Effectiveness and safety of a novel, collapsible pessary for management of pelvic organ prolapse.

BACKGROUND: Pessaries are an effective treatment for pelvic organ prolapse, yet currently available pessaries can cause discomfort during removal and insertion. An early feasibility trial of an investigational, collapsible pessary previously demonstrated mechanical feasibility during a brief 15-minute office trial. Longer-term, patient-centered safety and efficacy data are needed. OBJECTIVE: This study aimed to assess the effectiveness and safety of the investigational vaginal pessary for pelvic organ prolapse at 3 months. STUDY DESIGN: This was a prospective, 7-center, open-label equivalence study with participants serving as their own controls. Subjects were current users of a Gellhorn or ring pessary with ≥stage 2 prolapse. Subjective and objective data were collected at baseline for 1 month while subjects used their current pessary. Data were then collected throughout a 3-month treatment phase with the study pessary. The primary outcome was change in Pelvic Floor Distress Inventory-20 score. Secondary outcome measures included objective assessment of prolapse support, changes in the Pelvic Floor Impact Questionnaire-7, and pain with insertion and removal, measured using a visual analog scale. Data from subjects fitted with the study pessary were analyzed using an intention-to-treat approach, and those who dropped out were assigned scores at the upper limit of the predefined equivalence limits. Secondary per protocol analyses included subjects who completed treatment. The study was powered to 80% with a minimal important change equivalence limit of 18.3 points on the Pelvic Floor Distress Inventory-20 scale. Square root transformations were used for nonparametric data, and P values were adjusted for multiple comparisons. RESULTS: A total of 78 subjects were enrolled, however, 16 withdrew before study pessary placement. The study pessary was fitted in 62 subjects (50 ring and 12 Gellhorn pessary users), and 48 (62%) completed the 3-month intervention. The change in Pelvic Floor Distress Inventory-20 scores at 3 months demonstrated equivalence when compared with the subjects' baseline scores (mean difference, -3.96 [improvement]; 90% confidence interval, -11.99 to 4.08; P=.002). Among those completing study, the Pelvic Floor Distress Inventory-20 scores, equivalence was not demonstrated and scores favored the study pessary (mean difference, -10.45; 90% confidence interval, -20.35 to 0.54; P=.095). Secondary outcomes included objective measures of support, which were similar (mean difference: Ba, 0.54 cm; Bp, 0.04 cm, favoring study pessary; improvement in mean Pelvic Floor Impact Questionnaire-7 scores for those who completed the trial: before, 32.23; after, 16.86; P=.019), and pain with insertion and removal, which was lower with the study pessary than with the subject's own pessary (mean difference visual analog scale score insertion, 9.91 mm; P=.019; removal, 11.23 mm; P=.019). No serious adverse events related to the pessary were reported. CONCLUSION: Equivalence was demonstrated in the primary outcome of the study pessary when compared with current, noncollapsible pessaries in terms of change in severity and bother of pelvic floor symptoms. Among participants who completed the trial, the Pelvic Floor Impact Questionnaire-7 improved with study pessary use and change in Pelvic Floor Distress Inventory-20 scores were nonequivalent, favoring the study pessary. Subjects reported significantly lower pain scores with both pessary insertion and removal with the novel collapsible pessary when compared with their standard pessary.

Introducing New Technologies and Techniques into Gynecologic Surgical Practice.

The surgery practiced today is not the same as the surgery practiced a generation ago and because of the ever-evolving nature of medicine, ongoing education, and adoption of new technology is vital for all surgeons. New technology has the potential to revolutionize the way we practice medicine; however, it is important to understand the context in which new medical devices arise and to approach new medical devices with a healthy combination of skepticism and optimism. Surgeons should feel comfortable assessing, critiquing, and adopting new technology.

Comparing postoperative voiding dysfunction after mid-urethral sling using either a Babcock or Kelly clamp tensioning technique.

INTRODUCTION AND HYPOTHESIS: The objective was to compare postoperative urinary retention using the Babcock and Kelly clamps for retropubic midurethral sling (RPS) tensioning. METHODS: This was a retrospective cohort of isolated RPS procedures from December 2010 through April 2016 by five fellowship-trained surgeons at two institutions. Slings were tensioned with a Babcock clamp by grasping a 3-mm midline fold of mesh (RPS-B) or a Kelly clamp as a spacer between the sling and suburethral tissue (RPS-K). Assessment of urinary retention included the primary outcome of postoperative catheterization and several secondary outcomes, including discharge home with a catheter, within 1 year of surgery. Analysis of covariance was used to compute the mean difference in duration of catheterization and log-binomial regression was used to calculate risk ratios (RR) and 95% confidence intervals (CI). RESULTS: We included 240 patients. The RPS-B group had a lower body mass index and was more likely to be menopausal, have had pelvic organ prolapse surgery, and have a lower maximum urethral closure pressure than the RPS-K group. The mean duration of catheterization was similar, as demonstrated by the crude (0.21 days [-0.30-0.71]) and BMI-adjusted (0.07 days [-0.41-0.55]) mean difference in duration of catheterization. The incidence of postoperative OAB symptoms was comparable between the groups (BMI-adjusted RR: 0.95 (0.80-1.1)), and the incidence of revision did not differ (p = 0.7). CONCLUSIONS: The Babcock and Kelly clamp tensioning techniques appear comparable, with a low incidence of prolonged postoperative catheterization. Most catheters were removed on the day of the surgery. It is reasonable to tension retropubic midurethral slings with either method.

Laparoscopic supracervical hysterectomy with transcervical morcellation and sacrocervicopexy for the treatment of uterine prolapse.

INTRODUCTION AND HYPOTHESIS: The objective is to describe our surgical approach for management of uterine prolapse using 5-mm skin incisions and transcervical morcellation. METHODS: This video presents a novel approach for laparoscopic supracervical hysterectomy, bilateral salpingectomy, and sacrocervicopexy using only 5-mm skin incisions and transcervical morcellation. The procedure begins with a laparoscopic supracervical hysterectomy with bilateral salpingectomy. A classic intrafascial supracervical hysterectomy (CISH) instrument is then used transvaginally to core the endocervical canal. A disposable morcellator is placed through the remaining cervix to morcellate the uterus and fallopian tubes. Following morcellation, the handle of the morcellator is removed, and it is used during the remainder of the surgery as an access cannula for the sacrocervicopexy. The polypropylene mesh is introduced through this cannula. It is secured to the anterior and posterior vaginal fascia with a suture that is also introduced through the transcervical port. At the conclusion of the surgery, a previously placed 0 Vicryl purse-string suture at the ectocervix is tied down as a cerclage around the cervix once the cannula is removed. CONCLUSIONS: The transcervical morcellation technique demonstrated in this video allows the surgeon to maintain 5-mm skin incisions and core the endocervical canal during a laparoscopic supracervical hysterectomy with sacrocervicopexy.

Use of a vessel loop to ensure tunnel patency during LeFort colpocleisis.

INTRODUCTION: The objective was to describe a novel method for maintaining bilateral channel patency for potential uterine drainage during LeFort colpocleisis. METHODS: This video presents a novel approach for ensuring bilateral channel patency during colpocleisis. An 88-year-old gravida 2 para 2 with stage 4 uterovaginal prolapse presented for definitive surgical management. She was no longer sexually active. After counseling on various treatment options, she elected to proceed with a LeFort colpocleisis. During the procedure, the vaginal epithelium is dissected off the underlying tissue with sharp dissection after infiltration with local anesthetic. After the epithelium is removed anteriorly and posteriorly, a blue vessel loop is placed across the cervix and within the lateral channels as they are created with a series of figure of eight stitches. Care is taken to suture around and not through the vessel loop. This is done on both sides. The anterior and posterior dissected surfaces of the vagina are then reapproximated to involute the vagina until the distal epithelial edges can be brought together. Once the vaginal epithelial edges are sewn, the vessel loop is easily pulled through, ensuring channel patency. CONCLUSIONS: The vessel loop technique demonstrated in this video allows the surgeon to ensure that the bilateral channels remain patent throughout the procedure.

Attitudes toward transvaginal mesh among patients in a urogynecology practice.

INTRODUCTION AND HYPOTHESIS: There has been increasing media attention regarding transvaginal mesh (TVM). We hypothesized that new urogynecology patients have limited knowledge and negative opinions of TVM. METHODS: An anonymous survey was distributed to all new patients presenting to the Mt Auburn Hospital urogynecology practice from 1 November 2012 to 31 January 2013. A total of 146 patients completed the questionnaire. The survey was designed to elicit information on participants' knowledge and opinions about TVM and knowledge about recent FDA safety communications. All statistical tests were two-sided, and P values <0.05 were considered statistically significant. RESULTS: Analyses were restricted to the 77 women who had either heard of TVM or were unsure if they had heard of TVM. A minority (32.5 %) of these women correctly defined TVM, and 33.8 % had a negative impression of TVM. Respondents obtained their information on TVM from the media (48.1 %), the Internet (24.7 %), family or friends (22.1 %), and health care providers (18.2 %). The majority (71.4 %) agreed that they needed more information about TVM before making any decisions about using it to treat their condition. Nearly one quarter of respondents (23.4 %) agreed that they would not want their doctor to use TVM on them for any reason. When asked about recent FDA communications, 27.3 % of patients correctly responded that the FDA had released a safety communication regarding TVM. CONCLUSIONS: The majority of participants had limited knowledge of TVM; however, only a minority had negative opinions. Given our findings, it is important that providers spend more time during the consent process explaining TVM and its risks and benefits as a treatment option.

The role of preoperative urodynamics in urogynecologic procedures.

Urodynamic studies refer to any tests that provide objective information about lower urinary tract function with the goal of evaluating bladder and urethral function. Pre-operative urodynamic testing is commonly performed prior to urogynecologic procedures for urinary incontinence and pelvic organ prolapse. Although the utility of preoperative urodynamics testing before urogynecologic procedures have been challenged in the literature, the preoperative utilization of urodynamic testing in women with complex voiding dysfunction or associated conditions such as prolapse or urethral diverticulum is still considered important for surgical planning and pre-operative counseling.

Ergonomics in the operating room: protecting the surgeon.

STUDY OBJECTIVE: To review elements of an ergonomic operating room environment and describe common ergonomic errors in surgeon posture during laparoscopic and robotic surgery. DESIGN: Descriptive video based on clinical experience and a review of the literature (Canadian Task Force classification III). SETTING: Community teaching hospital affiliated with a major teaching hospital. SUBJECTS/AUDIENCE: Gynecologic surgeons. INTERVENTION: Demonstration of surgical ergonomic principles and common errors in surgical ergonomics by a physical therapist and surgeon. MEASUREMENTS AND MAIN RESULTS: The physical nature of surgery necessitates awareness of ergonomic principles. The literature has identified ergonomic awareness to be grossly lacking among practicing surgeons, and video has not been documented as a teaching tool for this population. Taking this into account, we created a video that demonstrates proper positioning of monitors and equipment, and incorrect and correct ergonomic positions during surgery. Also presented are 3 common ergonomic errors in surgeon posture: forward head position, improper shoulder elevation, and pelvic girdle asymmetry. Postural reset and motion strategies are demonstrated to help the surgeon learn techniques to counterbalance the sustained and awkward positions common during surgery that lead to muscle fatigue, pain, and degenerative changes. CONCLUSION: Correct ergonomics is a learned and practiced behavior. We believe that video is a useful way to facilitate improvement in ergonomic behaviors. We suggest that consideration of operating room setup, proper posture, and practice of postural resets are necessary components for a longer, healthier, and pain-free surgical career.

Microlaparoscopy in urogynecology: LSH and sacrocervicopexy.

STUDY OBJECTIVE: To determine the feasibility of using only microlaparoscopic (3.5 mm) accessory instruments for performing laparoscopic supracervical hysterectomy (LSH) and sacrocervicopexy with the aid of a transcervically placed cannula for introduction of mesh and needles. DESIGN: Retrospective evaluation of the first five cases of microlaparoscopic LSH with sacrocervicopexy (Canadian Task Force classification III). SETTING: Community teaching hospital affiliated with a major teaching hospital. PATIENTS: Five women with symptomatic uterovaginal prolapse of stage II or higher. INTERVENTIONS: LSH with transcervical morcellation followed by sacrocervicopexy with all 3.5 mm instruments using synthetic mesh with anterior and posterior extensions. MEASUREMENTS AND MAIN RESULTS: Four ports were made in all patients: a 5-mm infraumbilical port for the laparoscope and three 3.5-mm ports (right and left paraumbilical and suprapubic). LSH was performed using a 3-mm bipolar grasping device and reusable monopolar scissors. Resection of the uterus was also performed using monopolar scissors. Transcervical coring through the vagina was performed using a 15-mm serrated cylindrical blade with a central rod placed upward through the cervix, and transcervical morcellation was performed using an electromechanical morcellator. In all patients, sacrocervicopexy was performed successfully using Y-shaped polypropylene mesh, with PTFE sutures on the vagina and the sacral promontory. Reperitonealization over the mesh was performed using a running barbed absorbable suture. There were no intraoperative or postoperative complications in this group of patients. CONCLUSION: LSH and sacrocervicopexy using 3.5-mm accessory ports is a feasible procedure with the use of transcervical morcellation and a transcervical access cannula.

Musculoskeletal pain in gynecologic surgeons.

OBJECTIVE: To describe the prevalence of musculoskeletal pain and symptoms in gynecologic surgeons. DESIGN: Prospective cross-sectional survey study (Canadian Task Force classification II-2). SETTING: Virtual. All study participants were contacted and participated via electronic means. PARTICIPANTS: Gynecologic surgeons. INTERVENTIONS: An anonymous, web-based survey was distributed to gynecologic surgeons via electronic newsletters and direct E-mail. MEASUREMENTS AND MAIN RESULTS: There were 495 respondents with complete data. When respondents were queried about their musculoskeletal symptoms in the past 12 months, they reported a high prevalence of lower back (75.6%) and neck (72.9%) pain and a slightly lower prevalence of shoulder (66.6%), upper back (61.6%), and wrist/hand (60.9%) pain. Many respondents believed that performing surgery caused or worsened the pain, ranging from 76.3% to 82.7% in these five anatomic regions. Women are at an approximately twofold risk of pain, with adjusted odds ratios (OR) of 1.88 (95% confidence interval [CI], 1.1-3.2; p = .02) in the lower back region, OR 2.6 (95% CI, 1.4-4.8; p = .002) in the upper back, and OR 2.9 (95% CI, 1.8-4.6; p = .001) in the wrist/hand region. CONCLUSION: Musculoskeletal symptoms are highly prevalent among gynecologic surgeons. Female sex is associated with approximately twofold risk of reported pain in commonly assessed anatomic regions.

Laparoscopic supracervical hysterectomy with transcervical morcellation and sacrocervicopexy: initial experience with a novel surgical approach to uterovaginal prolapse.

The objective of this retrospective study was to evaluate the feasibility, safety, and efficacy of a new laparoscopic technique for the treatment of uterovaginal prolapse using a transcervical access port to minimize the laparoscopic incision. From February 2008 through August 2010, symptomatic pelvic organ prolapse in 43 patients was evaluated and surgically treated using this novel procedure. Preoperative assessment included pelvic examination, the pelvic organ prolapse quantification scoring system (POP-Q), and complex urodynamic testing with prolapse reduction to evaluate for symptomatic or occult stress urinary incontinence. The surgical procedure consisted of laparoscopic supracervical hysterectomy with transcervical morcellation and laparoscopic sacrocervicopexy with anterior and posterior mesh extension. Concomitant procedures were performed as indicated. All procedures were completed laparoscopically using only 5-mm abdominal port sites, with no intraoperative complications. Patients were followed up postoperatively for pelvic examination and POP-Q at 6 weeks, 6 months, and 12 months. The median (interquartile range) preoperative POP-Q values for point Aa was 0 (-1.0 to 1.0), and for point C was -1.0 (-3.0 to 2.0). Postoperatively, median points Aa and C were significantly improved at 6 weeks, 6 months, and 12 months (all p < .001). One patient was found to have a mesh/suture exposure from the sacrocervicopexy, which was managed conservatively without surgery. We conclude that laparoscopic supracervical hysterectomy with transcervical morcellation and laparoscopic sacrocervicopexy is a safe and feasible surgical approach to treatment of uterovaginal prolapse, with excellent anatomic results at 6 weeks, 6 months, and 12 months. Potential advantages of the procedure include minimizing laparoscopic port site size, decreasing the rate of mesh exposure compared with other published data, and reducing the rate of postoperative cyclic bleeding in premenopausal women by removing the cervical core. Longer follow-up is needed to determine the durability and potential long-term sequelae of the procedure.

Contemporary Use and Techniques of Laparoscopic Sacrocolpopexy With or Without Robotic Assistance for Pelvic Organ Prolapse.

The past 4 years have been consequential in the world of surgery to correct pelvic organ prolapse. In 2018, results of a large, multicenter randomized trial demonstrated very disappointing cure rates of traditional native tissue repairs at 5 years or more. In 2019, a vaginal mesh hysteropexy kit was removed from the market by the U.S. Food and Drug Administration only to subsequently demonstrate it provided better cure rates and similar risk profile to vaginal hysterectomy plus native tissue repair in its own 5-year study published in 2021. Meanwhile, the use and techniques of laparoscopic sacrocolpopexy with or without robotic assistance have evolved such that it is commonly adapted to treat all support defects for patients with uterovaginal or posthysterectomy prolapse. This article is intended to provide an overview of the contemporary use and techniques of laparoscopic sacrocolpopexy based on the evidence and our clinical experience.

Thirty-six-month Prospective Study of Transvaginal Bovine Graft vs Native Tissue Repair for the Treatment of Pelvic Organ Prolapse.

OBJECTIVE(S): To compare the safety and effectiveness of dermal bovine transvaginal graft, Xenform, to native tissue in the surgical treatment of anterior and/or apical pelvic organ prolapse. This study was designed in conjunction with Food and Drug Administration requirements. METHODS: This was a prospective, non-randomized, parallel cohort, multi-center trial. The primary objective was to demonstrate noninferiority between transvaginal graft and native tissue repair at 36 months compared to baseline. Treatment success was based on a composite of objective and subjective measures. The co-primary outcome was the rate of serious device- or procedure-related adverse events. A total of 228 patients at 25 sites were included in the study arm and 485 patients underwent native tissue repair. Propensity score stratification was applied to achieve balance between treatment groups. Study outcomes were compared in per protocol and intent-to-treat analysis. RESULTS: The primary outcome, treatment success at 36 months, was 83.6% (191/228) for transvaginal graft and 80.5% (390/485) native tissue repair (0.2%, 90% confidence interval [-5.6% to 5.9%]), demonstrating noninferiority at a preset margin of -12%. The overall rate of severe adverse events was 5.3% (12/228) in transvaginal graft vs 2.7% (13/485) in native tissue repair groups. The study group demonstrated noninferiority in serious adverse events at the preset margin of 11.6% (2.0%, 90% confidence interval [-0.8% to 4.7%]). There were no reports of graft erosion, and graft exposure rates were low (0.9% [2/228]). CONCLUSIONS: Transvaginal repair of anterior and/or apical prolapse with a biological graft is noninferior to traditional native tissue repair in effectiveness and safety at 36 months.

Laparoscopic Cerclage Sacrohysteropexy: Comparing a Novel Technique for Sacrohysteropexy to Traditional Supracervical Hysterectomy and Sacrocervicopexy.

OBJECTIVE: The objective of this study was to compare outcomes of laparoscopic cerclage sacrohysteropexy (LCSH), a novel technique used to perform sacrohysteropexy, which requires significantly less suturing and knot tying, to traditional laparoscopic supracervical hysterectomy (LSH) with sacrocervicopexy for the treatment of uterine prolapse. METHODS: This is a retrospective cohort study of all patients who underwent LCSH between March 3, 2016, and October 30, 2018, and patients who underwent LSH with sacrocervicopexy between September 1, 2013, and October 30, 2018. Medical records were reviewed to obtain information on baseline demographics, preoperative pelvic organ prolapse quantification (POP-Q), baseline Pelvic Floor Distress Inventory score, and intraoperative and postoperative outcomes. Apical failure was defined as descent of the cervix beyond the midvagina (C > -TVL/2). Subjective failure was defined as reporting of bulge symptoms, reoperation, or use of a vaginal pessary. RESULTS: Seventy-seven patients who underwent the LCSH procedure and 88 who underwent LSH with sacrocervicopexy were identified. Baseline demographic data were similar between the 2 groups. Operating time was significantly decreased in the LCSH group with median time of 129 minutes (interquartile range, 121-153) versus 199 minutes (interquartile range, 178.5-222.5; P < 0.001) in the traditional cohort. Six weeks after surgery, patients had equivalent POP-Q examinations and Pelvic Floor Distress Inventory scores. At 6 months after surgery, patients similarly had no significant difference in POP-Q examination or scores on standardized questionnaires between the 2 groups. There were no mesh or suture erosions noted in either cohort at any time point. CONCLUSIONS: Laparoscopic cerclage sacrohysteropexy is a novel variation of traditional sacrohysteropexy and an alternative to LSH with sacrocervicopexy that minimizes the dissection and suturing required. This procedure appears to offer equivalent anatomic and subjective outcomes to traditional LSH with sacrocervicopexy with significantly decreased intraoperative time.

Composite Outcomes After Posterior Colporrhaphy With and Without Biologic Graft Augmentation.

OBJECTIVES: To compare subjective and objective failure after posterior colporrhaphy with and without biologic graft augmentation. METHODS: We conducted a retrospective chart review and telephone survey of patients who underwent a posterior colporrhaphy with and without biologic graft augmentation from 2005 to 2019. Patients who underwent a sacrocolpopexy, uterosacral ligament suspensions, or anterior sacrospinous ligament fixation were excluded. We determined objective, subjective, and composite failure rates. RESULTS: Although 137 patients met eligibility criteria, 56 did not have valid contact information and, therefore, were excluded from the study. Of the 81 with valid contact information, 67 (83%) agreed to participate. There were 24 (36%) who had a native tissue repair and 43 (64%) who had biologic graft augmentation. Median telephone follow-up was 73 months (interquartile range [IQR], 36-117). Objective failure was similar for the biologic graft (37%) and the native tissue (42%) groups (P = 0.72). Subjective failure was twice as likely among the biologic graft group (60%) compared with the native tissue group (33%, P = 0.03). Patients with a biologic graft reported a median Pelvic Floor Distress Inventory-Short Form 20 improvement of 31 (IQR, 8-33), while those with a native tissue repair reported a median improvement of 45 (IQR, 4-46). Overall, 78% were satisfied, 85% would recommend the procedure, and 84% reported symptomatic improvement. Reoperation occurred for 15% of patients. CONCLUSIONS: Although biologic graft-augmented posterior colporrhaphy may be a safe and effective treatment option, the use of biologic grafts in the posterior compartment does not appear to confer a significant long-term benefit to traditional posterior colporrhaphy.

Long-term Fecal Incontinence, Recurrence, Satisfaction, and Regret After the Transobturator Postanal Sling Procedure.

OBJECTIVES: The objective of this study was to assess long-term outcomes after the transobturator postanal sling (TOPAS) procedure for the treatment of fecal incontinence. Long-term recurrence, satisfaction and regret after transobturator postanal sling procedure support the ongoing use of this procedure for patients with fecal incontinence. METHODS: Both a retrospective review of medical records and a prospective telephone survey were conducted. For the retrospective review of medical records, all patients who underwent the TOPAS procedure at our institution were eligible. Medical records were reviewed to assess for symptom resolution, retreatment, and complications. For the prospective telephone survey, patients who were conversant in English and had a valid contact information were eligible and were asked to complete questions on satisfaction, the Patient Global Impression of Improvement, the Wexner Symptom Severity Score, the Fecal Incontinence Qualify of Life Scale, and the modified Decision Regret Scale. RESULTS: A total of 134 patients met the inclusion criteria for the retrospective medical record review. Patients were followed in clinic for a median of 24.0 months (interquartile range, 6.0-53.0). Overall, 75.4% reported improvement in fecal incontinence. There were 37 (27.6%) who required subsequent treatment for fecal incontinence. There were 67 patients eligible for the prospective telephone survey, of whom 46 (68.7%) agreed to participate. Median time between surgery and the telephone survey was 63.5 months (interquartile range, 36.0-98.0). Among these participants, 54.3% were satisfied and 60.9% would recommend the procedure to someone else. No adverse events were identified with long-term follow-up. CONCLUSIONS: Our findings suggest that the TOPAS procedure remains a safe and effective therapy for the treatment of fecal incontinence with favorable long-term outcomes.

Survey of Postoperative Activity Guidelines After Minimally Invasive Gynecologic and Pelvic Reconstructive Surgery.

OBJECTIVES: Most surgeons recommend restriction of activities after minimally invasive gynecologic and pelvic reconstructive surgery. The goal of this study was to identify and assess the postoperative guidelines gynecologists and urogynecologists provide their patients. METHODS: This was a cross-sectional study of physicians at a national gynecology conference in March 2018. Respondents were asked to answer questions about the typical postoperative recommendations they provide patients after gynecologic surgery as well as their postoperative prescribing habits. RESULTS: There were 418 attendees, and 135 (32%) eligible physicians completed the survey. Of respondents, 87% were specialists in female pelvic medicine and reconstructive surgery. Most respondents (61%) were in academic practice. Most respondents (82%-86%) recommended specific postoperative lifting restrictions, and 49% to 52% recommended limiting lifting to a maximum of 10 lb after surgery with some variation depending on the surgical procedure performed. Many respondents (42%-56% depending on the surgical procedure) recommended that patients wait at least 2 weeks before returning to sedentary work. Male respondents and those who were in practice for more than 10 years recommended that patients return to work sooner compared with those who were in practice less than 10 years. Male respondents prescribed fewer opioids to patients after vaginal hysterectomy (P = 0.04) and vaginal prolapse repair (P = 0.03) compared with female respondents. CONCLUSIONS: After minimally invasive gynecologic or pelvic reconstructive surgery, providers recommend a wide range of postoperative restrictions and prescribe significantly different quantities of opioids during the postoperative period. This study highlights some of the recommendations with the greatest variability.

Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial.

PURPOSE: The Overactive Bladder Innovative Therapy trial was a randomized, multicenter, controlled study that compared the effectiveness of percutaneous tibial nerve stimulation to extended-release tolterodine. The reduction in overactive bladder symptoms along with global response assessments was evaluated. MATERIALS AND METHODS: A total of 100 adults with urinary frequency were randomized 1:1 to 12 weeks of treatment with weekly percutaneous tibial nerve stimulation or to 4 mg daily extended-release tolterodine. Voiding diaries and an overactive bladder questionnaire were completed at baseline and at the end of therapy to compare 24-hour voiding frequency, urinary urge incontinence episodes, voids causing waking, volume voided, urgency episodes and quality of life indices. Global response assessments were completed by subjects and investigators after 12 weeks of therapy. RESULTS: The global response assessment demonstrated that subject assessment of overactive bladder symptoms compared to baseline was statistically significant in the percutaneous tibial nerve stimulation arm with 79.5% reporting cure or improvement compared to 54.8% of subjects on tolterodine (p = 0.01). Assessments by investigators were similar but did not reach statistical significance (p = 0.05). After 12 weeks of therapy objective measures improved similarly in both groups for reductions in urinary frequency, urge urinary incontinence episodes, urge severity and nighttime voids, as well as for improvement in voided volume. There were no serious adverse events or device malfunctions. CONCLUSIONS: This multicenter, randomized trial demonstrates that percutaneous tibial nerve stimulation is safe with statistically significant improvements in patient assessment of overactive bladder symptoms, and with objective effectiveness comparable to that of pharmacotherapy. Percutaneous tibial nerve stimulation may be considered a clinically significant alternative therapy for overactive bladder.

The Use of Mechanical Bowel Preparation in Pelvic Reconstructive Surgery: A Randomized Controlled Trial.

OBJECTIVE: To compare mechanical bowel preparation (MBP) using oral magnesium citrate with sodium phosphate enema to sodium phosphate (NaP) enema alone during minimally invasive pelvic reconstructive surgery. METHODS: We conducted a single-blind, randomized controlled trial of MBP versus NaP in women undergoing minimally invasive pelvic reconstructive surgery. The primary outcome was intraoperative quality of the surgical field. Secondary outcomes included surgeon assessment of bowel handling and patient-reported tolerability symptoms. RESULTS: One hundred fifty-three participants were enrolled; 148 completed the study (71 MBP and 77 NaP). Patient demographics, clinical and intraoperative characteristics were similar. Completion of assigned bowel preparation was similar between MBP (97.2%) and NaP (97.4%). The MBP group found the preparation more difficult (P<0.01) and reported more overall discomfort and negative preoperative side effects (all P≤0.01). Quality of surgical field at initial port placement was excellent/good in 80.0% of the MBP group compared with 62.3% in the NaP group (P=0.02). This difference was not maintained by the conclusion of surgery (P=0.18). Similar results were seen in the intent-to-treat population. Surgeons accurately guessed preparation 65.7% of the time for MBP versus 41.6% for NaP (P=0.36). At 2 weeks postoperatively, both reported a median time for return of bowel function of 3.0 (2.0-4.0) days. CONCLUSIONS: Mechanical bowel preparation with oral magnesium citrate before minimally invasive pelvic reconstructive surgery offered initial improvement in the quality of surgical field, but this benefit was not sustained. It was associated with an increase in patient discomfort preoperatively, but did not seem to impact postoperative return of bowel function. LEVEL OF EVIDENCE: I.

Effect of Scopolamine Patch Use on Postoperative Voiding Function After Transobturator Slings.

OBJECTIVES: The aim of this study was to determine whether the use of a preoperative transdermal scopolamine (TDS) patch for postoperative nausea and vomiting prophylaxis affects the success of a voiding trial after a transobturator tape sling procedure. METHODS: This study is a retrospective cohort study of adult women who underwent a transobturator tape sling procedure without concomitant procedures from February 1, 2009 through August 1, 2010. The exposed group included all eligible women who received a preoperative TDS patch. For each exposed woman, we selected the next 2 consecutive eligible women who did not receive a TDS patch to be included in the unexposed group. The primary outcome was postoperative voiding trial failure. RESULTS: We identified 35 women who met eligibility criteria and used a preoperative TDS patch, and included 70 women who did not use a preoperative TDS. A significantly higher proportion of women in the TDS patch group (54.3%) failed their voiding trial than in the group that did not receive TDS (7.1%, P ≤ 0.001). A history of an incontinence procedure, older age, and higher body mass index strengthened the association between TDS patch and voiding trial failure. The adjusted model yielded a risk ratio for voiding trial failure of 13.8 (95% confidence interval, 5.2-36.5) for women who received TDS patch compared with those who did not. CONCLUSIONS: The results of this study demonstrate that use of TDS patches for postoperative nausea and vomiting prophylaxis may negatively affect the success of voiding trials after transobturator tape sling procedures.