A Randomized Clinical Trial Comparing the Efficacy and Safety of 2% Versus 4% Chlorohexidine Gluconate for Surgical Preparation of the Vagina.

IMPORTANCE: There have been no studies comparing 2% and 4% chlorhexidine gluconate (CHX) for vaginal surgical site preparation despite both commonly being used. OBJECTIVES: The primary objective was to assess the noninferiority of 2% CHX versus 4% CHX to reduce bacterial contamination rates at 60 minutes after surgical preparation of the vagina. Secondary objectives were to assess differences in colony-forming units and the sensation of postoperative vaginal burning and pain. STUDY DESIGN: This is a single-blinded randomized controlled trial of women who underwent vaginal prolapse surgery. Study participants were randomized into 2 groups: 2% CHX versus 4% CHX. Two vaginal bacterial cultures were collected: (1) preoperatively before vaginal preparation and (2) intraoperatively at 60 minutes. A questionnaire on vaginal pain and burning was administered preoperatively and postoperatively. For our sample size, assuming that 2% CHX would have double the contamination rate of 4% CHX, 26 participants were needed per group to demonstrate noninferiority. RESULTS: Sixty-one women participated in the study. There were no differences in baseline demographics, length of surgery, or surgical procedures. For our primary outcome, the postpreparation contamination rates were 7% for 2% CHX versus 10% for 4% CHX, with a difference of 3% ( P = 0.52). This difference did meet the criteria for noninferiority. Secondary outcomes were not different between groups. CONCLUSIONS: Two percent CHX is noninferior to 4% CHX in reducing vaginal bacterial contamination at 60 minutes after vaginal surgical site preparation, with low rates of postpreparation contamination and vaginal discomfort.

Effect of BMI on clinical outcomes following minimally invasive sacrocolpopexy.

Our objective was to compare success and complication rates following minimally invasive sacrocolpopexy (SCP) based on body mass index (BMI). This is a retrospective cohort study of women who underwent laparoscopic or robotic SCP at one academic center from 2006 to 2016. Women were included if they had a postoperative pelvic organ prolapse quantification (POPQ) exam and subjective success documented. For our primary outcome, we compared composite success (POPQ stage ≤ I and report of no bulge symptoms) amongst three groups: normal weight (BMI ≤ 25), overweight (BMI 25-30) and obese (BMI ≥ 30) women. Secondary outcomes included intraoperative complications, 6 week postoperative complications, and sacrocolpopexy mesh exposure. Of the 431 women who met inclusion criteria, 140 (32%) had normal BMI (23 kg/m2; IQR 22, 24), 177 (41%) were overweight (27 kg/m2; IQR 26, 28), and 114 (26%) were obese (32 kg/m2; IQR 31, 36). Mean age was 60 ± 11 years, and most were Caucasian, with no differences in demographics or Charlson Comorbidity Index (CCI). Median length of follow-up was 49 weeks (IQR 9, 104), with similar follow-up for all groups. For our primary outcome, composite success was 72% overall, with no significant differences in composite success rates between groups. For secondary outcomes, there were no differences in the rates of perioperative complications but obese women had a 2.8 increased risk of mesh exposure (p = 0.02). Obesity was not associated with differences in the success or peri-operative complication rates for SCP in our population, but was associated with mesh exposure.

The Impact of Age on Perioperative Complications After Minimally Invasive Sacrocolpopexy.

OBJECTIVE: Our aim was to compare perioperative complications between older (≥65 years), middle-age (55-64 years), and younger (<55 years) women after minimally invasive sacrocolpopexy (SCP). METHODS: This retrospective cohort study included women undergoing SCP from 2006 to 2016 at a single academic center. Our primary outcome was the rate of perioperative complications (intraoperative and postoperative within 6 weeks of surgery), between groups. Secondary outcomes included readmission and reoperation rates. RESULTS: There were 440 consecutive participants: 159 (36.1%) older, 160 (36.4%) middle-age, and 121 (27.5%) younger women. The overall intraoperative complication rate from SCP was 9.1%, with the most common being cystotomy (5.0%) and vaginotomy (1.8%). There were no differences in intraoperative complications between groups. Urinary tract infection (10.9%) and port-site cellulitis (3.4%) were the most common postoperative complications. For our primary outcome, younger women had a higher rate of postoperative complications compared with middle-age and older women (P < 0.001). There was no difference in postoperative complications between older and middle-aged women. In a multivariate regression controlling for comorbidity, body mass index, diabetes, smoking status, concomitant hysterectomy, and/or sling, younger women retained a higher rate of postoperative complications (odds ratio, 1.7 [1.2,2.2]). Rates of readmission (3.2%) and reoperation (0.7%) were also similar between groups. CONCLUSIONS: The rate of perioperative complications was low with no difference in intraoperative complications. Women under 55 had a higher rate of postoperative complications compared to women age 55 to 65 years and those older than 65 years. Our results suggest that it is reasonable to offer SCP to women older than 65 years.

Moving On: How Many Women Opt for Surgery After Pessary Use for Prolapse?

OBJECTIVE: Our primary objective was to evaluate the proportion of women who underwent surgery after successful pessary fitting for pelvic organ prolapse (POP). Our secondary objectives were to assess when surgery occurs and to evaluate factors associated with choosing surgery as compared to continuing with a pessary. METHODS: Our study population included women successfully fitted with a pessary for POP 1/1/12 and 12/31/16. We excluded non-English-speaking women and those who used pessary only as a bridge until surgery. We evaluated events occurring after a successful fitting, including whether women (1) continued pessary use, (2) underwent surgery, or (3) discontinued pessary without surgery. Our primary outcome was the proportion of women who opted for surgery after a successful pessary fitting for POP. We also assessed the median time to surgery and compared women who underwent surgery with those who continued with a pessary to assess variables associated with surgery. RESULTS: Of the 444 women with POP who were successfully fitted with a pessary and met inclusion criteria, 137 (31%) ultimately underwent surgery. The median time to surgery was 10 months (interquartile range, 4-18), with 59% having surgery within 1 year, and 89% within 2 years. In a logistic regression analysis controlling for age in decades, advanced POP stage, and Charlson Comorbidity Index, younger age remained significantly associated with surgery (odds ratio, 0.77, 95% confidence interval, 0.62-0.95; P = 0.02). CONCLUSIONS: Among women successfully fitted with a pessary for POP, one third ultimately underwent surgery, with approximately 60% of these women undergoing surgery within the first year and 90% within 2 years.

A narrative review of the epidemiology, diagnosis, and treatment of latent stress urinary incontinence.

AIMS: To review the current literature on the development of latent stress urinary incontinence (SUI) or SUI that occurs following pelvic organ prolapse therapy in patients who were continent prior to therapy. To make recommendations on how to best evaluate and manage patients with pelvic organ prolapse who are continent. METHODS: This is a narrative review using Google scholar and cross referencing identified manuscripts. We used the British Medical Journals grading of literature to assign letter grades to level of statements and recommendations. RESULTS: The literature suggest about 40% of women with advanced pelvic organ prolapse who are continent will develop SUI after surgery to correct their pelvic organ prolapse. Reduction cough stress testing can help identify those patients at risk to develop SUI with a PPV of 60%. Reduction cough stress testing is best done using large rectal swabs or scopettes. The literature on how to best manage patients with advanced pelvic organ prolapse and are continent to avoid latent SUI is mixed and the best recommendations are based on sound literature that is incomplete. CONCLUSIONS: Understanding that latent SUI is a potential complication in any subject with advanced pelvic organ prolapse is necessary to pre-operative counseling. Deciding on the best management strategy is not clear cut and therefore should involve patient input in the decision making process.

Defining normal apical vaginal support: a relook at the POSST study.

INTRODUCTION AND HYPOTHESIS: The purpose of this study is to reanalyze data from the original 2005 Pelvic Organ Support Study (POSST) data set to define normal values for apical Pelvic Organ Prolapse Quantification (POP-Q) points C and D and total vaginal length (TVL) in an asymptomatic population of women. METHODS: In this retrospective observational data-set review, patient were >18 years presenting for annual gynecologic exams to six centers in the United States. Data included demographics, questions about prolapse symptoms, and POP-Q points. Means and standard deviations were determined for each POP-Q point in the total population. RESULTS: The data set comprised 1011 women; 59 were excluded because they met criteria for having POP or were missing data. This left 948 for study. Mean age of our study population was 42 ± 14 years, and 45.6% were white, 25.1% black, and 25.2% Hispanic. One hundred fifty-six had a prior hysterectomy. Mean values with standard deviations (SD) for POP-Q values are as following: point C (vaginal cuff) -7.3 ± 1.5 cm, point C (cervix) -5.9 ± 1.5, point D -8.7 cm ± 1.5 cm, TVL (no hysterectomy) 9.8 cm ± 1.3 cm, and TVL (hysterectomy) 8.9 cm ± 1.5 cm. CONCLUSIONS: This data suggests normal values for POP-Q apical points in a population of patient with annual gynecological exams.

Standing Vs Supine; Does it Matter in Cough Stress Testing?

OBJECTIVES: The aim of this study was to compare the sensitivity of cough stress test in the standing versus supine position in the evaluation of incontinent females. METHODS: We performed a prospective observational study of women with the chief complaint of urinary incontinence (UI) undergoing a provocative cough stress test (CST). Subjects underwent both a standing and a supine CST. Testing order was randomized via block randomization. Cough stress test was performed in a standard method via backfill of 200 mL or until the subject described strong urge. The subjects were asked to cough, and the physician documented urine leakage by direct observation. The gold standard for stress UI diagnosis was a positive CST in either position. RESULTS: Sixty subjects were enrolled, 38 (63%) tested positive on any CST, with 38 (63%) positive on standing compared with 29 (28%) positive on supine testing. Nine women (15%) had positive standing and negative supine testing. No subjects had negative standing with positive supine testing. There were no significant differences in positive tests between the 2 randomized groups (standing first and supine second vs. supine first and standing second). When compared with the gold standard of any positive provocative stress test, the supine CST has a sensitivity of 76%, whereas the standing CST has a sensitivity of 100%. CONCLUSIONS: The standing CST is more sensitive than the supine CST and should be performed in any patient with a complaint of UI and negative supine CST. The order of testing either supine or standing first does not affect the results.

Enhanced expression of mast cell growth factor and mast cell activation in the bladder following the resolution of trinitrobenzenesulfonic acid (TNBS) colitis in female rats.

AIMS: Chronic pelvic pain disorders often overlap. We have shown that acute colonic irritation can produce acute irritative micturition patterns and acutely sensitize bladder afferent responses to mechanical and chemical stimuli. We hypothesize that with time, colonic irritation can lead to neurogenic changes in the bladder and the development of chronic bladder sensitization. METHODS: Micturition patterns were measured in rats 60-90 days after the induction of trinitrobenzenesulfonic acid (TNBS) colitis in the resolution phase of this model. Total and activated mast cells (MCs) were quantified in the bladder, while mRNA levels of stem cell factor (SCF; a.k.a. MC growth factor) and nerve growth factor (NGF; a MC and nociceptive C-fiber stimulator) were quantified in the bladder and L6-S1 dorsal root ganglia (DRG). RESULTS: Following intra-rectal TNBS, voiding volume was reduced (P < 0.005), while voiding frequency was increased (P < 0.05), both by approximately 50%. Furthermore, both the percentage and density of activated bladder MCs were significantly elevated (P < 0.05), although total MC counts were not statistically increased. At the molecular level, urinary bladder SCF expression increased twofold (P < 0.005), as did NGF (P < 0.01), while L6-S1 DRG levels were not significantly elevated. CONCLUSIONS: Chronic cystitis in the rat as evidenced by changes in micturition patterns and the recruitment of activated MCs can occur during the resolution phase of TNBS colitis. These changes, of which MCs may play an important role, appear to be maintained over time and may occur via stimulation of convergent pelvic afferent input resulting in the upregulation of neurotrophic factors in the target organ.