Female Pelvic Medicine & Reconstructive Surgery - Current Issue

Surgical Innovation and the US Food and Drug Administration No abstract available

Randomized Controlled Trial to Assess the Impact of Intraurethral Lidocaine on Urodynamic Voiding Parameters Objectives The aim of the study was to determine whether intraurethral anesthesia decreases voiding efficiency (VE; voided volume/(voided volume + residual volume)) and impacts other urodynamic parameters in healthy female volunteers during urodynamic studies. Methods This was a randomized double-blind placebo-controlled study of asymptomatic women aged 18 to 60 years. Subjects completed a visual analog scale and baseline questionnaires to assess pain and lower urinary tract symptoms, respectively. They performed an uninstrumented baseline uroflow, followed by physiologic filling to 250 mL or greater. Subjects were randomized to receive 5 mL of intraurethral aqueous gel or 2% lidocaine gel and then underwent a second uninstrumented uroflow. They then completed complex cystometry, urethral pressure profilometry, and pressure-flow studies. Results Twenty-three randomized subjects (12 placebo, 11 lidocaine) were included. Baseline uroflow VE was similar between the placebo and lidocaine groups. After study drug administration, VE was not different between groups (89.3 [85.9–93.9] vs 89.5 [82.5–91.7], P = 0.74). There were also no differences between groups in visual analog scale scores, sensation during cystometry, maximum urethral closure pressure, or micturition parameters (maximum detrusor pressure and detrusor pressure at maximum flow). The placebo group had a lower percentage of interrupted flow pattern (0% vs 36%, P = 0.02) and a lower rate of increased electromyographic activity during micturition (25% vs 73%, P = 0.02). Conclusions In this pilot study of 23 asymptomatic women, intraurethral administration of lidocaine did not decrease VE compared with placebo. The lidocaine group had a greater percentage of interrupted flow patterns and increased electromyographic activity during micturition.

Long-Term Outcomes After Overlapping Sphincteroplasty for Cloacal-Like Deformities Objective The aim of this study was to report subjective, long-term outcomes and describe patient demographics, presenting symptoms, perioperative management, and complications after overlapping sphincteroplasty repair for chronic fourth-degree lacerations (cloacal-like deformities). Methods In this retrospective study, hospital records were reviewed for women who underwent overlapping anal sphincteroplasty for a cloacal-like deformity of the perineum at a single institution from 1996 to 2013. Details including patient demographics, presenting symptoms, perioperative management, and complications were abstracted from the medical record. As a follow-up, subjects were contacted by telephone and were administered the validated Modified Manchester Health Questionnaire to assess anal continence status and anal incontinence-related quality of life since the time of surgery. Results Of 57 women who underwent an anal sphincteroplasty within the study period, 29 met inclusion criteria. Median parity was 3 (range, 1–7) and 24.5% reported a history of forceps or vacuum-assisted vaginal delivery. Presenting symptoms included fecal incontinence (58.6%), flatal incontinence (41%), sexual dysfunction (20.7%), and poor body self-image (3.4%). Thirteen (45%) women could be contacted by telephone and all agreed to participate. Overall, 46.2% of the 13 women who completed the Modified Manchester Health Questionnaire reported some form anal of incontinence, whereas 53.8% reported complete continence at a mean follow-up of 7.0 ± 3.6 years. Perioperative morbidity was uncommon, and postoperative antibiotics were used in 75.9% of cases for a median duration of 8.8 ± 3.3 days. Conclusions Perioperative morbidity after overlapping sphincteroplasty for cloacal-like deformities after obstetrical injury is rare. Although long-term complete anal continence may be difficult to achieve in all cases, good quality of life measures and low symptom severity were noted at a mean interval of 7 years after surgery.

Patients’ Knowledge of and Attitude Toward Robotic Surgery for Pelvic Organ Prolapse Objectives Robotic sacrocolpopexy for pelvic organ prolapse (POP) has increased, along with marketing and media coverage. It is unknown whether this exposure influences patients’ opinions on POP repair. This study describes the preference for and knowledge of robotic surgery in women with POP. Methods We performed a cross-sectional survey of new patients presenting with POP at 7 academic sites. Subjects had no prior surgical counseling. A self-administered questionnaire was designed to investigate robotic surgery knowledge, preference, and exposure. Subjects expressed their preferred route of POP repair (robotic, vaginal, abdominal, laparoscopic, or no preference). Knowledge was determined by the number of correctly answered questions (range, 0–7). Perception of robotic surgery was compared with other surgical routes. Results One hundred seventy-six subjects were included. Most had no surgical preference (66.3%), whereas 27.3% preferred nonrobotic and 6.4% preferred robotic routes. The mean knowledge score was 2.3 (SD, 1.7). Women preferring robotic surgery were more likely to view it as faster than laparoscopic surgery (P < 0.001). These same subjects did not perceive any advantages for robotic surgery related to blood loss, pain, and organ injury (P > 0.05). Most reported no prior exposure to robotic surgery information (56.2%) or advertisements (65.2%). Those with prior exposure most frequently obtained information via the Internet and encountered hospital advertisements. Conclusions The majority of women with POP reported no preference for robotic approach to POP surgery. Knowledge about robotic surgery was low, even among subjects who expressed preference. Comprehensive counseling may help patients make informed decisions even when surgical preferences exist.

Does the Vaginal Flora Modify When a Synthetic Mesh is Used for Genital Prolapse Repair in Postmenopausal Women? A Pilot, Randomized Controlled Study Objective The vaginal flora from postmenopausal women with pelvic organ prolapse (POP) is different from younger women. We hypothesized that the decision of a surgical route using a mesh would modify the vaginal flora. The purpose of this study was to analyze the vaginal flora from postmenopausal women that were submitted to abdominal sacrocervicopexy or vaginal sacrospinous fixation. Methods A pilot, randomized controlled study with 50 women aged 55 to 75 years (n = 25; abdominal sacrocervicopexy + subtotal hysterectomy; n = 25 vaginal sacrospinous fixation + vaginal hysterectomy) was performed. A polyvinylidene mesh was used in both arms. The vaginal content analysis was collected before and 60 days after the surgery. The type of flora, the presence of lactobacilli/leukocytes, and the Nugent criteria were analyzed. Results Most of the women were white (80%), with at least 1 comorbidity (69.9%), did not present sexual activity (60%), and presented advanced stage 4 POP. Two thirds of women presented a type 3 flora, and half of them did not present lactobacilli (48.3%). About the Nugent criteria, 51.7% presented normal flora, 46.6% found altered flora, and 1.7% had bacterial vaginosis. There were no differences about the type of flora (P = 1), number of lactobacilli (P = 0.9187), Nugent criteria (P = 0.4235), inflammation (P = 0.1018), and bacterial vaginosis (P = 0.64) before and after surgery in both groups. Conclusions In this pilot study, the use of synthetic mesh by vaginal or abdominal route did not affect the vaginal flora in postmenopausal women operated on by POP surgery.

Effectiveness of Assessing Ureteral Patency Using Preoperative Phenazopyridine Objectives The aims of this study were to determine the efficacy of phenazopyridine when used intraoperatively to assess ureteral patency and to investigate factors that may influence its efficacy. Methods This is a retrospective chart review performed at the Olive View–UCLA Medical Center, a Los Angeles County teaching hospital, from January 2014 through July 2016. Patients undergoing cystoscopy at the time of gynecologic surgery were identified via department case logs. All women receiving preoperative oral phenazopyridine were included. If ureteral flow was unable to be visualized with phenazopyridine alone, the medication was deemed ineffective, and sodium fluorescein was given intraoperatively. Patients were divided into a phenazopyridine effective or phenazopyridine ineffective group. Patient demographics, renal function, intraoperative fluids and urine output, estimated blood loss, timing and dose of medication administration, and complications were gathered from the chart and compared between groups using Fisher exact test, 2-sample t test, Wilcoxon test, and logistic regression for multivariable analysis. P < 0.05 was determined to be significant. Results Preoperative phenazopyridine was effective in 190 (91.8%) of 207 patients. It was ineffective in 17 patients who then required intraoperative sodium fluorescein. The group in which phenazopyridine was effective was more likely to have been given a 200-mg (vs 100-mg) dose (P = 0.02) and had lower intraoperative urine output (median, 450 vs 800 mL; P = 0.002). Conclusions Preoperative oral phenazopyridine is effective in more than 90% of cases to detect during gynecologic surgery. A higher phenazopyridine dose and lower intraoperative urine output were associated with increased efficacy.

Volume at First Leak Is Associated With Sling Failure Among Women With Stress Urinary Incontinence Introduction Stress urinary incontinence at a low bladder volume is a clinically observed phenomenon that is not well studied with regard to treatment outcomes. The primary aim of our study was to determine if the volume at first leak is associated with sling outcome. Methods This is a retrospective cohort study evaluating whether urodynamic stress urinary incontinence observed at low volumes is associated with sling failure using the Synthetic Derivative database. Sling failure was defined as (1) undergoing a subsequent surgery for stress incontinence (eg, urethral bulking agent, repeat sling) or (2) leakage that was subjectively worse or unchanged from baseline. Sling success was defined as subjective improvement in incontinence or being dry. Intrinsic sphincter deficiency was defined as maximum urethral closure pressure 20 cm H20 or less or abdominal leak point pressure less than 60 cm H20. Results Outcome data were available for 168 of 206 women who underwent a sling after urodynamic testing from 2006 to 2014. Of the 168 women, 80 were transobturator, 79 were retropubic, 8 lacked data regarding the approach to the midurethral sling, and 1 was an autologous pubovaginal sling. Similar failure rates were seen for transobturator (10%) and retropubic slings (7.6%). Preoperative urodynamic parameters, such as cystometric capacity and intrinsic sphincter deficiency, were similar among failed and successful slings. For every additional 50 mL in bladder volume at first leak (SUIvol), there was a 1.6 increased odds of having a successful sling (odds ratio, 1.576; 95% confidence interval, 1.014–2.450; P = 0.04). There was no statistically significant association between maximum urethral closure pressure, abdominal leak point pressure, body mass index, age, sling type, or whether a prior anti-incontinence procedure had been performed and sling success. Conclusions Bladder volume at first leak is a strong predictor of sling failure.

Teaching Vaginal Hysterectomy via Simulation: Creation and Validation of the Objective Skills Assessment Tool for Simulated Vaginal Hysterectomy on a Task Trainer and Performance Among Different Levels of Trainees Objectives The use of simulation-based education to train surgeons is widely accepted. Although many authors describe the use of an Objective Skills Assessment Test (OSAT) to assess performance of various surgical procedures, there is a paucity of research on use of this modality to evaluate vaginal surgery skills. We created a vaginal hysterectomy procedure-specific checklist (PSC) to complete the OSAT (which is composed of a PSC and a global rating scale [GRS]). The primary objective of this study is to evaluate the performance of a novel evaluation strategy for vaginal hysterectomy using an OSAT combining PSC and GRS. Methods This is a descriptive prospective study from a single institution. After orientation to the model, participants were filmed performing vaginal hysterectomy. A blinded grader scored each subject using the PSC and GRS. Results Medical students, residents, fellows, and attendings performed vaginal hysterectomy on a simulated model. Mean PSC and GRS scores increased significantly with surgeon level of experience (P < 0.001). Procedure-specific checklist scores significantly correlated with GRS scores (P < 0.001). Conclusions The vaginal hysterectomy model and PSC have been studied across different surgeon levels using OSATs. Training programs should consider using this low-cost task trainer as a teaching tool.

The Association of Abdominal Striae With Pelvic Organ Prolapse Objective Our objective was to estimate the prevalence of abdominal wall striae among women with and without pelvic organ prolapse (POP) in a population with pelvic floor disorders. Methods This cross-sectional study included nonpregnant women with urinary incontinence and POP presenting to a tertiary urogynecology practice between December 2012 and August 2013. Participants completed a nonvalidated questionnaire about striae, and the degree of abdominal wall striae was quantified on physical examination. Baseline demographics, clinical characteristics, and Pelvic Organ Prolapse Quantification (POP-Q) measurements were recorded. Results One hundred thirty-two women were approached for participation, of which 110 (83%) completed study questionnaires. Of these 110, 59 had POP defined at POP-Q stages 2–4, whereas 51 had normal pelvic support, POP-Q stages 0–1. The mean (SD) age was 55.5 (12) years, and most (78/110) were sexually active. Women with POP were more parous than women without POP (median 2 vs 1, respectively; P = 0.03). However, there was no difference in medical comorbidities, smoking status, or steroid use between groups (P > 0.05). More women with POP reported striae (42/59 [71%] vs 23/51 [45%], P = 0.006) and had quantifiable abdominal wall striae compared with women with normal support (39/59 [66%] vs 22/51 [44%], P = 0.02). On multivariate logistic regression, women with POP were 2.5 times more likely to have striae compared with women without POP after adjusting for skin type and smoking status (odds ratio, 2.5; 95% confidence interval, 1.03–6.06; P = 0.04). Conclusion Women with POP are more likely to have striae compared with women without POP.

Orally Administered Combination of Hyaluronic Acid, Chondroitin Sulfate, Curcumin, and Quercetin in the Prevention of Postcoital Recurrent Urinary Tract Infections: Analysis of 98 Women in Reproductive Age After 6 Months of Treatment Objective The aim of this study is to assess the efficacy of orally administered combination of hyaluronic acid (HA), chondroitin sulfate (CS), curcumin, and quercetin for the prevention of postcoital recurrent urinary tract infection (UTI) in reproductive age women. Methods Ninety-eight consecutive patients in reproductive age affected by UTI were considered for the study. All 98 patients received a combination of HA, CS, curcumin, and quercetin two tablets per diem for the first month and one tablet every day for the next 5 months. We investigate recurrence of UTI with the Urinary Tract Infection Symptoms Assessment and the Pelvic Pain and Urinary Urgency Frequency. The quality of life and sexual function were valued using 36-Item Short Form Survey, Female Sexual Function Index, and the Female Sexual Distress Scale questionnaires. The same investigations were performed at the first visit and after 6 months of treatment. Results The symptoms associated with UTI significantly decreased after 6 months of treatment, in particular dysuria episodes diminished and number of voiding decreased (P < 0.0001). During the treatment period, only seven patients (7.1%) experienced a UTI recurrence, confirmed by positive urine culture with bacteriuria of greater than 105 colony forming units/mL. The Pelvic Pain and Urinary Urgency Frequency, Female Sexual Function Index, Female Sexual Distress Scale, and 36-Item Short Form Survey showed a statistically significant improvement after 6 months. Conclusions Oral administration of a combination of HA, CS, curcumin, and quercetin is a valid and well-tolerated nonantibiotic treatment for prevention of postcoital UTI in reproductive age women.