Permanent Compared With Absorbable Suture for Vaginal Mesh Fixation During Total Hysterectomy and Sacrocolpopexy: A Randomized Controlled Trial.

OBJECTIVE: To compare mesh and permanent suture exposure rates in the first year after minimally invasive total hysterectomy and sacrocolpopexy with a light-weight polypropylene mesh using permanent or delayed absorbable sutures. METHODS: Across five centers in the United States, women were randomized to permanent or delayed absorbable suture for vaginal attachment of a Y-mesh during hysterectomy and sacrocolpopexy for stage II prolapse and worse. The primary outcome was mesh or permanent suture exposure in the first year after surgery. The secondary outcome was to compare a composite measure for success defined as leading edge of prolapse not beyond the hymen and apex not descended more than one third vaginal length, and no subjective bulge and no prolapse retreatment. Patients completed a pelvic examination including the pelvic organ prolapse quantification system and questionnaires at baseline, 6 weeks and 1 year postsurgery. A sample size of 80 per group was planned to compare the rate of mesh or permanent suture exposure in the permanent compared with delayed absorbable groups. RESULTS: From April 2015 to May 2019, 204 patients (n=102 permanent; n=102 delayed absorbable) were randomized. One hundred ninety-eight women had follow-up data, with 182 (93%) completing 1-year follow-up: 95 of 99 (96%) permanent, 87 of 101 (86%) delayed absorbable. The total rate of mesh or permanent suture exposure was 12 of 198 (6.1%): 5.1% for permanent compared with 7.0% for delayed absorbable (risk ratio 0.73, 95% CI 0.24-2.22). The majority (9/12) were asymptomatic. Composite success was 93% for permanent compared with 95% for delayed absorbable suture, P=.43). Six (3.0%) women had a serious adverse event. CONCLUSION: Suture type used for vaginal graft attachment did not influence mesh or permanent suture exposure rates. FUNDING SOURCE: Boston Scientific Corporation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02277925.

The effect of sacral neuromodulation on pudendal nerve function and female sexual function.

AIMS: To quantify changes in pudendal nerve function with sacral neuromodulation (SNM). To understand the relationship of pudendal nerve function to SNM treatment response for overactive bladder. To assess the relationship between female sexual function and pudendal nerve function after SNM. METHODS: Women undergoing SNM between January 2010 and May 2011 were enrolled. Baseline pudendal nerve terminal motor latencies (PNTML) were measured bilaterally. Subjects underwent peripheral nerve evaluation (PNE) prior to SNM therapy. PNTML was measured at 1 and 6 weeks after sacral neuromodulator implant. Women who did not undergo permanent implantation were reassessed at the end of the 1-week PNE testing phase. Pelvic floor and sexual function questionnaires were administered at baseline and follow-up to assess pelvic floor and sexual function. RESULTS: Of 34 women enrolled, 31 were evaluated. Mean age was 67.4 ± 14.2 years with 29/34 (85.3%) treated for refractory overactive bladder. Thirty of 31 (96.7%) went on to a permanent implant. PNE success rate was 73.5% (25/33). Mean PNTML changed from 2.74 ± 0.52 msec at baseline to 2.57 ± 0.50 msec at 6 weeks postop (P = 0.198). Baseline amplitude remained stable at 1 and 6 weeks. At 6 weeks PISQ-12 scores showed improved sexual function (P = 0.034) and PFDI-20 and PFIQ-7 scores showed improved pelvic floor, colorectal and urinary symptoms (P < 0.05). CONCLUSIONS: Women with refractory overactive bladder and non-obstructive urinary retention have abnormal pudendal nerve function, which showed a non-significant trend toward improvement after SNM. Sexually active women undergoing sacral neuromodulation experienced improvement in sexual function. Quality of life improved due to improvement in urinary and colorectal function.

Robotic versus vaginal urogynecologic surgery: a retrospective cohort study of perioperative complications in elderly women.

OBJECTIVES: The primary objective was to compare perioperative complications after robotic surgery (RS) versus vaginal surgery (VS) for apical prolapse repair in elderly women. The secondary objectives were to (1) assess whether tools designed to predict surgical morbidity, the American Society of Anesthesiologists (ASA) class and the Charlson Comorbidity Index (CCI), are useful in the elderly urogynecologic population and (2) to classify complications during urogynecologic apical procedures using the Dindo classification system. METHODS: We reviewed medical records of women 65 years or older who underwent RS or VS between March 2006 and April 2011. Procedures included robotic sacrocolpopexy and sacrocervicopexy, vaginal uterosacral ligament suspension, sacrospinous ligament suspension, colpocleisis, and Uphold vaginal mesh placement. We assessed preoperative risks using ASA and CCI classification and complications using Dindo grade. RESULTS: There were 136 eligible cases (RS, 70; and VS, 66) during the 5-year study period. Women who underwent RS were younger (70 vs 74 years; P < 0.001). Vaginal surgery had more severe comorbidities as measured by the CCI (P = 0.012) but similar ASA profiles (P = 0.10). Robotic surgery had longer operative times (P < 0.001) but a lower estimated blood loss (P < 0.001). There were fewer postoperative complications in RS (P = 0.005). However, complication severity based on Dindo grade was similar between RS and VS, with most surgeries having no complications. CONCLUSIONS: In the elderly women, RS was associated with fewer postoperative complications than VS. Overall, all procedures were associated with few complications, and either route may be reasonable in the elderly population.

Relationship between race and abdominal anatomy: effect on robotic port placement.

OBJECTIVES: We sought to characterize differences between African American women and white women in abdominal wall dimensions that could affect robotic port placement. By better understanding these differences, surgeons could assess and adjust port placement to accommodate varying abdominal wall anatomy. METHODS: A radiologist blinded to race-reviewed abdominal/pelvic computed tomographic scans of women aged 30 to 70 prescreened for demographic inclusion criteria. These consecutive scans were screened for radiologic exclusion criteria until 40 consecutive scans from each race were identified and included. RESULTS: Eighty of 663 patients, 40 of each race, met demographic inclusion criteria. The most common radiologic feature disqualifying the scans included absence of the xiphoid process on the scan and anterior abdominal wall deformity. Demographic variables including age, weight, height, and body mass index were similar between groups. Symphysis pubis to umbilicus measurement was shorter in the African American group (15.7 [2.1] vs 17.1 [2.0]; P < 0.001) and intra-anterior superior iliac spine distance was narrower (21.4 [1.2] vs 23.8 [2.0]; P = 0.003), creating an overall smaller lower abdomen in African American women. Total abdominal length was the same between groups (36.6 [2.6] vs 36.7 [2.8]; P = 0.851). Using linear regression, height, weight, and body mass index did not affect lower abdominal dimensions, whereas age (P < 0.001) had a significant inverse relationship with the symphysis pubis to umbilicus measurement. CONCLUSIONS: Lower abdominal dimensions between races vary, with the umbilicus serving as an inconsistent landmark. Variance exists that can be attributed to racial differences. Assessment of these dimensions at the time of robotic surgery could lead to improved port spacing and therefore fewer arm collisions, improving robotic efficiency.

Obstetric sphincter injury interacts with diarrhea and urgency to increase the risk of fecal incontinence in women with irritable bowel syndrome.

OBJECTIVES: This study aimed to confirm that fecal urgency and diarrhea are independent risk factors for fecal incontinence (FI), to identify obstetrical risk factors associated with FI in women with irritable bowel syndrome, and to determine whether obstetric anal sphincter injuries interact with diarrhea or urgency to explain the occurrence of FI. METHODS: The study is a supplement to a diary study of bowel symptoms in 164 female patients with irritable bowel syndrome. Subjects completed daily bowel symptom diaries for 90 consecutive days and rated each bowel movement for stool consistency and presence of urgency, pain, and FI. All female participants from the parent study were invited to complete a telephone-administered 33-item bowel symptom and obstetric history questionnaire, which included the fecal incontinence severity index. RESULTS: Of the 164 women in the parent study, 115 (70.1%) completed the interview. Seventy-four (45.1%) reported FI on their diary including 34 (29.6%) who reported at least 1 episode per month, 112 (97.4%) reported episodes of urgency, and 106 (92.2%) reported episodes of diarrhea. The mean fecal incontinence severity index score was 13.9 (9.7). On multivariable analysis, FI was significantly associated with parity (P = 0.007), operative abdominal delivery (P = 0.049), obstetrical sphincter lacerations (P = 0.007), fecal urgency (P = 0.005), diarrhea (P = 0.008), and hysterectomy (P = 0.004), but was not associated with episiotomy, pelvic organ prolapse, or urinary incontinence. The synergistic interactions of obstetric anal sphincter laceration with urgency (P = 0.002) and diarrhea (P = 0.004) were significant risk factors for FI. CONCLUSIONS: Fecal urgency and diarrhea are independent risk factors for FI, and they interact with obstetric anal sphincter laceration to amplify the risk of FI.

Effect of anticholinergic use for the treatment of overactive bladder on cognitive function in postmenopausal women.

BACKGROUND: Overactive bladder (OAB) is a common condition affecting the elderly. The mainstay of treatment for OAB is medical therapy with anticholinergics. However, adverse events have been reported with this class of drugs, including cognitive changes. OBJECTIVE: The objective of this study was to investigate the effect of an anticholinergic medication, trospium chloride, on cognitive function in postmenopausal women being treated for OAB. METHODS: This was a prospective cohort study conducted at a urogynaecology clinic at one academic medical centre from January to December 2010, with 12-week follow-up after medication initiation. Women aged 55 years or older seeking treatment for OAB and opting for anticholinergic therapy were recruited. Baseline cognitive function was assessed via the Hopkins Verbal Learning Test-Revised Form (HVLT-R) [and its five subscales], the Orientation, Memory & Concentration (OMC) short form, and the Mini-Cog evaluation. After initiation of trospium chloride extended release, cognitive function was reassessed at Day 1, Week 1, Week 4 and Week 12. Bladder function was assessed via three condition-specific quality-of-life questionnaires. Secondary outcomes included change in bladder symptoms, correlation between cognitive and bladder symptoms, and overall medication compliance. The main outcome measure was change in HVLT-R score at Week 4 after medication initiation, compared with baseline (pre-medication) score. RESULTS: Of 50 women enrolled, 35 completed the assessment. The average age was 70.4 years and 77.1% had previously taken anticholinergic medication for OAB. At enrollment 65.7% had severe overactive bladder and 71.4% had severe urge incontinence. Cognitive function showed an initial decline on Day 1 in HVLT-R total score (p = 0.037), HVLT-R Delayed Recognition subscale (p = 0.011) and HVLT-R Recognition Bias subscale (p = 0.01). At Week 1 the HVLT-R Learning subscale declined from baseline (p = 0.029). All HVLT-R scores normalized by Week 4. OMC remained stable throughout. The Mini-Cog nadired at a 90.9% pass rate at Week 4. OAB symptoms did not improve until Week 4, based on questionnaire scores (p < 0.05). CONCLUSION: Cognitive function exhibited early changes after initiation of trospium chloride but normalized within 4 weeks. Cognitive changes occurred weeks prior to OAB symptom improvement. Surveillance for cognitive changes with anticholinergic use should be part of OAB management.

Robotic vs abdominal sacrocolpopexy: 44-month pelvic floor outcomes.

OBJECTIVE: To evaluate longer-term clinical outcomes after robotic vs abdominal sacrocolpopexy for the treatment of advanced pelvic organ prolapse (POP). MATERIAL AND METHODS: This was a retrospective cohort assessment of women undergoing either robotic or abdominal sacrocolpopexy between March 2006 and October 2007. Pelvic floor support was measured using Pelvic Organ Prolapse Quantification (POP-Q) examination, and pelvic floor function was assessed via validated questionnaires, including the Pelvic Floor Distress Inventory (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7), and Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12). RESULTS: The analysis included 51 subjects: 23 robotic and 28 abdominal. Mean time since surgery was 44.2 ± 6.4 months. Postoperative POP-Q improved similarly from baseline in both the robotic and abdominal groups: C (-8 vs -7), Aa (-2.5 vs -2.25), Ap (-2 vs -2) (all P >.05 based on route of surgery). Pelvic floor function also improved similarly in both groups: PFDI-20 (61.0 vs 54.7), PFIQ-7 (19.1 vs 15.7), with high sexual function PISQ-12 (35.1 vs 33.1) (all P >.05 based on route of surgery). Two mesh exposures occurred in each group for a rate of 8% and 7%, respectively. CONCLUSION: Robotic sacrocolpopexy demonstrates similar long-term outcomes compared with abdominal sacrocolpopexy. The robotic approach offers an effective treatment alternative to abdominal sacrocolpopexy for the lasting treatment of advanced POP.

Diagnostic accuracy of visual urethral mobility exam versus Q-Tip test: a randomized crossover trial.

OBJECTIVE: The objective of the study was to compare the diagnostic accuracy of a visual urethral mobility examination (VUME) with a Q-Tip test in the assessment of urethral hypermobility. STUDY DESIGN: Subjects were randomized to a VUME or Q-Tip test first, followed by the alternate assessment. Outcomes included hypermobile, not hypermobile, or indeterminate. Hypermobility was defined as 30° or greater from the horizontal. Pain perception and test preference were assessed. RESULTS: For the 54 subjects, 61.1% demonstrated hypermobility on VUME vs 72.2% on the Q-Tip test (P = .39). Assessment of hypermobility was correlated between the 2 tools (ρ = 0.47, P = .001). Positive and negative predictive value, sensitivity, and specificity for VUME were 88%, 56%, 78%, and 71%, respectively, with a Q-Tip test as the reference standard. Mean pain score on visual analog scale was 0.72 for VUME and 3.15 for Q-tip test (P < .001). VUME was preferred by 83% of subjects. CONCLUSION: VUME is a diagnostic alternative to the Q-Tip test for the assessment of urethral hypermobility and is preferred by subjects.

Genitofemoral and perineal neuralgia after transobturator midurethral sling.

BACKGROUND: Midurethral slings successfully treat stress urinary incontinence through a minimally invasive vaginal approach. Postoperative pain related to sling placement can occur and poses both diagnostic and treatment dilemmas. CASE: Four years after transobturator midurethral sling placement, the patient presented with complaints of left labial pain and dyspareunia since surgery. Using sensory mapping and a nerve stimulator, the problem was identified in the distribution of the genitofemoral nerve. Conservative therapy with a centrally acting neuromodulatory drug and nerve block relieved the pain. CONCLUSION: Postsling neuralgia diagnosis using sensory mapping and a nerve stimulator aids in indentifying the nerve involved and in successful conservative treatment with a nerve block.

Endometrial receptivity defects during IVF cycles with and without letrozole.

BACKGROUND: Our aim was to study ways to improve IVF success rates in women with suspected endometrial receptivity defects. METHODS: We conducted a retrospective cohort study examining the effect of letrozole (aromatase inhibitor) on integrin expression as a marker of endometrial receptivity. We compared IVF outcomes in 97 infertile women who had undergone ανß3 integrin assessment by immunohistochemistry in mid-luteal endometrial biopsies. Of 79 women undergoing standard IVF, 29 (36.7%) lacked normal integrin expression. Eighteen other women with low integrin were studied after receiving letrozole during early IVF stimulation. An independent set of ανß3 integrin-negative patients (n = 15) who had undergone repeat endometrial biopsy for integrin testing while taking letrozole were re-evaluated. RESULTS: Clinical pregnancy and delivery rates were higher in women with normal ανß3 integrin expression compared with those who were integrin negative [20/50 (40%) versus 4/29 (13.8%); P = 0.02 and 19/50 (38%) versus 2/29 (7%); P < 0.01, respectively]. In 18 women who received letrozole early in IVF, 11 conceived (61.1%; P < 0.001) compared with integrin-negative patients who did not receive letrozole. In integrin-negative women who were rebiopsied on letrozole, 66.7% reverted to normal integrin expression. Positive endometrial aromatase immunostaining using a polyclonal antibody was a common finding in infertile patients compared with controls. CONCLUSIONS: Lack of endometrial ανß3 integrin expression is associated with a poor prognosis for IVF that might be improved with letrozole co-treatment. Prospective studies are needed to confirm and extend these findings but the data suggest that aromatase expression may contribute to implantation failure in some women.

Diagnostic accuracy of retrograde and spontaneous voiding trials for postoperative voiding dysfunction: a randomized controlled trial.

OBJECTIVE: To compare the diagnostic accuracy of two voiding trial methods to predict postoperative voiding dysfunction. METHODS: Women undergoing operations for urinary incontinence, prolapse, or both urinary incontinence and prolapse from November 2009 and March 2010 were randomized into one of two groups: retrograde or spontaneous. All patients underwent both techniques of voiding trials with randomization determining order. RESULTS: Fifty women were randomized to 25 per group. Failure rates were 62% for retrograde and 84% for spontaneous. Women who failed both had 12.6±14.4 days of retention compared with 2.5±2.1 days for those who failed only one method (P=.004). The retrograde method had 94.4% sensitivity and 58.1% specificity to detect postoperative voiding dysfunction lasting at least 7 days compared with the spontaneous method with 100% sensitivity and 25.8% specificity. Positive and negative predictive values for the retrograde method were 56.7% and 94.7%, respectively, compared with the spontaneous method with 43.9% and 100%. Retrograde was preferred by patients (51.1% compared with 44.4%) regardless of randomization. CONCLUSION: The retrograde method is more accurate in evaluating postoperative voiding dysfunction, although both tests had a low positive predictive value. A longer period of retention was seen with failure of both methods. Retrograde was preferred by patients and provides an efficient alternative to the spontaneous method of voiding trial. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01091844. LEVEL OF EVIDENCE: I.

Robot-assisted techniques and outcomes in the realm of pelvic reconstructive surgery.

Robotic-assisted surgery for the treatment of pelvic organ prolapse continues to grow in popularity as more surgeons adopt this technology. Encompassing all of the benefits of laparoscopic surgery, robotic-assisted techniques allow more surgeons the ability to perform complex tasks such as meticulous deep pelvic dissection and extensive suturing without having to resort to laparotomy. This chapter reviews the techniques involved in the robotic approach to pelvic reconstructive surgery and discusses the currently available information focusing on the outcomes of this procedure.

Overlapping anal sphincteroplasty: impact of suture selection on bowel symptoms.

OBJECTIVE: To look at women who underwent overlapping anal sphincteroplasty (OAS) with the use of either permanent or absorbable sutures and to describe patient-reported fecal continence and quality of life. STUDY DESIGN: A case series of 40 women who underwent OAS completed the Modified Manchester Health Questionnaire a mean of 50 months after surgery. Descriptive statistics were used to describe those who had permanent sutures and those who had absorbable sutures. RESULTS: The primary outcome, loss of solid stool, was similar at 50% for each group. Severity of incontinence symptoms, as measured by the Fecal Incontinence Severity Index, was lower in the permanent suture group (15.9 vs. 24.0). There was no difference in overall impact on quality of life. CONCLUSION: While overall patient-reported fecal incontinence was similar, permanent suture use at time of OAS was associated with decreased fecal incontinence severity.

Pelvic floor function before and after robotic sacrocolpopexy: one-year outcomes.

STUDY OBJECTIVE: Estimate pelvic floor function and support 1 year after robotic sacrocolpopexy. DESIGN: Prospective cohort analysis of women undergoing robotic sacrocolpopexy for correction of advanced pelvic organ prolapse (Canadian Task Force Classification III). Primary outcome was pelvic floor function. Secondary outcomes included anatomic support and long-term surgical failures and complications. SETTING: One university hospital in the southeastern United States. PATIENTS: Primarily postmenopausal women (mean age 60) with advanced pelvic organ prolapse. INTERVENTIONS: All subjects underwent robotic sacrocolpopexy during the study period. Subjects then underwent 1-year postoperative assessment of pelvic floor function via validated condition-specific quality of life questionnaires and assessment of pelvic floor support, long-term surgical failures, and complications via physical examination. MEASUREMENTS AND MAIN RESULTS: From November 2007 to April 2009, there were 28 subjects, 25 of whom (89.3%) were evaluated. Mean time since surgery was 14.8 months. Pelvic floor function remained significantly improved over preoperative baseline: PFDI-20 (117 vs 38, p <.001), PFIQ-7 (60 vs 10, p = .001), with stable high sexual function: PISQ-12 (34 vs. 36, p = .17), and improved pelvic support on POP-Q: Ba (+3 vs -2, p = .001), Bp (+0.5 vs -1, p = .092), C (+2.25 vs -8, p = .001). Anatomic cure for vault prolapse was 100% at 1 year. There were two mesh exposures and two subsequent prolapse surgeries. CONCLUSION: Robotic sacrocolpopexy demonstrates durable improvement in pelvic floor function and support, with high sexual function and reasonable failure and complication rates 1 year after surgery.

Bupivacaine injection during midurethral sling and postoperative pain: a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to investigate the impact of retropubic injection of 0.125% bupivacaine during midurethral sling placement on postoperative pain. METHODS: A randomized, double-blind trial of 42 women undergoing midurethral sling for stress incontinence was conducted. The intervention group received an injection of 0.125% bupivacaine in the retropubic space prior to midurethral sling placement, while the control group received no injection. Pain scores were recorded via a 10-cm visual analog scale at 2, 6, and 24 h postoperatively. RESULTS: Pain scores were lower in the bupivacaine group compared to the control group at 2 h (1.9 versus 2.6, p = 0.05). Mean pain scores were similar at all other time points (all p > 0.45). Participants in both groups used similar amounts of pain medication in the hospital, except that patients in the bupivacaine group used more PO non-steroidal anti-inflammatory drugs (p = 0.047). CONCLUSIONS: Retropubic injection of 0.125% bupivacaine at the time of midurethral sling placement decreases short-term postoperative pain.

A novel approach to teaching the pelvic organ prolapse quantification (POP-Q) exam.

INTRODUCTION AND HYPOTHESIS: The purpose of this study is to develop an inexpensive, feasible, and useful 3-D model for teaching and performing the pelvic organ prolapse quantification (POP-Q) exam. METHODS: We constructed POP-Q models using socks and cardboard tubing. During lectures at two residency programs, residents completed a self-assessment before and after using the model. We dichotomized learners into "beginner learners" (PGY-1-2s) and "experienced learners" (PGY-3-4s). Change in understanding, comfort performing, and confidence in teaching the POP-Q and perceived usefulness of the model were then assessed based on learner experience. RESULTS: The models took 2 h to build and cost seven dollars. Ninety percent (26/29) of residents completed both questionnaires. Eighty-nine percent "agreed" or "strongly agreed" the model was useful. All self-assessment questions regarding the POP-Q exam improved after training for both groups. CONCLUSIONS: The "sock-and-tube" model is an inexpensive, easily constructed model for teaching the POP-Q exam that residents found useful and with improved understanding of and comfort with the exam.

Validation of web-based administration of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12).

INTRODUCTION AND HYPOTHESIS: We studied a web-based version of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12). METHODS: A randomized crossover study in which subjects completed both a web-based and paper-based version of the PISQ-12, with a 2-week separation between the completion of the two versions. Demographic data and questionnaire preferences were also assessed. Group 1 completed the web version first, and group 2 completed the paper version first. RESULTS: We recruited 52 women and 50 (96.2%) completed the study. Demographic data were similar for the two groups. There was no difference in total PISQ-12 score (P = 0.41) and a high degree of correlation between versions (r = 0.88). Women preferred the web-based PISQ-12 (77.6%) over the paper-based version. CONCLUSION: The web-based version of the PISQ-12 is a reliable alternative to the standard paper-based version and was preferred by women in this study regardless of age, race, and education.

Urethral condyloma accuminata causing bladder outlet obstruction in pregnancy: a case report.

BACKGROUND: Condyloma accuminata represents the most common sexually transmitted disease in the United States. Pregnancy can lead to enlargement of existing lesions or development of new lesions. CASE: A 31-year-old woman presented at 28 weeks' gestation with a complaint of difficulty voiding due to an obstructing urethral mass. In the weeks preceding presentation voiding had become progressively more difficult, leading to Valsalva voiding, the use of the Credé maneuver and the sensation of incomplete emptying. Excision in the office setting resulted in complete resolution of her symptoms with return to normal voiding. CONCLUSION: Resection of obstructive urethral condyloma can be a safe and effective treatment for bladder outlet obstruction during pregnancy with rapid return to normal voiding.