Sherin K. Jarvis

Botulinum toxin type A for chronic pain and pelvic floor spasm in women: a randomized controlled trial.

OBJECTIVE: To estimate whether botulinum toxin type A is more effective than placebo at reducing pain and pelvic floor pressure in women with chronic pelvic pain and pelvic floor muscle spasm. METHODS: This study was a double-blinded, randomized, placebo-controlled trial. All participants presented with chronic pelvic pain of more than 2 years duration and evidence of pelvic floor muscle spasm. Thirty women had 80 units of botulinum toxin type A injected into the pelvic floor muscles, and 30 women received saline. Dysmenorrhea, dyspareunia, dyschezia, and nonmenstrual pelvic pain were assessed by visual analog scale (VAS) at baseline and then monthly for 6 months. Pelvic floor pressures were measured by vaginal manometry. RESULTS: There was significant change from baseline in the botulinum toxin type A group for dyspareunia (VAS score 66 versus 12; χ2=25.78, P<.001) and nonmenstrual pelvic pain (VAS score 51 versus 22; χ2=16.98, P=.009). In the placebo group only dyspareunia was significantly reduced from baseline (64 versus 27; χ2=2.98, P=.043). There was a significant reduction in pelvic floor pressure (centimeters of H2O) in the botulinum toxin type A group from baseline (49 versus 32; χ2=39.53, P<.001), with the placebo group also having lower pelvic floor muscle pressures (44 versus 39; χ2=19.85, P=.003). CONCLUSION: Objective reduction of pelvic floor spasm reduces some types of pelvic pain. Botulinum toxin type A reduces pressure in the pelvic floor muscles more than placebo. Botulinum toxin type A may be a useful agent in women with pelvic floor muscle spasm and chronic pelvic pain who do not respond to conservative physical therapy. Clinical Trial Registration: Australian Clinical Trials Registry, http://www.actr.org.au/, ACTRN012605000515695 LEVEL OF EVIDENCE: I

Pilot study of botulinum toxin type A in the treatment of chronic pelvic pain associated with spasm of the levator ani muscles

Objective:  To investigate whether botulinum toxin type A (BOTOX) injected into the levator ani muscles of women with objective pelvic floor muscle spasm decreases pain symptoms and improves quality of life.

The Assessment of Levator Muscle Strength: A Validation of Three Ultrasound Techniques

Abstract: Levator ani muscle function is traditionally evaluated by palpation or perioneometry. Recently, three different techniques of performing this task by translabial ultrasound have been described. The authors intended to validate these new methods by correlating results with assessments performed by perineometry and palpation. One hundred consecutive women were evaluated prospectively by a physiotherapist and a gynecologist. The physiotherapist undertook an assessment by palpation (Oxford grading) and perineometry (PeritronTM). The gynecologist performed translabial ultrasound. Both were blinded against each other’s results. Correlations between ultrasound and palpation were between 0.52 and 0.62, with displacement of the bladder neck agreeing most closely with palpation. As regards perineometry, correlations were 0.38 to 0.52, and again bladder neck displacement agreed best with the physiotherapeutic assessment. All correlations were highly significant. It appears that the assessment of levator function by ultrasound correlates strongly with vaginal palpation of muscle strength and perineometry.

Peri‐operative physiotherapy improves outcomes for women undergoing incontinence and or prolapse surgery: Results of a randomised controlled trial

Background:  Urinary incontinence and pelvic organ prolapse are common complaints in women. Physiotherapy and surgery to correct these conditions are often seen as mutually exclusive. No study has yet investigated their synergistic potential.

The use of botulinum toxin type A (BOTOX®) as treatment for intractable chronic pelvic pain associated with spasm of the levator ani muscles

In May 1999, a 34 year old woman presented to the pelvic pain diagnosis and treatment unit for assessment of her chronic pelvic pain. Her general health was good, with no history of sexual abuse or significant psychiatric disorder. Her gynaecological history included two caesarean deliveries, a miscarriage and a termination of her most recent pregnancy in 1993 complicated by a uterine perforation, requiring a subtotal hysterectomy. Following the procedure, she continued to have menstrual discharge every month, and significant pelvic pains including dysmenorrhoea (rated 5/10), dyspareunia (10/10), intermenstrual pain (7/10), but no dyschesia. She had no specific treatment for this pain and was managed by simple analgesia. Continued pain led to further evaluation, and a pelvic examination suggested left uterosacral endometriosis and a pelvic ultrasound indicated a probable endometrioma of the left ovary. In July 1999, a laparoscopy for resection of endometriosis and left salpingooophorectomy was performed and the diagnosis confirmed histologically. Following surgery, there was a reduction in dyspareunia (to 2/10) and intermenstrual pain (to 4/10) but a new symptom of severe dyschesia was reported (9/10). A flexible sigmoidoscopy was performed with no evidence of pathology and a second-look laparoscopy was undertaken in December 1999 and fibrotic tissue removed anterior to the rectum. Histologically, there was no residual endometriosis. During 2000, the patient reported worsening dyspareunia and constant non-menstrual pelvic pain. A range of medications was tried including paracetamol, non-steroidal anti-inflammatories, combined oral contraceptives, anxiolytics and antidepressants, with little or no effect. Pelvic examination revealed tenderness and spasm of the puborectalis and pubococcygeus muscles. Pelvic floor muscle manometry (perineometry) readings registered increased pelvic floor muscle resting tone of 48 cm (<30 cm H2O expected). Relaxation techniques and strategies for defecation and coitus were taught. Despite these, the pelvic pain, pelvic floor muscle tenderness and raised perineometry readings continued. In July 2000, the patient was given injections totalling 4 mL Xylocaine 1% (AstraZeneca, UK) to the puborectalis and pubococcygeus muscles bilaterally. This resulted in marked reduction in the pain and allowed easy pelvic examination and a reduction in the resting perineometry reading to 8 cm H2O. The local anaesthetic response was short-lived and within one to two weeks the chronic pelvic pain symptoms returned to pre-injection levels. During 2001, management of the pain symptoms continued with analgesics, anti-inflammatories, anxiolytics, antidepressants, physiotherapy and intermittent local anaesthetic injections to the pelvic floor muscles. The puborectalis and pubococcygeus spasm continued and the patient had significant discomfort with coitus. In June 2002, this patient received injections of botulinum toxin type A (BOTOXR, Allergan, Gordon, NSW, Australia) to the pelvic floor muscles in an attempt to reduce the muscle spasm and tenderness. The injections were performed under conscious sedation using a combination of propofol, midazolam and fentanyl, and were monitored by an anaesthetist. The woman was placed in a lithotomy position and the vulva was swabbed with an antiseptic. The muscles to be injected were located by digital vaginal palpation. The puborectalis was felt as a tight sling around the vagina, just distal from the hymenal ring. The needle was held in a near-horizontal plane, the vaginal mucosa pierced just inside the hymenal ring, within the posterior third of the hymenal opening. To inject the puborectalis muscle, the needle was directed slightly laterally and posteriorly for approximately 5–10 mm. The pubococcygeus has a more coronal angulation and is lateral and posterior to the puborectalis fibres. To inject the pubococcygeus muscles, the operator’s index finger was BJOG: an International Journal of Obstetrics and Gynaecology February 2005, Vol. 112, pp. 247–249

Response to Pudendal Nerve Block in Women with Pudendal Neuralgia

OBJECTIVE To examine the evolution of pain and the duration of numbness after neural blockade of the pudendal nerve in women with pudendal neuralgia and correlate with clinical and historical data. DESIGN Prospective, single arm, open label study. SETTING University hospital and outpatient clinic. SUBJECTS Eighty-two adult female patients were recruited from November 8, 2008 to February 14, 2010. Patients were selected based on the presence of spontaneous or provoked pain in the distribution of the pudendal nerve. INTERVENTIONS Subjects underwent a standardized pudendal nerve block. OUTCOME MEASURES Visual analog pain scores and the presence of numbness were recorded before and for 64 hours after the pudendal nerve block. A complete clinical history and examination were documented. RESULTS Sixty-six patients completed the study. About 86.9% had a reduction in one or more pain symptom, while 44.3% found that more than one of their pain symptoms did not return. About 69.7% of patients reported numbness lasting up to 16 hours or longer. Previous gynecological surgery was recorded in 75.8%, previous traumatic obstetric events in 47.0% of cases. Prolonged history of pain correlated with a reduced chance of positive outcome of the pudendal nerve block. CONCLUSION In patients with pudendal neuralgia, the pudendal nerve block has a variable response, but may have a beneficial effect in a subset of women. Surgical and obstetrical trauma are common historical antecedents.

The Acceptability, Feasibility, and Efficacy (Phase I/II Study) of the OVERcome (Olive Oil, Vaginal Exercise, and MoisturizeR) Intervention to Improve Dyspareunia and Alleviate Sexual Problems in Women with Breast Cancer

INTRODUCTION Almost half of breast cancer survivors experience chronic sexual problems. Despite the negative effects of dyspareunia on physical and overall quality of life, sexual dysfunction remains underreported and undertreated in clinical practice. This is likely due to the paucity of evidence-based interventions to improve sexual functioning. AIM The study aims to prospectively evaluate the acceptability, feasibility, and efficacy of a novel intervention (Olive Oil, Vaginal Exercise, and MoisturizeR [OVERcome]) to improve sexual problems following breast cancer treatment. MAIN OUTCOME MEASURES Dyspareunia, sexual functioning, quality of life, distress, and pelvic floor muscles (PFMs) functioning were evaluated. METHODS Twenty-five women with dyspareunia were instructed to perform pelvic floor muscle (PFM) relaxation exercises twice/day to prevent/manage PFM overactivity, apply a polycarbophil-based vaginal moisturizer three times/week to alleviate vaginal dryness, use olive oil as a lubricant during intercourse, and complete a weekly compliance diary. PFM relaxation training was administered by a physiotherapist at weeks 0 and 4, with follow-up at weeks 12 and 26. At each visit, women completed validated self-report questionnaires and the physiotherapist recorded objective measures of PFM functioning. RESULTS OVERcome resulted in significant improvements in dyspareunia, sexual function, and quality of life over time (all P<0.001). PFM relaxation training was reported to be effective (P≤0.001). Maximum benefits were observed at week 12. Most women rated PFM relaxation exercises (92%), vaginal moisturizer (88%), and olive oil (73%) as helpful, indicating that the intervention was acceptable. Unexpectedly, six cases (11%) of vaginal stenosis were noted during initial screening. CONCLUSIONS This novel intervention is acceptable to patients with demonstrated efficacy in improving dyspareunia and sexual function following breast cancer. Delivery of the OVERcome intervention appears feasible in a clinical setting, providing a potential treatment for this important clinical issue. The unexpected number of observed cases of stenosis further highlights the underreporting of sexual problems in this population, deserving further exploration.

A clinical guide to the management of genitourinary symptoms in breast cancer survivors on endocrine therapy

There is increasing attention and concern about managing the adverse effects of adjuvant endocrine therapy for women with early breast cancer as the side effects of therapy influence compliance and can impair quality of life (QoL). Most side effects associated with tamoxifen (TAM) and aromatase inhibitors (AIs) are directly related to estrogen deprivation, and the symptoms are similar to those experienced during natural menopause but appear to be more severe than that seen in the general population. Prolonged estrogen deprivation may lead to atrophy of the vulva, vagina, lower urinary tract and supporting pelvic structures, resulting in a range of genitourinary symptoms that can in turn lead to pain, discomfort, impairment of sexual function and negatively impact on multiple domains of QoL. The genitourinary side effects may be prevented, reduced and managed in most cases but this requires early recognition and appropriate treatment. We provide an overview of practical clinical approaches to understanding the pathophysiology and the management of genitourinary symptoms in postmenopausal women receiving adjuvant endocrine therapy for breast cancer.

Exploring knowledge, attitudes and experience of genitourinary symptoms in women with early breast cancer on adjuvant endocrine therapy

Clinical trials of adjuvant endocrine therapy in women with early breast cancer have consistently reported that genitourinary symptoms are common. However, little is known about womens experiences of genitourinary symptoms, their views about the symptoms and how they impact on their lives. The aim of this study was to explore knowledge, attitudes and experiences of genitourinary symptoms among women receiving adjuvant endocrine therapy for early breast cancer. Thirty-two semi-structured interviews were conducted and subjected to a rigorous qualitative analysis. Genitourinary symptoms were commonly reported to negatively impact on personal, social and physical activities, were often attributed to anxiety and stress and were a source of embarrassment. Women also commented on the limited information available or provided regarding the potential genitourinary adverse effects of adjuvant endocrine therapy. There was a general lack of awareness that their symptoms could be associated with or exacerbated by adjuvant endocrine therapy. Women indicated a preference to receive information and advice about potential management options from either their general practitioner or specialist. These findings underscore the importance of improving communication and increasing awareness among both clinicians and patients about the potential impact of adjuvant endocrine therapy on genitourinary symptoms.