Enabling Technologies for Gynecologic Vaginal Surgery: A Systematic Review.

OBJECTIVE: To systematically review the literature to evaluate clinical and surgical outcomes for technologies that facilitate vaginal surgical procedures. DATA SOURCES: We systematically searched MEDLINE, EMBASE, and ClinicalTrials.gov from January 1990 to May 2022. METHODS OF STUDY SELECTION: Comparative and single-arm studies with data on contemporary tools or technologies facilitating intraoperative performance of vaginal gynecologic surgical procedures for benign indications were included. Citations were independently double screened, and eligible full-text articles were extracted by two reviewers. Data collected included study characteristics, technology, patient demographics, and intraoperative and postoperative outcomes. Risk of bias for comparative studies was assessed using established methods, and restricted maximum likelihood model meta-analyses were conducted as indicated. TABULATION, INTEGRATION, AND RESULTS: The search yielded 8,658 abstracts, with 116 eligible studies that evaluated pedicle sealing devices (n=32), nonrobotic and robotic vaginal natural orifice transluminal endoscopic surgery (n=64), suture capture devices (n=17), loop ligatures (n=2), and table-mounted telescopic cameras (n=1). Based on 19 comparative studies, pedicle sealing devices lowered vaginal hysterectomy operative time by 15.9 minutes (95% CI, -23.3 to -85), blood loss by 36.9 mL (95% CI, -56.9 to -17.0), hospital stay by 0.2 days (95% CI, -0.4 to -0.1), and visual analog scale pain scores by 1.4 points on a subjective 10-point scale (95% CI, -1.7 to -1.1). Three nonrandomized comparative studies and 53 single-arm studies supported the feasibility of nonrobotic vaginal natural orifice transluminal endoscopic surgery for hysterectomy, adnexal surgery, pelvic reconstruction, and myomectomy. Data were limited for robotic vaginal natural orifice transluminal endoscopic surgery, suture capture devices, loop ligatures, and table-mounted cameras due to few studies or study heterogeneity. CONCLUSION: Pedicle sealing devices lower operative time and blood loss for vaginal hysterectomy, with modest reductions in hospital stay and pain scores. Although other technologies identified in the literature may have potential to facilitate vaginal surgical procedures and improve outcomes, additional comparative effectiveness research is needed. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42022327490.

Sleep disturbance changes in women after treatment of refractory overactive bladder with sacral neuromodulation.

Purpose: The aim of this study is to evaluate changes in sleep disturbance following treatment of overactive bladder with sacral neuromodulation. Materials and Methods: This is a sub-analysis of data collected from an institutional review board approved retrospective cohort study evaluating women with Patient-Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD) before and after sacral neuromodulation for overactive bladder between March 2016 and October 2017. Data collected included demographics, clinical characteristics, and additional PROMIS item banks. Within-group analysis was performed with paired t-tests. Groups based up on PROMIS-SD improvement (change <0) were then compared using Fisher's exact test, t-test, or Mann-Whitney U-test as appropriate. Results: Those with improved sleep disturbance (n=7) noted a significant mean improvement of -3.99 (95% confidence interval, -6.32, -1.65; p<0.01). Both pre- and post-procedure PROMIS-Physical Function (38.86±2.35 vs. 34.13±5.58, p=0.07 and 37.14±5.10 vs. 35.44±4.74, p=0.53), Pain Interference (60.04±6.34 vs. 65.50±6.20, p=0.13 and 57.89±5.08 vs. 64.73±7.35, p=0.07), Depression (44.2±4.73 vs. 61.29±9.53, p=0.17 and 54.29±6.25 vs. 57.96±11.42, p=0.47) t-scores were similar between sleep response groups. Conclusions: Those with improved sleep disturbance reported significant changes after sacral neuromodulation for overactive bladder. However, no significant differences were identified between those with and without improvement. Further investigation of changes in sleep disturbance and factors affecting change are needed within this population.

Evaluation of Sacral Nerve Stimulation Device Revision and Explantation in a Single Center, Multidisciplinary Study.

OBJECTIVE: This study aimed to determine the incidence and risk factors associated with revision or removal of a sacral nerve stimulation device for treatment of lower urinary tract dysfunction or fecal incontinence. MATERIALS AND METHODS: This is a single-center multidisciplinary retrospective cohort study conducted at a university hospital from January 2013 through October 2017. Subjects who underwent successful sacral neuromodulation were identified via procedural codes. Clinical and demographic data regarding device revision or removal were extracted from the medical record. When testing differences between groups, t-test or Mann-Whitney U test was used to compare continuous variables. Categorical variables were compared by Chi-square test. Risk factors with a p value <0.2 in univariate investigation were included in the multivariate analysis. Logistic regression modeling was used to compare associations between risk factors and re-operation rates. RESULTS: Of the 219 subjects analyzed, 35 (16%) had revision or explantation of the sacral nerve stimulation device. Median time to re-operation was 164 days (interquartile range [IQR]: 29, 525). Subjects with device revised or explanted were younger, with a median age of 50 years vs. 62 years (p < 0.01) for those who did not undergo explantation. Patient demographics and co-morbidities were otherwise similar. Multivariate analysis identified age under 55 years (odds ratio [OR]: 2.51; 95% confidence interval [CI]: 1.18-5.33) as a significant risk factor. Our regression model showed that neither preimplantation diagnosis of chronic pain (OR: 0.60; 95% CI: 0.28-1.27) nor the specialty of the surgeon (OR 1.04; 95% CI 0.66-1.62) was associated with stimulation device revision or explantation. CONCLUSIONS: This study found a 16% incidence of revision or explantation. Age under 55 years was identified as a significant risk factor. Our analysis did not find further demographic characteristics, co-morbid disorders, or behavioral diagnoses that were associated with revision or removal. Identification of risk factors may aid in patient selection for sacral nerve stimulation device implantation.

Do anxiety traits predict subjective short-term outcomes following prolapse repair surgery?

BACKGROUND: Studies conducted in orthopedic surgery have suggested that patients with anxiety have less symptomatic improvement following surgery than those without. We hypothesized for this study that patients with anxiety traits experience less symptomatic improvement following pelvic organ prolapse surgery than patients without. METHODS: All patients presenting for prolapse repair surgery were offered enrollment in this prospective cohort study. Prior to surgery, subjects were asked to complete the Spielberger State-Trait Anxiety Inventory and the Pelvic Floor Distress Inventory 20. Subjects were also asked to list up to five goals related to the outcome of surgery for goal-attainment scaling. At the 6-8-week postoperative visit, subjects were asked to repeat the STAI and PFDI questionnaires and respond to the single question tool assessing Patient Global Impression of Improvement. Subjects were also asked to rate on a Visual Assessment Scale how well preoperative goals were met. All three questionnaires were repeated at >12 weeks following surgery. RESULTS: A total of 32 patients with anxiety trait and 58 without were recruited. Preoperatively, the mean STAI-T was 45.0 (± 7.2.) and 27.7 (± 4.9) for subjects with and without anxiety; PFDI 20 scores were 96.1 (± 48.8) and 94.7 (± 57.5), respectively. At 12+ weeks postoperatively, the mean PFDI-20 for subjects with anxiety was 31.3 (± 20.9) and 30.3 (± 27.9) (p = 0.22) for those without. CONCLUSIONS: We did not find the anxiety trait to be a predictor of subjective outcomes following pelvic organ prolapse surgery.

Utility of anterior vaginal wall length measurement in vaginal reconstructive surgery.

INTRODUCTION AND HYPOTHESIS: The pelvic organ prolapse quantification system (POP-Q) is the most commonly used method to quantify the extent of pelvic organ prolapse. However, it does not include assessment of anterior vaginal wall length (AVL). The objectives of this study were to characterize AVL and distance to the sacrospinous ligament (SSL), and to examine associations between total vaginal length (TVL), AVL, body mass index (BMI) and age. METHODS: This was a retrospective chart review of 139 patients with cervix in situ presenting during an 8-month period for initial evaluation to the University of Rochester Medical Center Urogynecology practice. AVL, TVL and distance to the SSL were measured in addition to POP-Q measurements. Age, height, BMI, presenting complaint and prolapse stage were obtained from medical records. Simple linear regression was used to assess the relationship between TVL and AVL. Multivariate regression was used to test independent variables. RESULTS: The mean ± SD TVL, AVL and distance to the SSL were 9.4 ± 1.2 cm, 7.4 ± 0.9 cm and 7.2 ± 0.9 cm, respectively. All three measurements approached a normal distribution. TVL decreased slightly with age. No association was found between vaginal length and BMI or parity. CONCLUSIONS: AVL is a useful measurement that may aid in surgical decision-making. Providers should consider using AVL when planning sacrospinous hysteropexy.

Prevalence of symptomatic pelvic floor disorders among gynecologic oncology patients.

OBJECTIVE: To describe the prevalence of urinary incontinence and pelvic organ prolapse (POP) in patients with gynecologic cancer before cancer treatment. METHODS: A screening questionnaire on pelvic floor dysfunction was administered as part of the baseline health questionnaire to 549 consecutive new patients presenting to a gynecologic oncology practice. Patients were asked whether they felt a bulge from their vagina or experienced loss of urine associated with activity or urge to urinate. The prevalence of urinary incontinence, POP, or both was determined for each malignancy and benign conditions. χ2 analyses and logistic regression were used to assess significance of differences. RESULTS: Among the 347 women with a gynecologic malignancy, 49.9% women had uterine, 21.0% ovarian, and 14.4% cervical cancer. More than half of the patients with cancer reported baseline urinary incontinence (UI) and 10.9% felt a bulge from their vagina. Approximately 19% of these women had moderate-to-severe symptoms. The prevalence of baseline UI (P=.86) and POP (P=.08) did not differ by gynecologic cancer nor did they differ compared with women with benign gynecologic conditions (UI P=.89, POP P=.20). Logistic regression demonstrated an association between incontinence symptoms and increased age and body mass index (BMI). CONCLUSIONS: Women with gynecologic cancer show high prevalence of symptomatic POP and UI. Age and BMI are risk factors for UI. Coordinated surgical intervention to address both the malignancy and pelvic floor dysfunction could be considered in select patients to enhance postoperative quality of life and to reduce the economic and quality-of-life costs of multiple surgeries. LEVEL OF EVIDENCE: II.