Perioperative outcomes following pelvic floor reconstruction in women with hereditary disorders of connective tissue: a retrospective cohort study.

INTRODUCTION AND HYPOTHESIS: Women with hereditary disorders of connective tissue (HDCT) are at increased risk of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). We hypothesized that patients would have increased incidence and severity of perioperative complications up to 6 weeks after surgeries for POP/SUI. Secondary objectives were to compare pre- and post-operative pelvic floor symptoms and anatomical support as well as pelvic floor disorder recurrence. METHODS: In this multi-center retrospective cohort study, we identified patients with HDCTs by patient history and ICD-9 codes over an 11-year period. Controls without HDCTs were matched 2:1 to the primary POP or SUI procedure and surgeon. Demographic characteristics, perioperative pelvic floor information and complications were collected. A sample size of 65 HDCT patients and 130 controls was calculated to detect a 20% difference in complications with 80% power and alpha of 0.05. RESULTS: We identified 59 HDCT patients and 118 controls. Of the women with HDCTs, 49% had Ehlers-Danlos, 22% joint hypermobility syndrome, 15% Marfan syndrome, and 14% had others. Compared with controls, HDCT patients had more total perioperative complications (46% vs 22%, p = 0.002); an age-adjusted relative risk of complications was 1.4 (CI 0.7-2.6). HDCT patients had more Clavien-Dindo grades I and II complications (p = 0.02, 0.03) and more hospital readmissions (14% vs 3%, p = 0.01) than controls. There was no difference in the incidence of specific complications nor was there a difference in recurrence of POP (10%) or SUI (11%) between groups. CONCLUSIONS: Patients with HDCTs had more Clavien-Dindo grade I and II complications following pelvic floor reconstructive surgery and more readmissions.

A Cost Analysis of Icon Reusable Underwear Versus Disposable Pads for Mild to Moderate Urinary Incontinence.

OBJECTIVE: The objective of this study was to perform a cost analysis assessing the economic feasibility of reusable underwear as alternative for disposable pads for women with mild to moderate urinary incontinence. METHODS: A consumer-perspective cost analysis was performed with the following assumptions: (1) consumers have mild to moderate urinary incontinence and use 2 pads per day (PPD); (2) consumers have a 2-week supply of underwear; (3) there is no difference in laundering cost between 2 incontinence options; (4) there is no difference in use of labor/other accessories of care; (5) there is no difference in skin complaints/associated cost; (6) cost of products are nonfluctuant with time; and (7) all incontinence products were purchased online. Sensitivity analyses were performed varying the longevity of underwear, price of regular underwear, price of pads, pads used per day, and shipping and handling. RESULTS: The total cost of disposable pads with regular underwear was US $392.40, whereas the cost of Icon underwear was US $380.80 over the course of 2 years. Icon costs less than using regular underwear with disposable pads as long as the cost of the regular underwear is at least US $2.17. Icon is economically inferior if the cost per pad is US $0.15 when using 3 PPD or if the cost per pad is US $0.24 when using less than 2 PPD. CONCLUSIONS: Reusable incontinence underwear can be an economically feasible alternative to disposable pads for light to moderate urinary incontinence after 2 years of use assuming underwear has a 2-year longevity and the consumer is using 2 PPD with regular underwear.

Antibiotic Prophylaxis During Catheter-Managed Postoperative Urinary Retention After Pelvic Reconstructive Surgery: A Randomized Controlled Trial.

OBJECTIVE: To estimate whether nitrofurantoin prophylaxis decreases the incidence of culture-documented urinary tract infection for women with catheter-managed urinary retention after pelvic reconstructive surgery. METHODS: This double-blind, placebo-controlled, randomized trial was conducted at five academic institutions. Women with urinary retention after surgery for prolapse or incontinence were randomized to oral nitrofurantoin 100 mg daily during indwelling or clean intermittent self-catheterization. The primary outcome was the incidence of symptomatic urinary tract infection within 6 weeks of surgery, confirmed by culture demonstrating more than 1,000 colony forming units per milliliter of uropathogenic bacteria. Secondary outcomes were adverse symptoms possibly attributable to nitrofurantoin and bacterial resistance to nitrofurantoin. A sample size of 154 would detect a decrease in urinary tract infection incidence from 33% to 13%, with 80% power, two-sided alpha of 0.05, and allow 10% dropout. RESULTS: Of 154 participants randomized from September 2016 to May 2018, 151 were eligible for analysis: 75 received nitrofurantoin, and 76 received placebo. Demographics were similar between groups. The indication for surgery was prolapse (46%), incontinence (20%), or a combination (34%). Participants were discharged with an indwelling catheter (58%) or performing self-catheterization (42%). Median duration of catheter use was 4 days (interquartile range 3-7). Thirteen women in the nitrofurantoin group and 13 women in the placebo group experienced urinary tract infection (17.3% vs 17.1%, P=.97, relative risk [RR] [95% CI] 1.01 [0.50-2.04]). Adverse symptoms possibly attributable to nitrofurantoin were common in both groups (68% vs 61%, P=.34, RR [95% CI] 1.12 [0.88-1.43]). Resistance to nitrofurantoin was identified in seven urine cultures, four among nitrofurantoin and three among placebo recipients. In total, 52 urine cultures were obtained to evaluate symptoms of urinary tract infection, and only 27 of 52 grew at least 1,000 cfu/mL of uropathogenic bacteria. CONCLUSION: Daily nitrofurantoin did not reduce the incidence of culture-proven urinary tract infection among women with catheter-managed urinary retention after pelvic reconstructive surgery. Culture confirmed urinary tract infection in only half of symptomatic episodes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02727322.

Randomized Cross-over Comparison of Icon™ Reusable Underwear to Disposable Pads for the Management of Mild to Moderate Urinary Incontinence.

OBJECTIVE: The objective of this study was to compare disposable pads to Icon™ reusable underwear for the management of urinary incontinence on dimensions of quality of life and product performance. METHODS: This randomized cross-over trial included women with mild to moderate urinary incontinence as defined by baseline responses to the International Consultation on Incontinence Questionnaire-Short Form. Excluded were patients who had fecal incontinence or an active urinary tract infection. Participants were randomized to 2 days of Icon™ underwear or disposable pads use and then completed another 2 days using the alternate product. Outcome measures were responses to Incontinence Quality of Life Instrument (I-QOL) and Product Performance Questionnaire for each product. RESULTS: Of the 70 women who were randomized, 52 completed the study. There was no significant difference between Icon™ underwear and disposable pads with regards to I-QOL total scores (66.2 ± 23.4 vs 65.5 ± 24.5, P = 0.71) or I-QOL subscores: avoidance and limiting behaviors (62.1 ± 24.4 vs 62.4 ± 25.0, P = 0.88), psychosocial impacts (74.4 ± 25.0 vs 73.4 ± 25.6, P = 0.51), and social embarrassment (57.8 ± 27.8 vs 56.1 ± 29.5, P = 0.43). Icon™ underwear scored significantly better than disposable pads on the Product Performance Questionnaire, with regards to overall impression (P = 0.0002), fit (P < 0.0001), discreteness (P < 0.0001), comfort when dry (P < 0.0001), comfort when wet (P = 0.0008), ability to keep skin dry (P = 0.0034), and kindness to skin (P < 0.0001). There was no difference between products in ability to hold urine without leaking (P = 0.40) or prevent odor when worn (P = 0.41). CONCLUSIONS: There was no difference in quality of life measures between Icon™ underwear and disposable pad users; however, Icon™ underwear was preferred on product performance.

Informed Consent for Reconstructive Pelvic Surgery.

Informed consent is the process in which a patient makes a decision about a surgical procedure or medical intervention after adequate information is relayed by the physician and understood by the patient. This process is critical for reconstructive pelvic surgeries, particularly with the advent of vaginal mesh procedures. In this article, we review the principles of informed consent, the pros and cons of different approaches in reconstructive pelvic surgery, the current legal issues surrounding mesh use for vaginal surgery, and tips on how to incorporate this information when consenting patients for pelvic floor surgery.