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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.

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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.

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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.

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