Marie Fidela R. Paraiso

Laparoscopic compared with robotic sacrocolpopexy for vaginal prolapse: a randomized controlled trial.

OBJECTIVE: To compare conventional laparoscopic and robotic-assisted laparoscopic sacrocolpopexy for vaginal apex prolapse. METHODS: This single-center, blinded randomized trial included participants with stage 2–4 posthysterectomy vaginal prolapse. Participants were randomized to laparoscopic or robotic sacrocolpopexy. The primary outcome was total operative time from incision to closure. Secondary outcomes were postoperative pain, functional activity, bowel and bladder symptoms, quality of life, anatomic vaginal support, and cost from a health care system perspective. RESULTS: A total of 78 patients enrolled and were randomized (laparoscopic n=38; robotic n=40). Total operative time was significantly longer in the robotic group compared with the laparoscopic group (+67-minute difference; 95% confidence interval [CI] 43–89; P<.001). Anesthesia time, total time in the operating room, total sacrocolpopexy time, and total suturing time were all significantly longer in the robotic group. Participants in the robotic group also had significantly higher pain at rest and with activity during weeks 3 through 5 after surgery and required longer use of nonsteroidal anti-inflammatory drugs (median, 20 compared with 11 days, P<.005). The robotic group incurred greater cost than the laparoscopic group (mean difference +

Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: A randomized controlled trial

1,936; 95% CI

Prospective randomized clinical trial of laparoscopically assisted vaginal hysterectomy versus total abdominal hysterectomy.

417–

Laparoscopic Burch colposuspension versus tension-free vaginal tape: A randomized trial

3,454; P=.008). Both groups demonstrated significant improvement in vaginal support and functional outcomes 1 year after surgery with no differences between groups. CONCLUSION: Robotic-assisted sacrocolpopexy results in longer operating time and increased pain and cost compared with the conventional laparoscopic approach. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00551993. LEVEL OF EVIDENCE: I

Anticholinergic therapy vs. onabotulinumtoxinA for urgency urinary incontinence

OBJECTIVE: To compare the safety and efficacy of the transobturator tape to tension-free vaginal tape (TVT) in the treatment of stress urinary incontinence in patients with and without concurrent pelvic organ prolapse. METHODS: One-hundred seventy women with urodynamic stress incontinence, including those with and those without pelvic organ prolapse, from three academic medical centers were randomized to receive TVT or transobturator tape. Subjects with detrusor overactivity or previous sling surgery were excluded. The primary outcome was the presence or absence of abnormal bladder function, a composite outcome defined as the presence of any the following: incontinence symptoms of any type, a positive cough stress test, or retreatment for stress incontinence or postoperative urinary retention assessed 1 year after surgery. This study is a noninferiority study design. RESULTS: Of 180 women who enrolled in the study, 170 underwent surgery and 168 returned for follow-up, with a mean follow-up of 18.2±6 months. Mean operating time, length of stay, and postoperative pain scores were similar between the two groups. Bladder perforations occurred more frequently in the TVT group (7% compared with 0%, P=.02); otherwise, the incidence of perioperative complications was similar. Abnormal bladder function occurred in 46.6% of TVT patients and 42.7% of transobturator tape patients, with a mean absolute difference of 3.9% favoring transobturator tape (95% confidence interval –11.0% to 18.6%.). The P value for the one-sided noninferiority test was .006, indicating that transobturator tape was not inferior to TVT. CONCLUSION: The transobturator tape is not inferior to TVT for the treatment of stress urinary incontinence and results in fewer bladder perforations. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00475839 LEVEL OF EVIDENCE: I

Biologic grafts and synthetic meshes in pelvic reconstructive surgery.

OBJECTIVE We compared operative time, length of hospital stay, postoperative recovery, return to work, and costs for women undergoing laparoscopically assisted vaginal hysterectomy or abdominal hysterectomy. STUDY DESIGN A prospective randomized clinical trial of laparoscopically assisted vaginal hysterectomy (n = 24) versus abdominal hysterectomy (n = 24) was carried out in a tertiary care setting. The main outcome variables were operative time, length of hospital stay, and return to work. Secondary outcomes were postoperative pain and return to normal activity as determined by weekly visual analog scales and daily diary. Hospital costs were calculated. RESULTS The laparoscopically assisted vaginal hysterectomy group had longer operative times (median and quartiles, laparoscopically assisted vaginal hysterectomy 180 [139, 225] minutes vs abdominal hysterectomy 130 [97, 155] minutes), lower requirements for postoperative intravenous analgesia (patient-controlled analgesia pump, median and quartiles: laparoscopically assisted vaginal hysterectomy 22.1 [15.9, 23.5] hours, abdominal hysterectomy 36.7 [26.2, 45.0] hours), shorter length of hospital stay (median and quartiles, laparoscopically assisted vaginal hysterectomy 1.5 [1.0, 2.3] days, abdominal hysterectomy 2.5 [1.5, 2.5] days), and quicker return to work (Kaplan-Meier analysis, P =.03). Both procedures had similar hospital costs (P =.21). CONCLUSION Laparoscopically assisted vaginal hysterectomy appears to allow patients a more rapid postoperative recovery and an earlier return to work with hospital costs similar to those of abdominal hysterectomy.

A randomized trial comparing conventional and robotically assisted total laparoscopic hysterectomy

OBJECTIVE: To compare the laparoscopic Burch colposuspension with the tension-free vaginal tape procedure (TVT) for efficacy. METHODS: Seventy-two women from 2 institutions were randomized: 36 to laparoscopic Burch colposuspension and 36 to TVT. Multichannel urodynamic tests were performed preoperatively and 1 year after surgery. A research nurse administered the Urogenital Distress Inventory, Incontinence Impact Questionnaire, and pelvic examinations using the pelvic organ prolapse quantification system preoperatively, and at 6 months, 1 year, and 2 years after surgery. Voiding diaries were collected at 1 and 2 years. Primary outcome was objective cure, which was defined as no evidence of urinary leakage during postoperative urodynamic studies. Secondary outcomes included subjective continence, perioperative and postoperative data, and quality of life. RESULTS: Thirty-three laparoscopic Burch colposuspension and 33 TVT patients were analyzed with a mean follow-up of 20.6 ± 8 months (range 12–43). Mean operative time was significantly greater in the laparoscopic Burch colposuspension group compared with the TVT group, 132 versus 79 minutes, respectively (P = .003). Multichannel urodynamic studies in 32 laparoscopic Burch colposuspension and 31 TVT patients showed a higher rate of urodynamic stress incontinence at 1 year in the laparoscopic Burch colposuspension group, 18.8% versus 3.2% (P = .056). There was a significant improvement in the number of incontinent episodes per week and in Urogenital Distress Inventory and Incontinence Impact Questionnaire scores in both groups at 1 and 2 years after surgery (P < .001). However, postoperative subjective symptoms of incontinence (stress, urge, and any urinary incontinence) were reported significantly more often in the laparoscopic Burch colposuspension group than in the TVT group (P < .04 for each category). CONCLUSION: The TVT procedure results in greater objective and subjective cure rates for urodynamic stress incontinence than does laparoscopic Burch colposuspension. LEVEL OF EVIDENCE: I

A Comprehensive Review of Suburethral Sling Procedure Complications

BACKGROUND Anticholinergic medications and onabotulinumtoxinA are used to treat urgency urinary incontinence, but data directly comparing the two types of therapy are needed. METHODS We performed a double-blind, double-placebo-controlled, randomized trial involving women with idiopathic urgency urinary incontinence who had five or more episodes of urgency urinary incontinence per 3-day period, as recorded in a diary. For a 6-month period, participants were randomly assigned to daily oral anticholinergic medication (solifenacin, 5 mg initially, with possible escalation to 10 mg and, if necessary, subsequent switch to trospium XR, 60 mg) plus one intradetrusor injection of saline or one intradetrusor injection of 100 U of onabotulinumtoxinA plus daily oral placebo. The primary outcome was the reduction from baseline in mean episodes of urgency urinary incontinence per day over the 6-month period, as recorded in 3-day diaries submitted monthly. Secondary outcomes included complete resolution of urgency urinary incontinence, quality of life, use of catheters, and adverse events. RESULTS Of 249 women who underwent randomization, 247 were treated, and 241 had data available for the primary outcome analyses. The mean reduction in episodes of urgency urinary incontinence per day over the course of 6 months, from a baseline average of 5.0 per day, was 3.4 in the anticholinergic group and 3.3 in the onabotulinumtoxinA group (P=0.81). Complete resolution of urgency urinary incontinence was reported by 13% and 27% of the women, respectively (P=0.003). Quality of life improved in both groups, without significant between-group differences. The anticholinergic group had a higher rate of dry mouth (46% vs. 31%, P=0.02) but lower rates of catheter use at 2 months (0% vs. 5%, P=0.01) and urinary tract infections (13% vs. 33%, P<0.001). CONCLUSIONS Oral anticholinergic therapy and onabotulinumtoxinA by injection were associated with similar reductions in the frequency of daily episodes of urgency urinary incontinence. The group receiving onabotulinumtoxinA was less likely to have dry mouth and more likely to have complete resolution of urgency urinary incontinence but had higher rates of transient urinary retention and urinary tract infections. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Womens Health; ClinicalTrials.gov number, NCT01166438.).

Early experience with mesh excision for adverse outcomes after transvaginal mesh placement using prolapse kits

Despite the lack of evidence, augmenting pelvic organ prolapse surgery with biologic graft or synthetic mesh is increasing. The objective of this review is to examine the available grafts and meshes and discuss the current data addressing the use of these implants in correction of apical, anterior, and posterior prolapse. Most of the studies are retrospective with few randomized controlled trials. There is level I evidence suggesting that repair of apical prolapse with abdominal sacral colpopexy using synthetic mesh results in improved outcomes. However, most of the data concerning graft or mesh incorporation in anterior or posterior repairs do not support augmentation with prosthesis.

The relationship of tension-free vaginal tape insertion and the vascular anatomy.

OBJECTIVE The purpose of this study was to compare operative time and intra- and postoperative complications between total laparoscopic hysterectomy and robotic-assisted total laparoscopic hysterectomy. STUDY DESIGN This study was a blinded, prospective randomized controlled trial conducted at 2 institutions. Subjects consisted of women who planned laparoscopic hysterectomy for benign indications. Preoperative randomization to total laparoscopic hysterectomy or robotic-assisted total laparoscopic hysterectomy was stratified by surgeon and uterine size (> or ≤12 weeks). Validated questionnaires, activity assessment scales, and visual analogue scales were administered at baseline and during follow-up evaluation. RESULTS Sixty-two women gave consent and were enrolled and randomly assigned; 53 women underwent surgery (laparoscopic, 27 women; robot-assisted, 26 women). There were no demographic differences between groups. Compared with laparoscopic hysterectomy, total case time (skin incision to skin closure) was significantly longer in the robot-assisted group (mean difference, +77 minutes; 95% confidence interval, 33-121; P < .001] as was total operating room time (entry into operating room to exit; mean difference, +72 minutes; 95% confidence interval, 14-130; P = .016). Mean docking time was 6 ± 4 minutes. There were no significant differences between groups in estimated blood loss, pre- and postoperative hematocrit change, and length of stay. There were very few complications, with no difference in individual complication types or total complications between groups. Postoperative pain and return to daily activities were no different between groups. CONCLUSION Although laparoscopic and robotic-assisted hysterectomies are safe approaches to hysterectomy, robotic-assisted hysterectomy requires a significantly longer operative time.