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.

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.

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.

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; chi2 = 25.78, P < .001) and nonmenstrual pelvic pain (VAS score 51 versus 22; chi2 = 16.98, P = .009). In the placebo group only dyspareunia was significantly reduced from baseline (64 versus 27; chi2 = 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; chi2 = 39.53, P < .001), with the placebo group also having lower pelvic floor muscle pressures (44 versus 39; chi2 = 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.

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. AIM: This study aimed to investigate the role of peri-operative physiotherapy in women undergoing corrective surgery for pelvic organ prolapse and/or incontinence. METHODS: In this randomised controlled trial, 30 women underwent preoperative physiotherapy and 30 others had no physiotherapy prior to their incontinence and or prolapse surgeries. Comparison was performed on the basis of the following tests: paper towel test, urinary symptom specific health and quality of life questionnaire, frequency/volume chart and pelvic floor muscle manometry. Women were followed up for 3 months. RESULTS: Both groups showed improvement in urinary continence. Significant group differences were noted in the quality of life questionnaire (P= 0.004), urinary symptoms (P= 0.017) and maximum pelvic floor muscle squeeze on manometry (P= 0.022). Diurnal frequency analysis indicates that there is a significant difference in favour of the treatment group (P= 0.024). CONCLUSION: Routine pre and post operative physiotherapy interventions improve physical outcomes and quality of life in women undergoing corrective surgery for urinary incontinence and or pelvic organ prolapse.

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. DESIGN: A prospective cohort study. SETTING: Outpatient clinic in a tertiary referral centre, Sydney, Australia. SAMPLE: Twelve women, aged 18-55 years, with objective pelvic floor muscle hypertonicity and a minimum 2-year history of chronic pelvic pain were recruited. METHODS: All women completed visual analog scale pain assessments; questionnaires relating to bladder and bowel symptoms and quality of life; and specific examinations. Forty units of BOTOX at three different dilutions were given bilaterally into the puborectalis and pubococcygeus muscles under conscious sedation. RESULTS: Median visual analog scale scores were significantly improved for dyspareunia (80 vs 28; P=0.01) and dysmenorrhea (67 vs 28; P=0.03), with non-significant reductions in non-menstrual pelvic pain (64 vs 37) and dyschesia (47 vs 29). Pelvic floor muscles manometry showed a 37% reduction in resting pressure at week 4 and a 25% reduction was maintained at week 12 (P <0.0001). Quality of life scores (EQ-5D and SF-12) were improved from baseline at week 12, but did not reach statistical significance. Sexual activity scores were markedly improved, with a significant reduction in discomfort (4.8 vs 2.2; P=0.02) and improvement in habit (0.2 vs 1.9; P=0.03). These results were not influenced by dilution. CONCLUSION: There is evidence from the present pilot study suggesting that women with pelvic floor muscles hypertonicity and pelvic pain may respond to BOTOX injections into the pelvic floor muscles. Further research into this novel treatment of chronic pelvic pain is strongly recommended.