Rapp D.E.,Virginia Urology Center for Incontinence |
King A.B.,Virginia Commonwealth University |
Rowe B.,Virginia Urology Center for Incontinence |
Wolters J.P.,Virginia Commonwealth University
Journal of Urology | Year: 2014
Purpose The Elevate® Anterior and Apical Prolapse Repair System is a polypropylene mesh that is anchored through sacrospinous ligament and obturator fascia fixation points. We present a comprehensive evaluation of this prolapse repair system through 2 years with a focus on safety, operative characteristics, and anatomical, subjective and quality of life outcomes. Materials and Methods A total of 42 women underwent repair of stage II or greater anterior/apical compartment prolapse using the repair system, of whom 2 were lost to followup. Anatomical outcomes were assessed using POP-Q (Pelvic Organ Prolapse Quantification) staging. Subjective and quality of life outcomes were assessed by the validated ICIQ (International Consultation on Incontinence Questionnaire)-VS (Vaginal Symptoms), ICIQ-FLUTS (Female Lower Urinary Tract Symptoms) and IIQ-7 (Incontinence Impact Questionnaire-7). Additional outcomes included a 3-day bladder diary and cough test with outcomes assessed preoperatively, at 6 weeks, and at 1 and 2 years. Results Mean ± SD blood loss was 93 ± 55 cc and mean operative time was 58 ± 27 minutes. POP-Q points Aa, Ba and C improved from 0.9, 0.8 and -1.3 preoperatively to -2.1, -2.7 and -6.1 cm at 2 years, respectively (each p <0.05). Four patients experienced anatomical recurrence, which was associated in 2 with symptomatic recurrence on the ICIQ-VS. Statistically significant improvements in the ICIQ-VS, ICIQ-FLUTS and IIQ-7 were seen throughout followup. Adverse events included leg pain, vaginal exposure and urinary retention in 1, 2 and 5 patients, respectively. Conclusions The Elevate Anterior and Apical Prolapse Repair System was associated with good anatomical restoration and significant improvements in validated symptom and quality of life indexes through 2 years of assessments. Our experience suggests that the system is a safe, effective surgical procedure in appropriately selected patients. Long-term followup is important, given the FDA (Food and Drug Administration) warning regarding the use of surgical mesh in the repair of pelvic organ prolapse.
King A.B.,Virginia Urology Center for Incontinence |
King A.B.,Virginia Commonwealth University |
Wolters J.P.,Virginia Urology Center for Incontinence |
Klausner A.P.,Virginia Urology Center for Incontinence |
Rapp D.E.,Virginia Urology Center for Incontinence
Urology | Year: 2013
Objective: To examine the effect of the tension-free vaginal tape-obturator (TVT-O) on sexual function and vaginal symptoms. The effect of anti-incontinence surgery on vaginal symptoms and sexual function is controversial; these assessments are increasingly important given the Food and Drug Administration warning regarding the use of transvaginal surgical mesh. Materials and Methods: A retrospective review of 42 patients undergoing TVT-O with a minimum 1-year follow-up data was performed. The outcomes were assessed at baseline and 1 year postoperatively using validated questionnaires, including the International Consultation on Incontinence Questionnaire-Vaginal Symptoms, a validated measure assessing the impact of vaginal symptoms and sexual matters on quality of life and treatment outcomes. The International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms and Incontinence Impact Questionnaire, Short Form were used to assess the incontinence and quality of life outcomes, respectively. Results: Statistically significant improvements were seen in the vaginal symptoms (from 9.7 to 6.0, P =.01), sexual matters (from 16.7 to 6.9, P =.01), and quality of life (from 3.0 to 1.1, P =.001) domains on the International Consultation on Incontinence Questionnaire-Vaginal Symptoms from the baseline to 1-year assessment. Of 20 sexually active patients at baseline, 18 reported continued sexual activity postoperatively, with 2 patients reporting an absence of sexual activity because of other factors. Six patients who were not sexually active at baseline because of vaginal symptoms had resumed sexual activity at 1 year. Statistically significant improvement in vaginal soreness and a trend toward improvement in the abdominal pain domain score were seen. Conclusion: TVT-O sling placement was associated with symptom stability or improvement in validated measures of sexual function and vaginal symptoms. These data do not support the concerns regarding worsening sexual function and vaginal symptoms after TVT-O sling placement. © 2013 Elsevier Inc. All Rights Reserved.