Nonestrogen Therapies for Treatment of Genitourinary Syndrome of Menopause: A Systematic Review.

OBJECTIVE: To systematically review the literature and provide clinical practice guidelines regarding various nonestrogen therapies for treatment of genitourinary syndrome of menopause (GSM). DATA SOURCES: MEDLINE, EMBASE, ClinicalTrials.gov , and Cochrane databases were searched from inception to July 2021. We included comparative and noncomparative studies. Interventions and comparators were limited to seven products that are commercially available and currently in use (vaginal dehydroepiandrosterone [DHEA], ospemifene, laser or energy-based therapies, polycarbophil-based vaginal moisturizer, Tibolone, vaginal hyaluronic acid, testosterone). Topical estrogen, placebo, other nonestrogen products, as well as no treatment were considered as comparators. METHODS OF STUDY SELECTION: We double-screened 9,131 abstracts and identified 136 studies that met our criteria. Studies were assessed for quality and strength of evidence by the systematic review group. TABULATION, INTEGRATION, AND RESULTS: Information regarding the participants, details on the intervention and comparator and outcomes were extracted from the eligible studies. Alternative therapies were similar or superior to estrogen or placebo with minimal increase in adverse events. Dose response was noted with vaginal DHEA and testosterone. Vaginal DHEA, ospemifene, erbium and fractional carbon dioxide (CO 2 ) laser, polycarbophil-based vaginal moisturizer, tibolone, hyaluronic acid, and testosterone all improved subjective and objective signs of atrophy. Vaginal DHEA, ospemifene, tibolone, fractional CO 2 laser, polycarbophil-based vaginal moisturizer, and testosterone improved sexual function. CONCLUSION: Most nonestrogen therapies are effective treatments for the various symptoms of GSM. There are insufficient data to compare nonestrogen options to each other.

De novo stress urinary incontinence after pelvic organ prolapse surgery in women without occult incontinence.

INTRODUCTION AND HYPOTHESIS: There is a paucity of data evaluating the risk of de novo stress urinary incontinence (SUI) after surgery for pelvic organ prolapse (POP) in women with no preoperative occult SUI. We hypothesized that apical suspension procedures would have higher rates of de novo SUI. METHODS: This was a retrospective database review of women who had surgery for POP from 2003 to 2013 and developed de novo SUI at ≥6 months postoperatively. Preoperatively, all patients had a negative stress test and no evidence of occult SUI on prolapse reduction urodynamics. The primary objective was to establish the incidence of de novo SUI in women with no objective evidence of preoperative occult SUI after POP surgeries at ≥6 months. RESULTS: A total number of 274 patients underwent POP surgery. The overall incidence of de novo SUI was 9.9 % [95 % confidence interval (CI) 0.07-0.14]. However, the incidence of de novo SUI in those with no baseline complaint of SUI was 4.4 % (95 % CI 0.03-0.1). There was no difference in de novo SUI rates between apical [9.7 % (n = 57)] and nonapical [10.5 %, (n = 217] procedures (p = 0.8482). Multivariate logistic regression identified sacrocolpopexy [adjusted odds ratio (OR) 4.54, 95 % CI 1.2-14.7] and those with a baseline complaint of SUI (adjusted OR 5.1; 95 % CI 2.2-12) as risk factors for de novo SUI. CONCLUSIONS: The incidence of de novo SUI after surgery for POP without occult SUI was 9.9 %. We recommend counseling patients about the risk of de novo SUI and offering a staged procedure.

Intraoperative Cystoscopic Evaluation of Ureteral Patency: A Randomized Controlled Trial.

OBJECTIVE: To compare different modalities to aid in the evaluation of intraoperative ureteral patency on cystoscopy in the postindigo carmine era. METHODS: In a randomized controlled trial, participants undergoing pelvic surgery were randomized into one of four groups: saline distention (control), 10% dextrose distention, oral phenazopyridine, or intravenous sodium fluorescein. Our primary outcome was visibility of the ureteral jets. Secondary outcomes included surgeon satisfaction; adverse reactions including allergies, urinary tract infections, urinary retention, cystoscopy times, and ureteral obstruction; and delayed diagnosis. Participants were followed for 6 weeks. A sample size of 176 participants was planned to demonstrate a 30% difference in the visibility scale. All analyses were performed in an intention-to-treat fashion. RESULTS: From February 25, 2015, through August 2015, 176 participants were enrolled; 174 completed the trial, and two did not undergo intervention. Forty-four participants were included in the phenazopyridine, dextrose, saline, and sodium fluorescein groups. Sodium fluorescein and 10% dextrose resulted in significantly improved visibility and satisfaction when compared with the control group (P<.001 and P=.004, respectively). Dextrose provided the highest satisfaction and phenazopyridine provided lowest, but visibility was not statistically different between the two groups (P=.101). Three ureteral obstructions were identified intraoperatively and none in the postoperative period. Mean total cystoscopy time varied between 4.0 and 4.8 minutes and postoperative urinary retention rate was 50% across all groups. Overall urinary tract infection rate was 24.1%, which was similar between interventions. There were no related adverse events. CONCLUSION: Compared with the control, 10% dextrose and sodium fluorescein resulted in improved visibility and provided significantly more satisfaction in the evaluation for ureteral patency with no considerable increase in operative time or morbidity. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT02476448.

Health Care Disparities Among English-Speaking and Spanish-Speaking Women With Pelvic Organ Prolapse at Public and Private Hospitals: What Are the Barriers?

OBJECTIVES: The objective of this study was to compare perceptions and barriers between Spanish-speaking and English-speaking women in public and private hospitals being treated for pelvic organ prolapse (POP). METHODS: Eight focus groups, 4 in English and 4 in Spanish, were conducted at 3 institutions with care in female pelvic medicine and reconstructive surgery. Standardized questions were asked regarding patients' emotions to when they initially noticed the POP, if they sought family support, and their response to the diagnosis and treatment. Transcripts were analyzed using grounded theory qualitative methods. RESULTS: Thirty-three women were Spanish-speaking and 25 were English-speaking. Spanish speakers were younger (P = 0.0469) and less likely to have a high school diploma (P < 0.0001) than English speakers. Spanish-speaking women had more concerns that the bulge or treatments could lead to cancer, were more resistant to treatment options, and were less likely to be offered surgery. Women in the private hospital desired more information, were less embarrassed, and were more likely to be offered surgery as first-line treatment. The concept emerged that patient care for POP varied based on socioeconomic status and language and suggested the presence of disparities in care for underserved women with POP. CONCLUSIONS: The discrepancies in care for Spanish-speaking women and women being treated at public hospitals suggest that there are disparities in care for POP treatment for underserved women. These differences may be secondary to profit-driven pressures from private hospitals or language barriers, low socioeconomic status, low health literacy, and barriers to health care.

Apical sling: an approach to posthysterectomy vault prolapse.

INTRODUCTION AND HYPOTHESIS: This video demonstrates a transvaginal technique for vaginal vault suspension using an apical sling suspended from the sacrospinous ligaments. METHODS: This was a retrospective review of apical sling procedures performed from July 2013 to November 2014. The technique is started by marking the vaginal apex. A posterior dissection is performed and the sacrospinous ligaments are identified after dissection into the pararectal space. A 10-cm piece of monofilament, inelastic polypropylene tape is attached to the underside of the vaginal apex. Polypropylene sutures are placed into the sacrospinous ligament and threaded though the lateral edges of the apical sling and tied down, restoring apical support. Finally, the vaginal epithelium is closed. RESULTS: A total of 67 women underwent an apical sling procedure with 70 % (47/67) completing 6 months follow-up. The subjective cure rate ("cured" or "greatly improved") was 78.7 % and the objective cure rate (anatomical success, defined as apical prolapse stage ≤1) was 100 % (47 patients). CONCLUSIONS: Our apical sling sacrospinous ligament fixation approach is a unique, minimal mesh approach using a tape commonly used for midurethral slings to suspend the vaginal apex. We achieved high anatomical success and patient satisfaction.

Management of apical pelvic organ prolapse.

UNLABELLED: Pelvic organ prolapse is a prevalent condition, with up to 12 % of women requiring surgery in their lifetime. This manuscript reviews the treatment options for apical prolapse, specifically. Both conservative and surgical management options are acceptable and should be based on patient preferences. Pessaries are the most commonly used conservative management options. Guided pelvic floor muscle training is more beneficial than self-taught Kegel exercises, though may not be effective for high stage or apical prolapse. Surgical treatment options include abdominal and vaginal approaches, the latter of which can be performed open, laparoscopically, and robotically. A systematic review has demonstrated that sacrocolpopexy has better long-term success for treatment of apical prolapse than vaginal techniques, but vaginal surgery can be considered an acceptable alternative. Recent data has demonstrated equal efficacy between uterosacral ligament suspension and sacrospinous ligament suspension at 1 year. To date, two randomized controlled trials have demonstrated equal efficacy between robotic and laparoscopic sacrocolpopexy. Though abdominal approaches may have increased long-term durability, when counseling their patients, surgeons should consider longer operating times and increased pain and cost with these procedures compared to vaginal surgery. KEY POINTS: • Pelvic floor physical therapy (PFPT) with a physical therapist is the best approach to conservative management of apical prolapse [10]. • Pessaries should be managed with regular follow-up care to minimize complications [14•]. • Minimally invasive sacrocolpopexy appears as effective as the gold standard abdominal sacrocolpopexy (ASC) [42•]. • Robotic assisted sacrocolpopexy (RASC) and laparoscopic assisted sacrocolpopexy (LASC) are equally effective and should be utilized by pelvic floor surgeons based on their skill level and expertise in laparoscopy [44, 45•]. • Uterosacral ligament suspension (USLS) and sacrospinous ligament suspension (SSLS) are considered equally effective procedures and can be combined with a vaginal hysterectomy. • Obliterative procedures are effective but are considered definitive surgery [24••]. • The use of transvaginal mesh has been shown in some studies to be superior to native tissue repairs with regard to anatomic outcomes, but complication rates are higher. Transvaginal mesh should be reserved for surgeons with adequate training so that complications are minimized.

Measuring the quality of care provided to women with pelvic organ prolapse.

OBJECTIVE: Health care providers are increasingly being evaluated by the quality of care they provide. Our aim was to assess the feasibility of recently developed quality indicators (QIs) for pelvic organ prolapse (POP) and identify possible deficits in care. STUDY DESIGN: A panel ranked 14 QIs based on the RAND appropriateness method assessing screening and diagnosis, pessary management, and surgery for POP. Retrospective chart abstraction was performed after identifying patients with a diagnosis of POP evaluated within a hospital-based multispecialty group using International Classification of Diseases, ninth edition, diagnosis codes. RESULTS: Of 283 patients identified, 98% of those with a new complaint of vaginal bulge had a pelvic examination. The POP was described but not staged in 6% and not documented at all in 25.1%. Among those managed with pessaries, 98% had vaginal examinations at least every 6 months. Forty-nine percent of the patients who had surgery had complete preoperative POP staging. Only 20% of women undergoing apical surgery had documentation of counseling regarding different surgical options, and of the women who underwent a hysterectomy for POP, only 48% had a concomitant vault suspension. Although 71% had documentation about the risk of postoperative stress incontinence, only 14.5% had documented counseling regarding risks of mesh. Only 37% of patients implanted with mesh for POP had documented follow-up at 1 year. An intraoperative cystoscopy was performed in 86% undergoing cystocele repair or apical surgery. CONCLUSION: The quality of care for women with POP can be feasibly measured with QIs. Processes of care were deficient in many areas, and our findings can serve as a basis for quality improvement interventions.

Role of apical support defect: correction in women undergoing vaginal prolapse surgery.

PURPOSE OF REVIEW: The aim was to review most recent literature and provide updates in clinical management and surgical treatment of apical pelvic organ prolapse. RECENT FINDINGS: In patients who decline surgical intervention, formal referral to pelvic floor muscle training is beneficial over self-directed Kegel exercises. Systematic reviews revealed that sacrocolpopexy has better long-term outcomes than vaginal approaches. Uterosacral ligament suspension and sacrospinous ligament suspension have equal efficacy at 1 year. These procedures should be considered as acceptable alternatives to sacrocolpopexy. Two randomized controlled trials have demonstrated equal efficacy between robotic and laparoscopic sacrocolpopexy. SUMMARY: Minimally invasive sacrocolpopexy should be considered the gold standard for apical prolapse, but these techniques are associated with longer operating times and higher complication rates and longer convalescence than nonmesh vaginal surgery. Surgeons must individualize surgical technique for each patient and should consider a vaginal approach in patients who do not desire laparotomy and are not candidates for minimally invasive surgery.

Readability of common health-related quality-of-life instruments in female pelvic medicine.

OBJECTIVES: The average American adult reads below the eighth-grade level. To determine whether self-reported health-related quality-of-life questionnaires used for pelvic floor disorders are appropriate for American women, we measured reading levels of questionnaires for urinary incontinence (UI), pelvic organ prolapse (POP), and fecal incontinence (FI). METHODS: An online literature search identified questionnaires addressing UI, POP, and FI. Readability was assessed using Flesch-Kincaid reading level and ease formulas. Flesch-Kincaid grade level indicates the average grade one is expected to completely and lucidly comprehend the written text. Flesch-Kincaid reading ease score, from 0 to 100, indicates how easy the written text can be read. RESULTS: Questionnaires were categorized by UI, POP, FI, and combined pelvic floor symptoms. The median Flesch-Kincaid reading level was 7.2, 10.1, 7.6, and 9.7, for UI, POP, FI, and combined pelvic floor symptoms, respectively. Reading levels varied greatly between questionnaires, with only 54% of questionnaires written below the eighth-grade level. CONCLUSIONS: We identified significant variation in reading levels among the questionnaires and found the 2 most commonly used questionnaires per survey in 2008 at Society of Urodynamics and Female Pelvic Medicine and Urogenital Reconstruction were above the recommended eighth-grade reading level. As specialty societies focus on standardizing questionnaires for research, reading levels should be considered so they are generalizable to larger populations of women with pelvic floor disorders.

Communication between physicians and Spanish-speaking Latin American women with pelvic floor disorders: a cycle of misunderstanding?

OBJECTIVE: This study aimed to assess the effect of the initial visit with a specialist on disease understanding among Spanish-speaking women with pelvic floor disorders. METHODS: Spanish-speaking women with referrals suggestive of urinary incontinence (UI) and/or pelvic organ prolapse (POP) were recruited from public urogynecology clinics. Patients participated in a health literacy assessment and interview before and after their physician encounter. All interviews were analyzed using Grounded Theory qualitative methods. RESULTS: Twenty-seven women with POP (n = 6), UI (n = 11), and POP/UI (n = 10) were enrolled in this study. The mean age was 55.5 years, and most women had marginal levels of health literacy. From our qualitative analysis, 3 concepts emerged. First, was that patients had poor understanding of their diagnosis before and after the encounter regardless of how extensive the physician's explanation or level of Spanish-proficiency. Second, patients were overwhelmed with the amount of information given to them. Lastly, patients ultimately put their trust in the physician, relying on them for treatment recommendations. CONCLUSIONS: Our findings emphasize the difficulty Spanish-speaking women with low health literacy have in understanding information regarding pelvic floor disorders. In this specific population, the physician has a major role in influencing patients' treatment decisions and helping them overcome fears they may have about their condition.