David R. Ellington

The Role of Vaginal Mesh Procedures in Pelvic Organ Prolapse Surgery in View of Complication Risk

Synthetic transvaginal mesh has been employed in the treatment of pelvic organ prolapse for more than a decade. As the use of these devices increased during this period so did adverse event reporting. In 2008, the Food and Drug Administration (FDA) Public Health Notification informed physicians and patients of rising concerns with the use of synthetic transvaginal mesh. Shortly thereafter and in parallel to marked increases in adverse event reporting within the Manufacturer and User Device Experience (MAUDE), the FDA released a Safety Communication regarding urogynecologic surgical mesh use. Following this report and in the wake of increased medical industry product withdrawal, growing medicolegal concerns, patient safety, and clinical practice controversy, many gynecologists and pelvic reconstructive surgeons are left with limited long-term data, clinical guidance, and growing uncertainty regarding the role of synthetic transvaginal mesh use in pelvic organ prolapse. This paper reviews the reported complications of synthetic transvaginal mesh with an evidence-based approach as well as providing suggested guidance for the future role of its use amidst the controversy.

Indications, Contraindications, and Complications of Mesh in Surgical Treatment of Pelvic Organ Prolapse

Women are seeking care for pelvic organ prolapse in increasing numbers and a significant proportion of them will undergo a second repair for recurrence. This has initiated interest by both surgeons and industry to utilize and design prosthetic mesh materials to help augment longevity of prolapse repairs. Unfortunately, the introduction of transvaginal synthetic mesh kits for use in women was done without the benefit of level 1 data to determine its utility compared with native tissue repair. This report summarizes the potential benefit/risks of transvaginal synthetic mesh use for pelvic organ prolapse and recommendations regarding its continued use.

The effect of obesity on fecal incontinence symptom distress, quality of life, and diagnostic testing measures in women

Introduction and hypothesisWeight-loss has been demonstrated to result in an improvement in fecal incontinence (FI) severity; however, there is a paucity of data addressing the differential impact of FI on the quality of life (QOL) and results of diagnostic testing across BMI categories. We wished to evaluate symptom distress, QOL, and diagnostic testing parameters among normal, overweight, and obese women with fecal incontinence.MethodsWomen undergoing evaluation for FI between 2003 and 2012 were identified. Participants completed validated, symptom-specific distress, impact, and general QOL measures including the Modified Manchester Questionnaire (MMHQ), which includes the Fecal Incontinence Severity Index (FISI), and the mental and physical component summary scores, MCS and PCS, respectively, of the Short Form-12. Anorectal manometry measures were also included. Multivariate regression analyses were performed.ResultsParticipants included 407 women with a mean age ± SD of 56 ± 13. Multivariate analyses revealed no differences in symptom-specific distress and impact as measured by MMHQ, MCS, and PCS across BMI groups; however, obese women had increased resting and squeeze pressures compared with normal and overweight BMI women (p < 0.0001 and p < 0.0001; p = 0.007 and p = 0.004 respectively).ConclusionsObese women with FI did not have more general impact and symptom-specific distress and impact on quality of life compared with normal and overweight women. Obese women with FI had higher baseline anal resting and squeeze pressures suggesting a lower threshold to leakage with pressure increases.

Preemptive analgesia for postoperative hysterectomy pain control: systematic review and clinical practice guidelines

Objective The objective of the study was to investigate the effectiveness of preemptive analgesia at pain control in women undergoing total abdominal hysterectomy. Data Sources Eligible studies, published through May 31, 2016, were retrieved through Medline, Cochrane Central Register for Controlled Trials, and Cochrane Database of Systematic Reviews. Study Eligibility We included randomized controlled trials with the primary outcome of pain control in women receiving a preemptive medication prior to total abdominal hysterectomy. Comparators were placebo, different doses of the same medication as intervention, or other nonnarcotic or narcotic medication. Study Appraisal and Synthesis Methods Study data were extracted by one reviewer and confirmed by a second reviewer. For each outcome we graded the quality of the evidence. Studies were classified by the type of medication used and by outcome type. Results Eighty‐four trials met eligibility, with 69 included. Among nonnarcotic medications, paracetamol, gabapentin, and rofecoxib combined with gabapentin resulted in improvements in pain assessment compared with placebo and other nonnarcotic medications. Patient satisfaction was higher in patients who were given gabapentin combined with paracetamol compared with gabapentin alone. Use of preemptive paracetamol, gabapentin, bupivacaine, and phenothiazine resulted in less narcotic usage than placebo. All narcotics (ketamine, morphine, fentanyl) resulted in improved pain control compared with placebo. Narcotics had a greater reduction in pain assessment scores compared with nonnarcotics, and their use resulted in lower total narcotic usage. Conclusion Preemptive nonnarcotic and narcotic medications prior to abdominal hysterectomy decrease total narcotic requirements and improve patient postoperative pain assessment and satisfaction scores.

Combined Tolterodine and Vaginal Estradiol Cream for Overactive Bladder Symptoms After Randomized Single-Therapy Treatment.

Objectives The aims of this study were to compare 12-week outcomes of single-therapy tolterodine (Detrol LA) extended release to intravaginal estrogen (Estrace) for overactive bladder (OAB) symptoms and characterize 24- and 52-week outcomes in women undergoing combined therapy. Methods A single-site randomized, open-label trial in women with urinary frequency, urgency, nocturia, and/or urgency urinary incontinence symptoms was performed. Fifty-eight participants were randomized to oral tolterodine extended release daily or intravaginal estradiol cream nightly for 6 weeks then twice per week. The primary outcome was change in Overactive Bladder Questionnaire (OAB-q) symptom bother score at 12 weeks. Secondary outcomes included the Health-Related Quality of Life Questionnaire (HRQL) of the OAB-q and a 3-day bladder diary. At 12 weeks, subjects were offered addition of the alternative therapy with follow-up at 24 and 52 weeks. Results There was no difference in symptom bother score improvement between the tolterodine and intravaginal estradiol groups baseline to 12 weeks (20.6 ± 21.7, −15.8 ± 23.3, respectively, P = 0.45). There was a significant within-group decrease in symptom bother score from baseline to 12 weeks (tolterodine, P < 0.0001, and intravaginal estradiol, P = 0.002). Secondary outcome improvement within groups was noted in the HRQL total, urinary incontinence episodes, and median voiding frequency (all P ⩽ 0.03) in the tolterodine group and in the HRQL total score (P = 0.03) in the intravaginal estradiol group, with no differences between groups. Combined therapy outcomes at 24 and 52 weeks compared with single therapy at 12 weeks revealed significant improvement in symptom bother score in the intravaginal estradiol + tolterodine group at 24 and 52 weeks (20.0 ± 23.9, P = 0.008; −16.7 ± 23.3, P = 0.02, respectively). Conclusions Significant within-group improvement in OAB-q symptom bother was noted in both the intravaginal estradiol and tolterodine groups for OAB symptoms, with no difference between groups. Greater improvement from 12-week single therapy to 24 and 52 weeks of combined therapy was noted in the group originally assigned to intravaginal estradiol. The role of combined medical therapy for OAB symptoms needs further investigation.

Outcomes of Surgery for Stress Urinary Incontinence in the Older Woman.

As population demographics continue to evolve, specifics on age-related outcomes of stress urinary incontinence interventions will be critical to patient counseling and management planning. Understanding medical factors unique to older women and their lower urinary tract conditions will allow caregivers to optimize surgical outcomes, both physical and functional, and minimize complications within this population.

Prevalence, Awareness, and Understanding of Pelvic Floor Disorders in Adolescent and Young Women.

Objectives The objective of this study was to characterize symptom prevalence, awareness of pelvic floor disorders (PFDs) in family/friends, and understanding of factors contributing to the development of PFDs in women aged 19 to 30 years. Methods This study is a cross-sectional study via online questionnaire survey of female students aged 19 to 30 years enrolled at the University of Alabama at Birmingham. Results of “adolescent women” aged 19 to 24 years were compared with “young women” aged 25 to 30 years. Results A total of 1092 questionnaires were completed with the mean age being 23.5 ± 3.1 years. The overall rate of urinary incontinence (UI) was 10.3% without a difference between adolescent and young women (P = 0.61). There were no differences in rates of urgency UI (P = 0.061), stress UI (P = 0.29), or pelvic organ prolapse (POP) symptoms (P = 0.56) between groups. There was no difference between groups in awareness of family members with UI, fecal incontinence (FI), or POP symptoms (P ≥ 0.24). However, logistic regression showed that the young women were more likely to have received education regarding UI (adjusted odds ratio [aOR], 2.6; 95% confidence interval [CI], 1.8–3.6), FI (aOR, 3.3; 95% CI, 2.2–4.8), POP (aOR, 2.9; 95% CI, 2.1–4.2), and have greater understanding regarding causes of UI (aOR, 2.9; 95% CI, 1.7–4.8), FI (aOR, 1.6; 95% CI, 1.1–2.3), and POP (aOR, 1.9; 95% CI, 1.3–2.9). Conclusions Women aged 25 to 30 years had more awareness and understanding of PFDs compared with adolescent women. These data may have implications for primary prevention strategies of PFDs.

Special Evidence-Based Considerations in Geriatric Gynecologic Care: Pelvic Floor Disorders

Pelvic floor disorders including urinary incontinence, fecal incontinence, and pelvic organ prolapse are conditions that are increasingly seen by gynecologists as women age. Nearly half of women over the age 80 have one or more pelvic floor symptoms and 1 in 5 of these women over the age 80 will have undergone at least one surgical procedure for prolapse or urinary incontinence. With a projected 9 % increase in the proportion of the US population over the age 65 by the year 2060, there will be a parallel increase in the number of older women seeking care for these conditions.