Anatomical Relationships of Burch Colposuspension Sutures Objectives: The prevalent use of minimally invasive midurethral slings for the treatment of stress urinary incontinence in the last several decades has resulted in fewer Burch procedures being performed and diminished surgical experience in performing the Burch colposuspension. However, recent antimesh media has resulted in more patients requesting nonmesh anti-incontinence procedures and a subsequent need for surgeons to refamiliarize themselves with the Burch procedure and its relevant anatomy. The objective of this study was to evaluate the relationships of Burch sutures to surrounding neurovascular anatomic structures in the human cadaver.
Methods: The retropubic space of 11 unembalmed female cadavers was dissected, and a Burch procedure performed. The distance from the Burch sutures’ location through both Cooper’s ligament and the vagina to the obturator neurovascular bundle and external iliac vessels was measured.
Results: The mean distance from the most lateral stitch in Cooper’s ligament to the obturator bundle was 25.9 ± 7.6 mm and to the external iliac vessels was 28.9 ± 9.3 mm, and in some instances, these structures were less than 1.5 cm away.
Conclusions: The obturator bundle and external iliac lie, on average, within 3 cm of sutures placed during a Burch colposuspension. Knowledge of these anatomical relationships is valuable when dissecting the space of Retzius and placing sutures for a Burch to avoid injury.
Characteristics of Providers Performing Urogynecologic Procedures on Medicare Patients 2012–2014 Objective: To analyze the characteristics of providers performing stress urinary incontinence (SUI) and pelvic organ prolapse (POP) procedures in the United States.
Methods: The Centers for Medicare Services public database, released for years 2012 through 2014, was queried for SUI-related and POP-related Healthcare Common Procedure Coding System. Providers were categorized as Female Pelvic Medicine and Reconstructive Surgery (FPMRS) providers and non-FPMRS providers, using a list of FPMRS board-certified providers compiled through the American Board of Medical Subspecialties website. Other physician specialties that submitted SUI and POP procedures claims were tabulated.
Results: Six hundred twenty-nine FPMRS and 833 non-FPMRS providers submitted claims for SUI and POP procedures. The SUI procedures claims had the following provider specialty distribution: obstetrics and gynecology (OB/GYN)—FPMRS, 46.7%; urology, 26.3%; OB/GYN, 12.2%; and urology—FPMRS, 13.9%, with the remaining 0.9% being performed by other specialties. The POP procedures had the following specialty distribution: OB/GYN—FPMRS, 63.4%; OB/GYN, 16.7%; urology, 8.3%; and urology—FPMRS, 7.1%, with the remaining 4.5% being performed by other specialties.
Provider distribution was compared between transvaginal mesh and sling insertion procedures to transvaginal mesh and sling removal procedures. The FPMRS providers claimed 63.6% of sling and transvaginal mesh insertion procedures and performed 84.9% of mesh and sling removal procedures.
Conclusions: Medicare reimbursement data provides a unique insight into the distribution of provider specialties performing SUI-related and POP-related procedures in the Medicare population. The OB/GYN-FPMRS providers submitted the majority of claims for SUI and POP procedures from 2012 to 2014. The FPMRS providers are also performing the majority of mesh removal procedures.
The Effect of Intravenous Acetaminophen on Postoperative Pain and Narcotic Consumption After Vaginal Reconstructive Surgery: A Double-Blind Randomized Placebo-Controlled Trial Objective: This study aimed to determine the effect of intravenous acetaminophen versus placebo on postoperative pain, satisfaction with pain control, and narcotic use after vaginal reconstructive surgery.
Methods: This was an institutional review board-approved, double-blind placebo-controlled randomized trial. Women scheduled for reconstructive surgery including vaginal hysterectomy and vaginal vault suspension were enrolled. Subjects received 1000 mg of intravenous acetaminophen or 100 mL placebo every 6 hours for 24 hours. Pain and satisfaction with pain control were assessed using visual analog scales and a numeric rating scale. Visual analog scales were collected at 18 and 24 hours postoperatively and at discharge. A sample size calculation determined 90 subjects would be required to detect a 30% reduction in postoperative narcotic use with 80% power and significance level of 0.05.
Results: One hundred subjects were enrolled. There were no differences in demographics or surgical data and no difference in narcotic consumption at multiple evaluation points. At 18 hours postoperative, median pain scores at rest were 27.0 (interquartile range, 35.0) for acetaminophen and 35.0 (interquartile range, 44.5) for placebo, finding no difference (P = 0.465). Furthermore, pain with activity and numeric rating scale-assessed pain scales were similar (P = 0.328; P = 0.597). Although satisfaction with pain control was high overall (91.5), no difference was noted.
Conclusions: Patients undergoing vaginal reconstructive surgery receiving perioperative intravenous acetaminophen did not experience a decrease in narcotic requirements or postoperative pain when compared with placebo. Reassuringly, pain scores were low and satisfaction with pain control was high for all subjects. The general use of this medication is not supported in these surgical patients.
Validating the Postdischarge Surgical Recovery Scale 13 as a Measure of Perceived Postoperative Recovery After Laparoscopic Sacrocolpopexy Objectives: No postoperative recovery measurement tools have been validated among women undergoing laparoscopic sacrocolpopexy for pelvic organ prolapse, which impedes development and testing of strategies to improve recovery. The purpose of this study was to evaluate the performance of the Postdischarge Surgical Recovery Scale (PSR) as a measure of perceived recovery in laparoscopic sacrocolpopexy patients.
Methods: Women (N = 120) with stage 2 or higher pelvic organ prolapse undergoing laparoscopic sacrocolpopexy completed a 15-minute postoperative survey (days 7, 14, 42, and 90 [each ± 3 days]) which included the 15-item PSR. A confirmatory factor analysis was conducted using data from 14 days postsurgery, when patients would have begun to recover, but there was likely to be substantial variability in recovery across patients. We also assessed validity and explored sensitivity to change over time and minimally important difference values.
Results: Confirmatory factor analysis indicated a good fitting model for a reduced version of the PSR (ie, PSR13). Regressions showed that the PSR13 prospectively predicted single-item recovery scores. The PSR13 recovery significantly improved from days 7 to 42, suggesting the PSR13 is sensitive to change. Descriptive statistics including minimally important differences are reported. The minimally important difference was estimated to be around 5 points.
Conclusions: The PSR13 is a psychometrically sound tool for measuring recovery over time in this population. Its short length makes it an ideal postoperative recovery measure in clinical practice or research.
Obstetrical Anal Sphincter Injuries: Does Obstetrical Care Provider Matter? A Quality Assurance Study in Ontario Objectives: We sought to determine the rates of obstetrical anal sphincter tears (OASIS) between types of obstetrical care providers at Kingston General Hospital (KGH) and in Ontario via the Better Outcomes Registry Network (BORN).
Methods: This cross-sectional study collected patient, demographic, and delivery data from all vaginal deliveries at KGH from June 2011 to June 2014 and all vaginal deliveries through the BORN database from June 2012 to June 2014.
Results: During this period, 4.6% and 3.5% of all vaginal deliveries at KGH and in Ontario, respectively, were complicated by OASIS. The OASIS' rates were not statistically different between admitting care providers at KGH: 4.9%, 3.8%, and 3.7% of vaginal deliveries by obstetricians, family physicians, and midwives, respectively, in contrast to a higher rate of OASIS in women admitted under midwifery care in the province-wide data: 3.4%, 3.2%, and 4.4% for obstetricians, family physicians, and midwives, respectively. The rate of OASIS in patients who had an intrapartum transfer of care (TOC) from a family physician or midwife to an obstetrician was 13.8% at KGH, and 13.6% as reported by BORN, significantly higher than 3.8% (KGH) or 2.9% (BORN) in those who remained under the family physician, or midwife. The relative risk of OASIS in women transferred to an obstetrician compared to those who were admitted and delivered by an obstetrician was 3.9 (95% confidence interval, 3.6–4.3, P < 0.0001).
Conclusions: Only when an intrapartum TOC is needed does the OASIS rate substantially increase, reflecting the underlying indication for TOC is leading to more intervention associated with risk of OASIS.
Comparative Perioperative Pain and Recovery in Women Undergoing Vaginal Reconstruction Versus Robotic Sacrocolpopexy Background: In this study of patients undergoing vaginal hysterectomy with either robotic or vaginal prolapse repair, there was no difference in quality of life in the weeks following surgery; however, less narcotics were used, less pain was documented by nurses and Surgical Pain Scale (SPS), and better performance on voiding trials was noted in those undergoing robotic sacrocolpopexy.
Objectives: Minimally invasive surgery for pelvic organ prolapse is the preferred surgical route for optimal recovery. However, information regarding patient-centered outcomes among various techniques is lacking. We sought to describe pain and quality of life in patients undergoing vaginal hysterectomy with uterosacral ligament suspension (USLS) compared with robotic-assisted sacrocolpopexy (RSC).
Methods: This institutional review board–approved prospective cohort study enrolled consecutive patients undergoing vaginal hysterectomy with USLS or with RSC. The primary outcome was pain on postoperative day 1 using the SPS. Nursing verbal pain scores, narcotic usage, surgical data, and Short-Form Health Survey 12 at baseline and 2 and 6 weeks after surgery were collected. A sample size calculation revealed 37 subjects per group would be required.
Results: Seventy-eight women were enrolled (USLS, n = 39; RSC, n = 39). There were no significant differences in scores on the SPS between groups. Subjects undergoing RSC had lower nursing verbal pain scores (P = 0.04), less narcotic consumption (P = 0.02), and lower estimated blood loss (P = 0.01) and were less likely to fail voiding trials (P < 0.001); however, surgery duration was longer (P < 0.001). After controlling for age, regression analysis revealed SPS “worst pain” was lower in the robotic arm (P = 0.01), but not in other scales of the SPS. At 2 and 6 weeks postoperatively, Short-Form Health Survey 12 scores were not different between cohorts.
Conclusions: Both USLS and RSC are minimally invasive, with similar quality-of-life scores after surgery. However, the robotic approach may be associated with less pain, less narcotic use, and better performance in voiding trials. Surgeons should consider these findings when counseling patients regarding treatment options.
Neutrophil Gelatinase–Associated Lipocalin Biomarker and Urinary Tract Infections: A Diagnostic Case-Control Study (NUTI Study) Objectives: Acute uncomplicated urinary tract infection (UTI) in women is often treated based on symptoms alone. Urinary tract infection symptoms are highly sensitive but lack specificity and result in overuse of antibiotics. We sought to determine if urine neutrophil gelatinase–associated lipocalin (uNGAL) levels in urine can accurately discriminate between UTI and healthy women.
Methods: We recruited adult women aged 18 to 85 years presenting in the ambulatory setting from November 2014 to January 2016. Cases were defined as women with Centers for Disease Control and Prevention–defined UTI symptoms and a positive urine culture of more than 105 organisms/mL on a midstream clean-catch specimen. Women without UTI symptoms were matched by age and menopausal status as control subjects. Exclusion criteria were no UTIs within 8 weeks, urinary tract anomalies, renal disease, pregnancy, or diabetes. Clean-catch urine samples were obtained for measuring uNGAL, prior to antibiotic treatment of cases. We used Mann-Whitney U test to compare the 2 groups. Receiver operating characteristic curves were plotted to compare the performance of uNGAL to established urinary markers.
Results: We enrolled 50 UTI cases and 50 control subjects. Urine NGAL levels were higher in the UTI group than in the control subjects (P < 0.0001). Using a cutoff of 23.9 ng/mL, NGAL achieved 98% sensitivity and 100% specificity. The receiver operating characteristic curve had an area under the curve of 0.97 (95% confidence interval, 0.93–1.00), which was significantly high and showed that uNGAL can identify UTI.
Conclusions: Urine NGAL has the potential as a biomarker for diagnosing UTIs in adult women.
Prospective Outcomes of a Pelvic Floor Rehabilitation Program Including Vaginal Electrogalvanic Stimulation for Urinary, Defecatory, and Pelvic Pain Symptoms Objectives: This study evaluated our experience after implementing a pelvic floor rehabilitation program including behavioral modification, biofeedback, and vaginal electrogalvanic stimulation (EGS).
Methods: This prospective cohort study evaluated outcomes of patients with pelvic floor dysfunction (urinary or defecatory dysfunction, pelvic pain/dyspareunia) who underwent pelvic floor rehabilitation. Patients received 4 to 7 sessions (1 every 2 weeks) including biofeedback and concluded with 30 minutes of vaginal EGS. Surveys assessed subjective changes in symptoms; success was evaluated using a 10-point visual analog scale (VAS) at the final session (10 = most successful). Paired comparisons of responses at baseline and final treatment were evaluated.
Results: Ninety-four patients were followed up through therapy completion. Treatment indications included urinary (89.4%), defecatory (33.0%), and pelvic pain or dyspareunia (30.9%); 44.7% of patients had a combination of indications. Among women with urinary symptoms, the percentage reporting leakage decreased from 92.9% to 79.3% (P = 0.001), leakage at least daily decreased from 69.0% to 39.5% (P < 0.001), daily urgency with leakage decreased from 42.7% to 19.5% (P = 0.001), daily urgency without leakage decreased from 41.5% to 18.3% (P < 0.001), and median VAS rating (0 = not at all, 10 = a great deal) of daily life interference decreased from 5 to 1.5 (P < 0.001). The median success ratings were 8, 8, and 7 for treatment of urinary symptoms, pelvic pain/dyspareunia, and bowel symptoms, respectively.
Conclusions: An aggressive pelvic rehabilitation program including biofeedback with vaginal EGS had a high rate of self-reported subjective success and satisfaction and should be considered a nonsurgical treatment option in patients with pelvic floor dysfunction.
Levator Ani Muscle Defects in Patients With Surgical Failure Introduction: The objective of the study was to use a well-described system of measuring levator ani (LA) muscle defects from magnetic resonance images to evaluate whether major defects are correlated to an increased risk of surgical failure.
Methods: A retrospective cohort study performed on patients who underwent laparoscopic uterosacral ligament suspension from 2010 to 2012. Surgical failure was defined as a composite score of anatomic bulge beyond the hymen with sensation of bulge or repeat treatment of prolapse via pessary or surgery by 1-year follow-up. Levator ani muscle defects were graded by a score of 0 (no defect), 1 (<50% muscle bulk missing), 2 (>50% muscle bulk missing), or 3 (complete loss of muscle). Total score is the sum from both graded sides, with 0 classified as having no defect, 1 to 3 classified as having minor defects, and 4 to 6 classified as having major defects. Dichotomous values of LA major defects were compared against dichotomous values of surgical outcomes via a contingency table. Fisher exact test was then performed to correlate major defects to surgical success/failure. P value of less than 0.05 was considered statistically significant.
Results: Sixty-six women met the inclusion criteria. Thirteen (19.6%) patients met the criteria for surgical failure at 1 year. Of the 13, 54% (7) had a major defect, and 46% (6) had a minor or no defect (odds ratio, 1.31; 95% confidence interval, 0.39–4.41; P = 0.762).
Conclusions: We did not find a statistical correlation to surgical failure after a laparoscopic uterosacral ligament suspension with LA muscle defects on preoperative magnetic resonance images within this specific patient population.
Effect of Trospium Chloride on Cognitive Function in Women Aged 50 and Older: A Randomized Trial Objectives: This study aimed to investigate the effect of trospium chloride on cognitive function in postmenopausal women treated for overactive bladder (OAB).
Methods: Randomized double-blind placebo-controlled trial conducted from April 2013 to April 2015. Women aged 50 years or older seeking treatment for OAB were randomized to either trospium chloride XR 60 mg daily or placebo. Baseline cognitive function was assessed via Hopkins Verbal Learning Test-Revised (HVLT-R), Mini Mental Status Exam, Mini Mental Status X, Digit Span, Trails A, Trails B, and Epworth Sleepiness Scale. Cognitive function was reassessed at week 1 and week 4. A priori power analysis determined that 21 subjects were needed per group.
Results: Although 59 women were enrolled and randomized (28 trospium and 31 placebo), 45 completed assessment (21 trospium and 24 placebo). Mean age was 68 years, 78% were white, and 44% had previously taken OAB medication. For the primary outcome, there was no difference in HVLT-R total score between trospium and placebo groups at week 4 (P = 0.29). There were also no differences based on the other cognitive tests. There was a correlation between age and the following week-4 tests: HVLT-R total score (r = −0.3, P = 0.02), HVLT-R total recall subscale (r = −0.4, P = 0.007), Trails A (r = 0.4, P = 0.002), and Trails B (r = 0.4, P = 0.004). A linear regression model found that HVLT-R total score decreased by 0.372 points for each increased year of age.
Conclusions: In women aged 50 years and older, there were no changes in cognitive function between those taking trospium and placebo. Cognitive function was correlated with age.
Outcomes of Rectovaginal Fistula Repair Objectives: Rectovaginal fistulae (RVF) often represent surgical challenges, and treatment must be individualized. We describe outcomes after primary surgical repair stratified by fistula etiology and surgical approach.
Methods: This retrospective cohort study included women who underwent surgical management of RVF at a tertiary care center between July 1, 2001 and December 31, 2013. Cases were stratified according to the following etiology: cancer (RVF-C), inflammatory bowel disease or infectious (RVF-I), and other (RVF-O). Patients with prior surgical treatment of RVF were excluded. Surgical approaches included local (seton, plug), transvaginal or endorectal, abdominal, diversion alone, or definitive (completion proctocolectomy with permanent colostomy or pelvic exenteration). Recurrence-free survival was estimated using the Kaplan-Meier method, and comparisons between subgroups were evaluated based on fitting Cox proportional hazards models. Censoring occurred at last relevant clinical follow-up. Factors contributing to recurrence-free survival were evaluated including age, body mass index, smoking status, fistula etiology, ileostomy, and surgical approach.
Results: During the study period, 107 women underwent surgical repair of RVF. The most common fistula etiology was RVF-I (54.2%), followed by RVF-O (23.4%), and RVF-C (22.4%). Ninety-four women underwent fistula repair by the local (29.9%), transvaginal/endorectal (25.2%), abdominal approach (19.6%), or diversion alone (13.1%), whereas 13 underwent definitive surgery (12.2%). Recurrence-free survival was significantly different depending on surgical approach (P < 0.001), but not etiology (P = 0.71). Recurrence-free survival (95% confidence interval) at 1 year after surgery was 35.2% (21.8%–56.9%) for the local approach, 55.6% (37.0%–83.3%) for the transvaginal or endorectal approach, 95% (85.9%–100%) for the abdominal approach, and 33.3% (15%–74.2%) for those with diversion only.
Conclusions: Recurrence rates after RVF repair are high and did not differ by fistula etiology. Abdominal repair of RVF had significantly fewer recurrences.
Readmission and Reoperation After Surgery for Pelvic Organ Prolapse Objectives: We aimed to determine the rates of readmission and reoperation for patients undergoing surgery for pelvic organ prolapse (POP).
Methods: The American College of Surgeons National Surgical Quality Improvement Program Participant User File was used to select all surgeries performed for POP from 2012 through 2014. The cohort was then reviewed for unplanned readmissions and unplanned reoperations within 30 days of POP surgery. Patient and procedural factors associated with readmission or reoperation were compared using χ2 analyses and Student t test. Multivariable logistic regression determined independent risk factors for both readmission and reoperation.
Results: A total of 23,419 patients underwent surgery for POP. Of these, there were 435 (1.9%) readmissions and 341 (1.5%) reoperations within 30 days. Median numbers of days from index procedure to readmission or reoperation were 9 and 8 days, respectively. Those who were readmitted had higher American Society of Anesthesia (ASA) scores, longer operative times, and longer lengths of stay than those who were not readmitted (all P < 0.001). Patients who underwent unplanned reoperation also had higher ASA scores, longer operative times, and longer lengths of stay than those who did not undergo reoperation (all P < 0.01). The most common reasons for readmission were surgical site infection (SSI) (19.3%) and non-SSI (15.9%). The most common reason for reoperation was urologic (27.6%) such as cystoscopy or stent placement.
Conclusions: Readmission and reoperation rates are relatively low for patients undergoing surgery for POP. Infection, both SSI and non-SSI, accounted for 35.2% of readmissions. Identification of ASA score of 3 or higher, longer total operating time, and increased length of stay is associated with unplanned readmission and reoperation.
Increasing Age Is a Risk Factor for Decreased Postpartum Pelvic Floor Strength Objectives: This study aimed to determine factors associated with decreased pelvic floor strength (PFS) after the first vaginal delivery (VD) in a cohort of low-risk women.
Methods: This is a secondary analysis of a prospective study examining the risk of pelvic floor injury in a cohort of primiparous women. All recruited participants underwent an examination, three-dimensional ultrasound and measurement of PFS in the third trimester and repeated at 4 weeks to 6 months postpartum using a perineometer.
Results: There were 84 women recruited for the study, and 70 completed the postpartum assessment. Average age was 28.4 years (standard deviation, 4.8). There were 46 (66%) subjects with a VD and 24 (34%) with a cesarean delivery who labored. Decreased PFS was observed more frequently in the VD group compared with the cesarean delivery group (68% vs 42%, P = 0.03).
In modified Poisson regression models controlling for mode of delivery and time of postpartum assessment, women who were aged 25 to 29 years (risk ratio = 2.80, 95% confidence interval, 1.03–7.57) and 30 years and older (risk ratio = 2.53, 95% confidence interval, 0.93–6.86) were over 2.5 times more likely to have decreased postpartum PFS compared with women younger than 25 years.
Conclusions: In this population, women aged 25 years and older were more than twice as likely to have a decrease in postpartum PFS.
Two-Dimensional and Three-Dimensional Transperineal Ultrasound Findings in Women With High-Pressure Voiding After Midurethral Sling Placement Objectives: The aim of this study was to evaluate dynamic two-dimensional (2D) and 3D transperineal pelvic ultrasound findings with urodynamic studies in women with lower urinary tract symptoms after midurethral sling placement.
Methods: On 2D images, the sling position, and on 3D imaging the sling angle, urethral diameter, urethral height, and urethral cross sectional area were recorded with and without Valsalva. Patients were categorized into 3 groups based on 2D imaging: group 1—at rest, the sling lies parallel to the urethral lumen, and during Valsalva, the sling becomes C shaped; group 2—both at rest and during Valsalva, the sling runs parallel to the urethral lumen; group 3—at rest, the sling is C shaped, and during Valsalva, this curved shape is maintained. For analytical purposes, G3 was compared with G1+2. Multiple logistic regressions were used to evaluate the association between transperineal pelvic ultrasound and urodynamic study.
Results: Univariate analyses to examine the relationships between high-pressure voiding, and each variable revealed that Valsalva sling angle, G3 versus G1+2, and sling position as percentage of the urethral length yielded significant findings (odds ratio, 95% confidence interval, P value for each, respectively: 1.037, 1.001–1.074, 0.04; 11.67, 2.116–64.31, 0.004; and 0.952, 0.911–0.994, 0.02). When including G3 versus G1+2, Valsalva sling angle, and percentage into the regression model, we concluded that there was only statistically significant association between groups and high-pressure voiding (odds ratio, 6.85; 95% confidence interval, 1.12–42.04; P = 0.03).
Conclusions: Transperineal ultrasound can help to predict women with high-pressure voiding after midurethral sling and thus may aid in the diagnosis of partial bladder outlet obstruction.
Association Between Obesity and Perioperative Morbidity in Open Versus Laparoscopic Sacrocolpopexy Objectives: The aim of this study was to compare differences in 30-day perioperative morbidity and mortality for women undergoing open sacrocolpopexy (OSCP) versus laparoscopic sacrocolpopexy (LSCP) across all body mass index (BMI) groups and between patients of ideal versus elevated BMI (includes overweight, obese, and morbidly obese).
Materials and Methods: Data for this retrospective review were obtained from the American College of Surgeons-National Surgical Quality Improvement Project database using current procedural terminology. All women older than 18 years who underwent an OSCP or LSCP from 2005 to 2013 were included. Patients were divided into 4 BMI (weight [kg]/[height (m)]2) subgroups: (1) less than 25, (2) 25 to 29.9, (3) 30 to 39.9, and (4) 40 or greater. The data were analyzed using Student t or χ2 test and Fisher exact test.
Results: A total of 4894 women underwent an OSCP or LSCP. Shorter operative times were observed with OSCP (P < 0.05) in all BMI groups except morbidly obese patients. Compared with patients of ideal body weight, overweight and obese patients had significantly longer operation times during LSCP (P < 0.05), a difference that was not observed during OSCP. For all BMI subgroups, the length of hospital stay was significantly shorter for LSCP (1 [1–1]) versus OSCP (2 [2–3]) (P < 0.05). Statistically significant increases in the rate of superficial surgical site infections were observed in OSCP in patients of both ideal and overweight BMIs (P < 0.05).
Conclusions: Obesity increases the operative time during LSCP. For patients in all BMI groups, LSCP offers the benefit of shorter hospital stays when compared with OSCP.
Modifiers of Response to Treatment With Fesoterodine for Urgency-Predominant Urinary Incontinence in a Randomized Controlled Trial Objective: The aim of this study was to identify clinical and demographic characteristics that moderate response to treatment with fesoterodine among women with a diagnosis of urgency-predominant urinary incontinence.
Methods: A multicenter, double-blinded, 12-week randomized controlled trial of pharmacologic therapy for urgency-predominant urinary incontinence in community-dwelling women diagnosed by the 3-item Incontinence Questionnaire (3IQ) was previously performed. Participants (N = 645) were randomized to fesoterodine therapy (4–8 mg daily; n = 322) or placebo (n = 323). Urinary incontinence was assessed by 3-day voiding diaries. In this secondary analysis, a “responder” was defined as reduction of 50% or greater in overall incontinence episode frequency compared with baseline. Clinical and demographic characteristics that may moderate treatment response were assessed by testing for interaction between characteristics and intervention in logit models of responders, adjusting for clinical site.
Results: Participants’ ages were a mean of 56 (SD, 14) years, 68% were white race, and they had a mean of 3.9 (SD, 3.0) urgency incontinence episodes per day. There were no baseline differences in demographic, clinical, or incontinence characteristics between treatment and placebo groups or between responders and nonresponders. There was an increase in the proportion of responders to fesoterodine with increasing age (P = 0.04) and parity (0.04) and among married women (P = 0.03), but no effect modification was observed by race/ethnicity, body mass index, education, employment status, or alcohol or tobacco use.
Conclusions: In ambulatory women with urgency-predominant urinary incontinence, older age, being married, and higher parity significantly moderated and potentiated the effects of pharmacologic therapy on incontinence frequency. This study identifies certain populations who may have increased responsiveness to treatment with antimuscarinic therapy and may be used to inform and guide future therapy.
The K-Technique: A Novel Technique for Laparoscopic Apical Suspension Using Barbed Sutures Objectives: Hysterectomy is among the most common gynecologic procedures performed for women, second only to cesarean sections, and the proportion of it performed laparoscopically continues to increase. Addressing apical support at the time of the hysterectomy is crucial to minimizing the risk of posthysterectomy prolapse. Barriers to addressing apical support include the lack of experience in laparoscopic suturing and knot tying that require advanced skills and dexterity. The K-technique is a novel modification of the uterosacral ligament suspension procedure using the knot-less barbed suture technology, rendering suturing easier and quicker to perform.
Method: The vaginal cuff epithelium is closed with 2 unidirectional barbed sutures that are started at the lateral fornices and ran until the midsection. The same sutures will then serially purchase the anterior and posterior vaginal endopelvic fascia and the midsegment of the uterosacral ligament. Two more passes are thrown through the same structures, yet farther laterally, back and forth. A video illustration of the procedure is attached.
Results: Eighteen patients underwent the procedure with no urinary tract injuries documented by cystoscopy and no postoperative morbidity documented during the 6-week postoperative follow-up period. Limited short- and long-term follow-up data are reassuring, but more will be needed to confirm the efficacy of barbed sutures in prolapse repair.
Conclusions: The K-technique combines the conventional uterosacral ligament suspension concept with the ease, effectiveness, and safety of barbed sutures. The technique might aid the surgeon to add the apical vaginal support when indicated.
In Vivo Ultrasound Characteristics of Vaginal Mesh Kit Complications Objective: The objective of this study was to investigate the ultrasound characteristics of vaginal mesh in women with vaginal mesh complications.
Methods: This was a cross-sectional study of women presenting with extrusion complications from vaginal mesh kit for prolapse at our tertiary care center between years 2009 and 2014. We included women who concurrently underwent a 3-dimensional endovaginal ultrasound (EVUS) as part of the clinical evaluation. We excluded women with incomplete charts and poor imaging quality. Subjects were categorized by the presence or absence of associated pelvic pain. Based on ultrasound findings, we compared the location of mesh, the appearance of mesh pattern (flat, folding, prominence, convoluted), and other EVUS characteristics of mesh.
Results: Forty-six women with vaginal mesh complications and good image quality were included. When comparing mesh length between posterior and anterior compartments, the posterior meshes were significantly longer than the anterior meshes (42.1 [SD, 11.9] mm vs 25.8 [SD, 9] mm; P < 0.0001) and more often associated with pain. In the posterior compartment, the mean mesh length seen on EVUS was significantly longer in women with pain than in women without pain (46.5 [SD, 9] mm vs 31.8 [SD, 12.1] mm; P = 0.0001). There was also a higher proportion of a “flat” mesh pattern, 14 (58.3%) of 25, in the posterior compartment associated with the presence of pain (P = 0.013). In the posterior compartment, a smaller distance between the distal edge of the mesh and the anal sphincter was significantly associated with the presence of pain (8 mm [0–37] vs 21 mm [8–35], P = 0.024). In both compartments, the EVUS had 100% sensitivity for detection of mesh extrusions.
Conclusions: In this population of patients presenting with mesh complications, the posterior meshes were more often visualized as a “flat” pattern with a higher frequency of pain. Mesh complications of the anterior compartment had a higher frequency of folding and shrinkage.
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