Are there age-related changes in the measurements of the urethral sphincter complex in nulliparous women? A three-dimensional ultrasound assessment.

INTRODUCTION AND HYPOTHESIS: The objective was to determine age-related changes in measurements of urethral sphincter complex components in asymptomatic nulliparous women. METHODS: Eighty nulliparous women ≥18 years underwent 3D ultrasound of the anterior pelvic compartment in a cross-sectional study. Measurements of the urethral sphincter components (smooth muscle sphincter [SMS] and striated urinary sphincter [SUS]) and urethra including area, length, width, and distance of the SUS and SMS from the urethrovesical junction were obtained. The women were grouped into four age groups: < 30 years (group A), 30 to < 45 (group B), 45 to < 60 (group C), and ≥ 60 years (group D). Age-related differences in the measurements were determined. Inter-rater and intra-rater agreement were performed for 20 nulliparous women. RESULTS: There were 24, 18, 26, and 12 women in groups A, B, C, and D respectively. None of the urethral sphincter complex measurements was significantly associated with age (p > 0.05). No differences were found between the groups for any measurements using one-way ANOVA and multiple comparison pairwise comparison (p > 0.05) other than width of SMS (C > A), urethral length (C > A), and distance of SUS from urethrovesical junction (C > D). Inter-rater and intra-rater agreement were moderate for area, length, and width of SUS (intraclass correlation 0.6) and good (intraclass correlation above 0.8) for the remaining measurements. CONCLUSION: Other than width of SMS, urethral length, and distance of SUS from urethrovesical junction, the dimensions of urethral sphincter complex components, as visualized by 3D endovaginal ultrasound, do not vary with age.

Referral pattern for vaginal mesh and graft complications to the University of Oklahoma Pelvic and Bladder Health Clinic.

OBJECTIVE: To evaluate the referral pattern to a tertiary care center for vaginal mesh complications following surgeries for pelvic organ support defect. METHODS: This was a retrospective review of women presenting to our clinic for complications of vaginal mesh. RESULTS: One hundred thirty three patients were included in the study. The median age was 58.4 years, median parity was two, and 95.4% were Caucasian. The pattern of referral was as follows: 10% continued care at the tertiary center where mesh or graft was initially inserted, 18% were referred by the surgeon who initially implanted the mesh or graft, 71% were referred from an outside secondary health care provider, and 1% was self referred. CONCLUSION: The majority of patients presenting to our clinic with mesh vaginal mesh complications were referred by someone other than the implanting surgeon.

Infection rates in a large investigational trial of sacral nerve stimulation for fecal incontinence.

INTRODUCTION: Treatment options for patients with fecal incontinence (FI) are limited, and surgical treatments can be associated with high rates of infection and other complications. One treatment, sacral nerve stimulation (SNS), is approved for FI in Europe. A large multicenter trial was conducted in North America and Australia to assess the efficacy of SNS in patients with chronic fecal incontinence. The aim of this report was to analyze the infectious complication rates in that trial. METHODS: Adult patients with a history of chronic fecal incontinence were enrolled into this study. Those patients who fulfilled study inclusion/exclusion criteria and demonstrated greater than two FI episodes per week underwent a 2-week test phase of SNS. Patients who showed a > or = 50% reduction in incontinent episodes and/or days per week underwent chronic stimulator implantation. Adverse events were reported to the sponsor by investigators at each study site and then coded. All events coded as implant site infection were included in this analysis. RESULTS: One hundred twenty subjects (92% female, 60.5 +/- 12.5 years old) received a chronically implanted InterStim Therapy device (Medtronic, Minneapolis, MN, USA). Patients were followed for an average of 28 months (range 2.2-69.5). Thirteen of the 120 implanted subjects (10.8%) reported infection after the chronic system implant. One infection spontaneously resolved and five were successfully treated with antibiotics. Seven infections (5.8%) required surgical intervention, with infections in six patients requiring full permanent device explantation. The duration of the test stimulation implant procedure was similar between the infected group (74 min) and the non-infected group (74 min). The average duration of the chronic neurostimulator implant procedure was also similar between the infected (39 min) and non-infected group (37 min). Nine infections occurred within a month of chronic system implant and the remaining four infections occurred more than a year from implantation. While the majority (7/9) of the early infections was successfully treated with observation, antibiotics, or system replacement, all four of the late infections resulted in permanent system explantation. CONCLUSION: SNS for FI resulted in a relatively low infection rate. This finding is especially important because the only other Food and Drug Administration-approved treatment for end-stage FI, the artificial bowel sphincter, reports a much higher rate. Combined with its published high therapeutic success rate, this treatment has a positive risk/benefit profile.

Sacral nerve stimulation for fecal incontinence: results of a 120-patient prospective multicenter study.

BACKGROUND: Sacral nerve stimulation has been approved for use in treating urinary incontinence in the United States since 1997, and in Europe for both urinary and fecal incontinence (FI) since 1994. The purpose of this study was to determine the safety and efficacy of sacral nerve stimulation in a large population under the rigors of Food and Drug Administration-approved investigational protocol. METHODS: Candidates for SNS who provided informed consent were enrolled in this Institutional Review Board-approved multicentered prospective trial. Patients showing > or =50% improvement during test stimulation received chronic implantation of the InterStim Therapy (Medtronic; Minneapolis, MN). The primary efficacy objective was to demonstrate that > or =50% of subjects would achieve therapeutic success, defined as > or =50% reduction of incontinent episodes per week at 12 months compared with baseline. RESULTS: A total of 133 patients underwent test stimulation with a 90% success rate, and 120 (110 females) of a mean age of 60.5 years and a mean duration of FI of 6.8 years received chronic implantation. Mean follow-up was 28 (range, 2.2-69.5) months. At 12 months, 83% of subjects achieved therapeutic success (95% confidence interval: 74%-90%; P < 0.0001), and 41% achieved 100% continence. Therapeutic success was 85% at 24 months. Incontinent episodes decreased from a mean of 9.4 per week at baseline to 1.9 at 12 months and 2.9 at 2 years. There were no reported unanticipated adverse device effects associated with InterStim Therapy. CONCLUSION: Sacral nerve stimulation using InterStim Therapy is a safe and effective treatment for patients with FI.