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.

Analgesia Using Transcutaneous Electric Nerve Stimulation in Office Bladder Chemodenervation, a Randomized Controlled Trial.

IMPORTANCE: Office bladder chemodenervation, performed via cystoscopy with intradetrusor onabotulinumtoxinA (BOTOX) injections, is a common treatment for overactive bladder/urge urinary incontinence. Transcutaneous electric nerve stimulation (TENS) has shown to provide analgesia during office hysteroscopy. Adjuvant analgesia using TENS during bladder chemodenervation has not been studied. OBJECTIVE: The primary outcome is a clinically significant (10-mm) difference in pain visual analog scale (VAS) measurements during injections for chemodenervation using active TENS compared with placebo TENS. We hypothesize that active TENS use will significantly change pain VAS scores. Secondary outcomes include 5-point pain Likert scale, satisfaction 10-point scale, and adverse events. STUDY DESIGN: This was a double-blind randomized control trial of men and women with urinary urge incontinence undergoing office chemodenervation performed in an academic and private setting. Participants were randomized into 2 groups: chemodenervation with active TENS or placebo TENS. Power calculation determined 100 patients would be required detect a difference of 10 mm on pain VAS. RESULTS: One hundred one (85 female and 16 male) participants were recruited. No differences were noted in the demographics. Participants in the active TENS group reported a difference of greater than 10 mm in pain VAS scores (48 ± 23 vs 31 ± 23, P = 0.01). Satisfaction index scores were high but no difference was noted between groups (8.6 vs 8.7, P = 0.68). CONCLUSIONS: Most participants were eligible to use TENS units. Transcutaneous electric nerve stimulation is a safe and noninvasive adjuvant analgesia option for patients undergoing this procedure. Lower pain levels and high satisfaction rates suggest that this is an additional analgesic option during outpatient chemodenervation.

Vaginectomy in Transmasculine Patients: A Review of Techniques in an Emerging Field.

PURPOSE: This report reviews the various techniques for vaginal obliterative surgery in the transmasculine patient population, including advantages and drawbacks with differing methods and reflects on the focus of future research and surgical efforts. FINDINGS: Existing techniques for vaginal obliterative surgery by vaginectomy or colpocleisis vary without strong evidence to identify a superior approach. SUMMARY: The increasing number of transmasculine patients seeking vaginectomy as a part of gender-affirming surgery must be matched by evidence-based techniques that provide a safe, long-term outcome.

Surgical Removal of Midurethral Sling in Women Undergoing Surgery for Presumed Mesh-Related Complications: A Systematic Review.

OBJECTIVE: To assess whether some, or all, of the mesh needs to be removed when a midurethral sling is removed for complications. DATA SOURCES: A systematic review and meta-analysis was conducted. MEDLINE, Cochrane, and ClinicalTrials.gov databases from January 1, 1996, through May 1, 2021, were searched for articles that met the eligibility criteria with total, partial, or a combination of anti-incontinence mesh removal. METHODS OF STUDY SELECTION: All study designs were included (N≥10), and a priori criteria were used for acceptance standards. Studies were extracted for demographics, operative outcomes, and adverse events. Meta-analysis was performed when possible. TABULATION, INTEGRATION, AND RESULTS: We double-screened 11,887 abstracts; 45 eligible and unique studies were identified. Thirty-five were single-group studies that evaluated partial mesh removal, five were single-group studies that evaluated total mesh removal, and five were studies that compared partial mesh removal with total mesh removal. All of the studies were retrospective in nature; there were no randomized controlled studies. Comparative studies demonstrated that partial mesh removal had lower rates of postoperative stress urinary incontinence (SUI) than total mesh removal (odds ratio 0.46, 95% CI 0.22-0.96). Single-group studies supported lower rates of postoperative SUI with partial mesh removal compared with total mesh removal (19.2% [95% CI 13.5-25.7] vs 48.7% [95% CI 31.2-66.4]). Both methods were similar with respect to associated pain, bladder outlet obstruction, mesh erosion or exposure, and lower urinary tract symptoms. Adverse events were infrequent. CONCLUSION: Postoperative SUI may be lower with partial mesh removal compared with total mesh removal. Other outcomes were similar regardless of the amount of mesh removed. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD 42018093099.

Pelvic Floor Organ Prolapse After Radical Cystectomy in Patients With Uroepithelial Carcinoma.

OBJECTIVE: The aim of this study was to identify whether women who undergo a radical cystectomy for uroepithelial carcinoma are at increased risk of pelvic organ prolapse after surgical treatment. METHODS: A retrospective cohort study compared female subjects who had undergone a radical cystectomy for uroepithelial carcinoma, as identified through an institutional cancer survivor database, with subjects who presented to the Pelvic Health and Continence Clinic with symptoms of either uterovaginal prolapse or urinary incontinence. Demographic data were collected regarding risk factors for prolapse, and study subjects were asked to complete a Pelvic Organ Prolapse Distress Inventory (POPDI-6). Data were collected through retrospective chart review. The primary outcome is difference in the POPDI-6 between the groups. Statistical evaluation of responses was performed, with analysis of variance used to compare the questionnaire scores between groups and correction for risk factors with χ2 tests, with a P value of 0.05 selected for statistical significance. RESULTS: There were 36 postcystectomy subjects who responded to the survey, 37 subjects in the prolapse group, and 44 subjects in the incontinence group. With correction for age, body mass index, and number of vaginal deliveries, the postcystectomy group reported significantly lower scores on the POPDI-6 than both the prolapse group (P < 0.0001) and the incontinence group (P = 0.0003). CONCLUSIONS: Radical cystectomy for uroepithelial carcinoma does not correlate with an increased risk of patient-reported symptoms of pelvic organ prolapse.

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.

High-definition ultrasound characterization of acute cyclophosphamide-induced cystitis in the mouse.

Purpose: To examine associations if any between changes in voiding function, hematuria, and bladder ultrasonography metrics in murine cyclophosphamide-induced chemical cystitis. Materials and Methods: Cystitis was induced in 6 female mice by an intraperitoneal injection of cyclophosphamide (300 mg/kg). Voiding frequency, void volume, hematuria assessment, and ultrasonographic measurements of the bladder were obtained at baseline, days 1 to 5, and days 9, 11, and 13. Voiding was induced with preferred sweet drinking solution and voiding data collected using an automated data collection system in 135 minute sessions. Bladder wall thickness, lumen volume, and vascular Doppler were acquired using a high definition ultrasound system. Spearman's correlation was used to analyze the association between the voiding changes, hematuria, and ultrasound findings. Results: Hematuria was present 24 hours after cyclophosphamide injection. All animals displayed increased bladder vascularity, bladder wall thickness, and void frequency that was associated with concurrent decreased total and average void volumes. Increased bladder wall vascularity was correlated with the presence of hematuria (r=0.59, p<0.01) and bladder wall thickness (r=0.79, p<0.01). Hematuria correlated with increased void frequency (r=0.34, p<0.01). Average void volume was negatively correlated with hematuria (r=-0.50, p<0.01) and frequency (r=-0.38, p<0.01). Conclusions: High-definition ultrasound imaging permits in vivo monitoring of changes in bladder morphology associated with voiding function in relation to cyclophosphamide-induced cystitis. Ultrasound imaging of the bladder may assist in differential diagnosis of bladder dysfunction.

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.

Surgical interventions for posterior compartment prolapse and obstructed defecation symptoms: a systematic review with clinical practice recommendations.

INTRODUCTION AND HYPOTHESIS: Several posterior compartment surgical approaches are used to address posterior vaginal wall prolapse and obstructed defecation. We aimed to compare outcomes for both conditions among different surgical approaches. METHODS: A systematic review was performed comparing the impact of surgical interventions in the posterior compartment on prolapse and defecatory symptoms. MEDLINE, Embase, and ClinicalTrials.gov were searched from inception to 4 April 2018. Randomized controlled trials, prospective and retrospective comparative and single-group studies of women undergoing posterior vaginal compartment surgery for vaginal bulge or bowel symptoms were included. Studies had to include both anatomical and symptom outcomes both pre- and post-surgery. RESULTS: Forty-six eligible studies reported on six surgery types. Prolapse and defecatory symptoms improved with native-tissue transvaginal rectocele repair, transanal rectocele repair, and stapled transanal rectocele repair (STARR) surgeries. Although prolapse was improved with sacrocolpoperineopexy, defecatory symptoms worsened. STARR caused high rates of fecal urgency postoperatively, but this symptom typically resolved with time. Site-specific posterior repairs improved prolapse stage and symptoms of obstructed defecation. Compared with the transanal route, native-tissue transvaginal repair resulted in greater improvement in anatomical outcomes, improved obstructed defecation symptoms, and lower chances of rectal injury, but higher rates of dyspareunia. CONCLUSIONS: Surgery in the posterior vaginal compartment typically has a high rate of success for anatomical outcomes, obstructed defecation, and bulge symptoms, although these may not persist over time. Based on this evidence, to improve anatomical and symptomatic outcomes, a native-tissue transvaginal rectocele repair should be preferentially performed.

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.

Anaphylactic Shock After Intravenous Fluorescein Administration for Intraoperative Cystoscopy.

BACKGROUND: Rates of administration of intravenous sodium fluorescein during cystoscopy have increased since indigotindisulfonate sodium was removed from the market in 2014. Although sodium fluorescein has been extensively evaluated and found to be safe, side effects including anaphylaxis have been observed, with an incidence between 0.05% and 1.0%. CASE: We present a case of anaphylactic shock after administration of intravenous sodium fluorescein for the assessment of ureteral efflux in a patient with a history of frequent severe allergic reactions undergoing urethral lysis and cystoscopy for urinary retention. Cardiopulmonary structure and function were evaluated and found to be normal. An elevated serum tryptase level was identified, indicating an anaphylactoid reaction. Timely recognition of symptoms associated with a severe allergic reaction in the setting of hemodynamic instability with prompt supportive and pharmacologic therapy was vital in the patient's recovery. CONCLUSION: Health care providers must be aware of this potential complication, especially in patients with a history of severe allergic reactions.

Barriers to urogynecological care in a population of gynecological oncology patients.

INTRODUCTION AND HYPOTHESIS: The objective was to identify barriers to urogynecological evaluation in a population of new patients presenting to a gynecological oncology practice with symptoms of pelvic floor dysfunction. METHODS: A pelvic floor dysfunction screening questionnaire was given to new patients presenting to a university-based gynecological oncology practice between 1 August 2010 and 31 August 2012. Patients indicating symptoms related to pelvic floor dysfunction in the survey were offered urogynecological evaluations. Charts of those patients declining further evaluation were reviewed. Results of the pelvic floor dysfunction questionnaires were assessed. Reasons provided for not desiring further evaluation were extracted from the questionnaire and stratified. RESULTS: A total of 549 surveys were reviewed. Two hundred and thirty-six patients (42.0 %) of the patients surveyed reported being bothered by pelvic floor dysfunction symptoms. Only 6.7 % (16 out of 236) wanted a referral for an urogynecological evaluation; 93.2 % declined an evaluation. Of patients reporting moderate to severe bother from pelvic floor symptoms, the most frequently cited barrier to care was feeling overwhelmed with the current medical situation (28 %). Other reasons for declining an urogynecological evaluation included a previous evaluation (14 %), financial concerns (6.9 %), and believing that oncological treatment would cure pelvic floor symptoms (6 %). CONCLUSIONS: Quality of life after cancer treatment is important. The ability to provide treatment for gynecological cancer and pelvic floor disorders concomitantly has the potential to improve the quality of life in this patient population. Understanding barriers to care of gynecological oncology patients seeking evaluation for conditions affecting their quality of life is essential in alleviating fears, preventing misconceptions, and for making informed decisions.

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.

Sodium fluorescein use during intraoperative cystoscopy.

BACKGROUND: Indigotindisulfonate sodium has been used during cystoscopy to identify the ureteral meatuses and to verify ureteral efflux during pelvic surgery. The U.S. Food and Drug Administration announced the shortage of indigotindisulfonate sodium in June 2014. Surgeons have since been searching for safe alternatives with comparable visualization and an economically favorable profile. METHOD: The recent shortage of indigotindisulfonate sodium prompted our search for alternative options for visualizing ureteral patency during intraoperative cystoscopy. Multiple methods were considered, including instilling the bladder with D50 water, sterile water, or methylene blue-tinged saline and visualizing the contrast in either viscosity or color of the urine against the instilled medium, preoperative oral phenazopyridine, and intravenous methylene blue. Collectively, these methods proved suboptimal. As an alternative, we injected the 10% preparation of sodium fluorescein at 0.25-1 mL intravenously and observed a brilliant yellow ureteral jet minutes after injection (see Video 1). EXPERIENCE: Ten percent sodium fluorescein given intravenously in doses ranging from 0.25 to 1.0 cc results in good visualization of ureteral jets. One patient experienced transient yellowing of the sclera and palms. CONCLUSION: Sodium fluorescein is an effective alternative to indigotindisulfonate sodium for visualization of ureteral jets during intraoperative cystoscopy.

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.

Promoting physicians' self-assessment and quality improvement: the ABIM diabetes practice improvement module.

INTRODUCTION: The American Board of Internal Medicine (ABIM) recognized that certification and recertification must be based on an assessment of performance in practice as well as an examination of medical knowledge. Physician self-assessment of practice performance is proposed as one method that certification boards may use to evaluate competence in practice-based learning and improvement and systems-based practice. METHODS: Sixteen practicing general internists and endocrinologists with 10-year time-limited certification participated in a beta test of the ABIM's diabetes practice improvement module (PIM) as part of their recertification program. A PIM consists of a self-directed medical record audit, practice system survey, and patient survey. A quality improvement education specialist from the Connecticut Quality Improvement Organization provided on-site and distance consultation on quality improvement methods and tools. An independent audit assessed the reliability of physician self-audit. Qualitative interviews were conducted at 2 time points to assess for physician satisfaction and behavioral change in quality improvement. RESULTS: Fourteen physicians completed the diabetes PIM. All but 1 physician found the medical record audit to provide important information about the practice. Of the 11 physicians who completed a follow-up interview, 10 stated that the quality improvement education specialist helped improve their practice. DISCUSSION: Self-assessment using the ABIM diabetes PIM as part of recertification provides valuable practice information and can lead to meaningful behavioral change by physicians. Collaboration with an educator in quality improvement appears to facilitate the effects of the practice improvement module. Future work should investigate the effect on patient outcomes.