EFFICACY AND SAFETY BETWEENABDOMINAL SACROCOLPOPEXY AND BILATERAL VAGINAL SACROSPINOUS FIXATIONUSING A POLYVINYLIDENE FLUORIDE MESH (DYNAMESH): AN INTERIM ANALYSISOF A RANDOMIZED CONTROLLED TRIAL
E. B. DE CASTRO, L. BRITO, M. V.ROSIQUE, T. A. GOMES, F. RANZANI, C. R. TEATIN-JULIATO;
Gynecologyand Obstetrics, Univ. of Campinas, Campinas, Brazil.
Introduction: Pelvic organprolapse (POP) affects 15-30% of women with more than 50 years andburdens significant expense. Abdominal sacrocolpofixation has beenthe gold standard for apical prolapse when compared to vaginalsacrospinous fixation. However, one of the reasons may be the factthat the anatomical displacement is different when performing thelatter technique in a unilateral fashion; usually the vaginalposterior axis goes to the right or left position, and thus, it mayinfluence the high incidence of cystocele after vaginal vaultfixation. The interposition of a mesh may solve this inconvenienceand modify the efficacy of the vaginal sacrospinous technique, aswell to perform the vaginal sacrospinous fixation in a bilateralfashion.
Objective: To compare the efficacy of a bilateralvaginal sacrospinous fixation with a polyvinylidene fluoride mesh inthe anterior compartment versus abdominal sacrocolpofixation with thesame mesh.
Methods: This is an interim analysis of arandomized controlled trial that was initiated in October 2015.Inclusion criteria were postmenopausal women with advanced POP (stage3 or 4) with no previous gynecological surgery or use of hormonereplacement therapy. POP-Q classification was performed for objectiveassessment before and one year after surgery and the ICIQ-VS, ICIQ-SFand ICIQ-OAB questionnaires were filled out for subjective evaluationof women before surgery and one year after. The vaginal groupunderwent bilateral sacrospinous fixation with anterior defectcorrection with a polyvinylidene fluoride mesh via transobturatorroute and posterior site-specific correction with levator aniapproximation when needed. The abdominal group underwent subtotalhysterectomy with the interposition of the same mesh inanterior/posterior vaginal wall and promontory. Randomization wasperformed by a generated random number sequency, and sealed envelopeswith the allocated group were open minutes before the patient enteredin the operative room. Baseline (sociodemographic andurogynecological symptoms) variables were investigated. Patientimpression related to the surgery was an outcome created:no/partial/total improvement. Intraoperative and postoperativecomplications (bleeding, vaginal discharge, dyspareunia, erosion) andUI relapse were also investigated.
Results: To this moment,45 women were enrolled to participate and two groups were created:abdominal sacrocolpopexy group (n=22) and vaginal sacrospinous group(n=23). No difference was perceived with regard to the baselinevariables: age (p=.87), gravidity (p=.82), vaginal deliveries(p=.70), age at menopause (p=.56), tobacco use (p=.96), stress UI(p=1.0), urge UI (p=.03), constipation (p=.34), pelvic pain (p=.52),presence of sexual intercourse (p=.67), dyspareunia (p=.31). POP-Qmeasurements also did not differ between groups, as well as ICIQ-VS,ICIQ-SF and ICIQ-OAB scores. Apical prolapse stage 3 was higher inthe abdominal group (63.64%) and stage 4 in the vaginal group(65.22%), with no statistical difference (p=.06). Operative time forsacrocolpopexy was seven minutes longer than the sacrospinous group,with no statistical difference (129.68 vs 122.43, p=.10). Spinalanesthesia was more prevalent in the vaginal group (60.87%) andgeneral anesthesia in the abdominal group (54.55%; p<.05). Nostatistical difference between initial and finalhemoglobin/hematocrit was seen in both groups. No difference betweengroups was seen with regard to the number of internship days (p=.55).However, a longer return to daily activities was noticed in theabdominal group (125.18 days vs 63.91 days; p<.05). Both groupshad an improvement in POP-Q measurement points, except for thevaginal lenght measurement. POP-Q measurements did not differ betweengroups after one year, except for the posterior compartment, with abetter correction in the vaginal group (p<.05). Similarly, allquestionnaire scores were improved in both groups and subjectiveimpression improved in both groups (p=.29) with no statisticaldifference between them; fourteen women from the abdominal groupreferred total improvement versus ten women from the vaginal group.Moreover, no statistical difference was seen with regard topostoperative complications between groups; two women presented mesherosion in the vaginal group and only one in the abdominal group(p=.09).
Conclusions: After twelve months of follow-up,abdominal sacrocolpopexy did not differ from vaginal bilateralsacrospinous fixation with regard to objective (ICIQ scores; POP-Qmeasurements except for the posterior compartment) and subjectiveimprovement, as well as postoperative complications. This trial isongoing and further updates will be properly announced.
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