da técnica Delphi, com valor acima de 0,85, considerando o protocolo clínico válido. Conclusão Acredita-se que os profissionais de saúde, ao utilizar o protocolo clínico, terão maior embasamento na prática, oferecendo um cuidado de maior qualidade, pois é uma ferramenta válida e pautada cientificamente.

Resumen Objetivo Desarrollar un protocolo clínico para el tratamiento conservador del prolapso de órganos pélvicos con pesario vaginal. Métodos Investigación de desarrollo realizada entre julio de 2015 y enero de 2016, efectuada en etapas: refinación de tópicos/preguntas del protocolo; establecimiento de recomendaciones para investigación y actualización; revisión por pares. Análisis ejecutado mediante programa estadístico e Índice de Validez de Contenido. Resultados El protocolo fue desarrollado y evaluado utilizándose la técnica Delphi respecto a los criterios objetivos, contenido y presentación, y relevancia por profesionales del área, calculándose el Índice de Validez de Contenido total de cada dominio y el global. El Índice de Validez de Contenido total del dominio objetivos fue 1,00; el del criterio contenido y presentación, del 0,98; y el del dominio relevancia, 0,96. El Índice de Validez de Contenido global fue de 0,98. Así, se verificó concordancia de la técnica Delphi entre los participantes, con valor superior a 0,85; considerándose válido el protocolo clínico. Conclusión Al ser utilizado por los profesionales de salud, el protocolo clínico les brindará mayor fundamentación en la práctica, permitiéndoles ofrecer mejor calidad de atención, pues es una herramienta válida y elaborada científicamente.

Abstract Objective To develop a clinical protocol for the conservative treatment of pelvic organ prolapse with vaginal pessaries. Methods Developmental research conducted in the period from July 2015 to January 2016 and performed in the following steps: refinement of topics/protocol issues; establishing recommendations for research and updates; peer review. The analysis was by statistical program and the Content Validity Index (CVI). Results The protocol was developed and evaluated by professionals of the area through the Delphi technique regarding criteria of objectives, content and presentation, and relevance. The total CVI of each domain and the overall CVI were calculated. The total Content Validity Index for the objectives domain was 1.00, for content and presentation criterion was 0.98, and for the relevance domain was 0.96. The overall Content Validity Index obtained was 0.98. Thus, there was agreement among participants of the Delphi technique with value above 0.85, and the clinical protocol was considered valid. Conclusion When health professionals use the clinical protocol, they will have a better foundation in practice and offer a higher quality care, since this is a valid and scientifically based tool.

A Review of Phytoestrogens and Their Association With Pelvic Floor Conditions.

INTRODUCTION: Urinary incontinence, pelvic organ prolapse, and fecal incontinence are pelvic floor disorders (PFDs) disproportionately experienced by postmenopausal women. Limited data exist suggesting that phytoestrogens may have an impact on the pathophysiology and symptom of PFDs. PURPOSE OF REVIEW: The aim of the study was to review the current literature addressing the role of phytoestrogens on PFDs, including the pathophysiology, symptom, treatment, and possible prevention. FINDINGS: Qualifying literature spans from 2003 to 2017 and included 14 studies ranging from in vitro, animal, and observational studies to randomized clinical trials. SUMMARY: Although the literature is limited, most studies on phytoestrogens and PFDs support associations with pathophysiologic mechanisms, symptoms, and treatment for urinary incontinence and pelvic organ prolapse, but not fecal incontinence. Less is known regarding the prevention of PFDs with phytoestrogen intake over time. Overall, the potential influence of phytoestrogens on PFDs is not well understood, and more research is needed.

Botulinum toxin to treat pelvic pain.

Botulinum toxin's (BoNT) success in treating several pain disorders has triggered interest in its application for pelvic pain disorders. This article summarizes results presented at the recent Neurotoxins Meeting in Madrid, Spain, in January 2017. It does not include BoNT use for Interstitial Cystitis/Bladder Pain Syndrome, which was the topic of a separate lecture. It includes studies documenting the beneficial effects of OnaBoNTA for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) in men using both transrectal and transurethral injection techniques. It also focuses on research using OnaBoNTA to treat levator spasms in women with chronic pelvic pain. Finally, it presents a novel approach using high density quantitative surface EMG to map out innervation zones and allow for more precise targeting of hypertonic pelvic floor muscles.

The role of local estrogen therapy in the management of pelvic floor disorders.

Pelvic floor disorders are common and bothersome problems that include a variety of conditions. These conditions greatly affect the performance of daily activities and social function such as work, traveling, physical exercise, sleep and sexual function. Aging is a well-known factor affecting the pelvic floor and lower urinary tract anatomy and function. It is clear that the pelvic organs and their surrounding muscular and connective tissue support are estrogen-responsive. Treatment of pelvic floor disorders requires significant health-care resources and their impact is likely to increase in the near future. This literature review aims to provide an overview of both research and clinical aspects of the pathophysiology of urogenital estrogen deficiency and the role of local estrogen therapy as part of the management strategy of different pelvic floor disorders. The safety and risk concerns regarding the use of local estrogen therapy are addressed as well.

Local Oestrogen for Pelvic Floor Disorders: A Systematic Review.

OBJECTIVE: The decline in available oestrogen after menopause is a possible etiological factor in pelvic floor disorders like vaginal atrophy (VA), urinary incontinence (UI), overactive bladder (OAB) and pelvic organ prolapse (POP). This systematic review will examine the evidence for local oestrogen therapy in the treatment of these pelvic floor disorders. EVIDENCE ACQUISITION: We performed a systematic search in MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and the non-MEDLINE subset of PubMed from inception to May 2014. We searched for local oestrogens and VA (I), UI/OAB (II) and POP (III). Part I was combined with broad methodological filters for randomized controlled trials (RCTs) and secondary evidence. For part I and II two reviewers independently selected RCTs evaluating the effect of topical oestrogens on symptoms and signs of VA and UI/OAB. In part III all studies of topical oestrogen therapy in the treatment of POP were selected. Data extraction and the assessment of risk of bias using the Cochrane Risk of Bias Tool was undertaken independently by two reviewers. EVIDENCE SYNTHESIS: The included studies varied in ways of topical application, types of oestrogen, dosage and treatment durations. Objective and subjective outcomes were assessed by a variety of measures. Overall, subjective and urodynamic outcomes, vaginal maturation and vaginal pH changed in favor of vaginal oestrogens compared to placebo. No obvious differences between different application methods were revealed. Low doses already seemed to have a beneficial effect. Studies evaluating the effect of topical oestrogen in women with POP are scarce and mainly assessed symptoms and signs associated with VA instead of POP symptoms. CONCLUSION: Topical oestrogen administration is effective for the treatment of VA and seems to decrease complaints of OAB and UI. The potential for local oestrogens in the prevention as well as treatment of POP needs further research.

Novel Treatment of Chronic Bladder Pain Syndrome and Other Pelvic Pain Disorders by OnabotulinumtoxinA Injection.

Chronic pelvic pain (CPP) is defined as pain in the pelvic organs and related structures of at least 6 months' duration. The pathophysiology of CPP is uncertain, and its treatment presents challenges. Botulinum toxin A (BoNT-A), known for its antinociceptive, anti-inflammatory, and muscle relaxant activity, has been used recently to treat refractory CPP with promising results. In patients with interstitial cystitis/bladder pain syndrome, most studies suggest intravesical BoNT-A injection reduces bladder pain and increases bladder capacity. Repeated BoNT-A injection is also effective and reduces inflammation in the bladder. Intraprostatic BoNT-A injection could significantly improve prostate pain and urinary frequency in the patients with chronic prostatitis/chronic pelvic pain syndrome. Animal studies also suggest BoNT-A injection in the prostate decreases inflammation in the prostate. Patients with CPP due to pelvic muscle pain and spasm also benefit from localized BoNT-A injections. BoNT-A injection in the pelvic floor muscle improves dyspareunia and decreases pelvic floor pressure. Preliminary studies show intravesical BoNT-A injection is useful in inflammatory bladder diseases such as chemical cystitis, radiation cystitis, and ketamine related cystitis. Dysuria is the most common adverse effect after BoNT-A injection. Very few patients develop acute urinary retention after treatment.

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.

OBJECTIVES: 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. METHODS: 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. RESULTS: 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%). CONCLUSIONS: Electromyography-guided Botox injection into PFM could be beneficial for women with refractory HTPFD who have failed conservative therapy.

Vaginal estrogen use in postmenopausal women with pelvic floor disorders: systematic review and practice guidelines.

INTRODUCTION AND HYPOTHESIS: Risk of pelvic floor disorders increases after menopause and may be linked to estrogen deficiency. We aimed to systematically and critically assess the literature on vaginal estrogen in the management of pelvic floor disorders in postmenopausal women and provide evidence-based clinical practice guidelines. METHODS: MEDLINE and Cochrane databases were searched from inception to July 2014 for randomized controlled trials of commercially available vaginal estrogen products compared with placebo, no treatment, or any medication for overactive bladder or urinary incontinence. We double-screened 1,805 abstracts and identified 12 eligible papers. Studies were extracted for participant information, intervention, comparator, efficacy outcomes, and adverse events, and they were individually and collectively assessed for methodological quality and strength of evidence. RESULTS: Evidence was generally of poor to moderate quality. Vaginal estrogen application before pelvic organ prolapse surgery improved the vaginal maturation index and increased vaginal epithelial thickness. Postoperative vaginal estrogen use after a midurethral sling resulted in decreased urinary frequency and urgency. Vaginal estrogen and immediate-release oxybutynin were similar in improvement of urinary urgency, frequency, and urgency urinary incontinence in women with overactive bladder, but oxybutynin had higher rates of side effects and discontinuation. Conversely, the addition of vaginal estrogen to immediate or extended-release tolterodine did not improve urinary symptoms more than tolterodine alone. One study reported an improvement in stress urinary incontinence with use of vaginal estrogen. CONCLUSION: Vaginal estrogen application may play a useful role as an adjunct in the management of common pelvic floor disorders in postmenopausal women.

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

INTRODUCTION AND HYPOTHESIS: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

INTRODUCTION AND HYPOTHESIS: 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. METHODS: A literature review of the most relevant reports published between 1985 and 2012. RESULTS: 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. CONCLUSIONS: 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.