Urogynecology (Hagerstown, Md.)最新文献

Importance: Bladder onabotulinumtoxinA (BoNT-A) is a widely used third-line treatment for overactive bladder (OAB). The most common adverse event is postprocedure urinary tract infection (UTI), yet there are no specific guidelines for antibiotic prophylaxis for this procedure.

Objectives: Our primary aim was to establish noninferiority in the incidence of postprocedure UTI with single versus multiple-dose peri-procedural antibiotics. Our secondary aim was to describe the rates of adverse events in each group, including urinary retention requiring catheterization.

Study design: Adults undergoing office-based bladder BoNT-A were enrolled in this prospective, nonblinded, randomized noninferiority trial. Exclusion criteria included recurrent UTI or urinary retention. Patients were randomized 1:1 into 2 treatment arms: single dose versus 3 days of postprocedural antibiotics. Antibiotic choice was based on patient allergies, previous urine cultures, and drug interactions. Patients were assessed at 4 weeks postprocedure for any interval UTI treatment, urine culture results, retention, or adverse effects.

Results: We recruited 96 women with a mean age of 67 years. Patient characteristics and comorbidities were similar between groups (P>0.05). One patient in each arm (2%) developed UTI following BoNT-A (P=0.95), which did not meet the noninferiority definition due to the low incidence overall. One patient developed retention requiring catheterization, and 1 developed a vaginal yeast infection, both in the multidose arm.

Conclusions: This study suggests that a single dose of oral antibiotics is sufficient for the prevention of UTI with office injection of bladder BoNT-A for uncomplicated OAB, though further research is warranted to assess the applicability to a broader population.

Importance: While vaginal estrogen (VE) is a common treatment option for women with genitourinary syndrome of menopause, VE can be cost-prohibitive, causing medication nonadherence.

Objective: The objective of this study was to compare trends in VE pricing through retail pharmacies, Medicare Part D, the Mark Cuban Cost Plus Drug Company (CPD), and with the application of GoodRx coupons.

Study design: For this economic study, data from CPD and GoodRx were reviewed to obtain listed prices for various VE types and formulations, including conjugated estrogen cream (Premarin), estradiol 0.01% cream (Estrace), and estradiol 10 mcg tablets (Vagifem). GoodRx prices were obtained from 4 retail pharmacies within the most populous zip code from each U.S. state. Prices were adjusted to account for dosage and prescribed quantity to estimate an average cost per dosage unit ($/adu).

Results: Within zip codes, the mean $/adu of Premarin, Estrace, and Vagifem were $9.03, $3.45, and $9.86, with a standard deviation of 0.45 $/adu, 0.48 $/adu, and 0.56 $/adu. Comparing GoodRx to retail pricing, cost reductions were seen for all 3 medications, with an average saving of $7.45, $1.34, and $6.00 per dosing unit. Reduced prices for all medications were available through CPD versus GoodRx, with cost reduction of $0.35, $0.89, and $2.31 for each unit of Premarin, Estrace, and Vagifem.

Conclusions: While significant price variations for prescriptions were seen on a regional level within zip codes and between pharmacies, notable price savings were consistently seen with CPD and GoodRx, offering a solution to the financial strain that these prescriptions may impose.

Importance: Patient preferences regarding medical decision making are central to prolapse treatment discussions.

Objective: The objective of this study was to compare control preferences scale (CPS) and autonomy preference index (API) scores reported by underrepresented patients (UPs) to non-UPs after new patient consultations with urogynecology providers.

Study design: This was a planned secondary analysis of patients counseled regarding treatment of pelvic organ prolapse at 8 academic medical centers from July 2021 to December 2022. Participants completed the CPS (5-point scale, 1="I prefer to make the final decision" to 5="I prefer my doctor to make the decision"; scores 1-2 were considered preferring an "active" role). Participants also completed the API, which has 2 subscales (information seeking, 8 items; decision making, 6 items; scored 0-100) and 2 clinical vignettes (scored 0-20). Higher scores indicate stronger preferences for participation. P<0.05 is considered significant.

Results: Two hundred seven participants were included; 103 (49.8%) identified as UP and 122 (59%) pursued surgery. The mean CPS scores were not different between UPs versus non-UPs (2.0 ± 1.0 vs 2.1 ± 0.8, P=0.35), and most participants preferred an active role in decision making (145/194, 74.7%). The mean API scores were different between groups (UP, 149.2 ± 27.7 vs non-UP, 159.4 ± 22.5, P=0.008). When adjusting for education, income, insurance, and prior prolapse surgery, self-identification with non-Hispanic Black race was associated with lower API scores compared with non-UPs (adjusted difference of 12.4, SE±5.1, P=0.023).

Conclusions: Autonomy preferences may vary, and most participants prefer an active role in prolapse treatment decision making.

Importance: Urinary incontinence (UI) can negatively affect sexual function in women. Although many women with UI seek complementary strategies such as pelvic floor yoga techniques to improve sexual functioning, evidence of their efficacy is limited.

Objective: The objective of this study was to evaluate the effects of a pelvic floor yoga program versus a general physical conditioning program on multidimensional sexual function in women with UI.

Study design: Ambulatory women aged 45 and older with daily UI were enrolled in a multicenter randomized trial in 2019-2022. Participants were randomized to a 12-week program of group instruction and self-practice of Hatha yoga techniques tailored to pelvic floor function (pelvic yoga) or a time-equivalent program of general skeletal muscle exercises (physical conditioning). Intervention effects on sexual function, a prespecified secondary trial outcome, were examined using linear mixed models of change in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) scores over 6 and 12 weeks of intervention instruction.

Results: Among 240 participants (121 pelvic yoga, 119 physical conditioning; ages 45-90 years), UI frequency averaged 3.4±2.2 episodes/day, and 129 (54.7%) participants were sexually active at baseline. Compared with physical conditioning, pelvic yoga did not result in significantly greater improvements in any PISQ-IR domain over 6 and 12 weeks. Within-group analyses showed that sexually active participants in the yoga group had a 3.7 (95% CI: 1.4-6.1) point improvement in condition-specific impact on sexual activity.

Conclusions: Among midlife and older women with daily UI, a 12-week pelvic yoga intervention did not result in meaningfully greater improvements in sexual function compared with nonspecific physical conditioning exercise.

Importance: Only a fraction of women with overactive bladder (OAB) receive effective treatment for this condition; inequities in access to OAB care must be understood.

Objective: The objective of this study was to explore features associated with intradetrusor chemodenervation treatment for OAB among female Medicare beneficiaries from different racial and ethnic groups.

Study design: This was a retrospective cohort study of females ≥65 years old from the Center for Medicare & Medicaid Services' 5% Limited Data Set with a diagnosis of OAB between 2012 and 2020. The cumulative incidence of beneficiaries who received intradetrusor chemodenervation within 5 years following OAB diagnosis was compared between race and ethnicity groups. Cox regression analysis was performed to determine predictors for the likelihood of intradetrusor chemodenervation treatment and to adjust for potential confounders.

Results: In total, 232,366 females with a new OAB diagnosis were identified. The cumulative incidence of intradetrusor chemodenervation treatment within 5 years of OAB diagnosis was low at 1.4%, with lower rates among Asian (0.6%), Black (0.7%), Hispanic (0.7%), and Other groups (0.9%) (P < 0.001). After adjustments, non-White race and Hispanic ethnicity (Asian: adjusted hazard ratio [aHR] 0.51, 95% CI: 0.33-0.80; Black: aHR 0.56, 95% CI: 0.45-0.69; Hispanic: aHR 0.62, 95% CI: 0.40-0.96; Other: aHR 0.58, 95% CI: 0.37-0.91) were associated with a lower relative hazard of receiving intradetrusor chemodenervation.

Conclusions: Overall utilization of intradetrusor chemodenervation was low in this national cohort. Women from non-White racial and ethnic groups had lower rates of utilization compared with White women. Further research should evaluate barriers patients face in accessing this effective OAB treatment and explore potential interventions that facilitate access to care.

Importance: Idiopathic normal pressure hydrocephalus (iNPH) is characterized by dementia, gait disturbance, and urinary incontinence (UI). While gait and cognitive impairments trigger a focused workup, UI is often excused by female patients and doctors as normal aging in women.

Objectives: The objectives of this study were to evaluate sex differences in time from UI documentation to iNPH diagnosis and describe differences in postoperative UI outcomes following ventriculoperitoneal shunt placement.

Study design: This was a single-center, retrospective study of patients treated for iNPH who presented with the complete triad of symptoms. The primary outcome was the time from UI documentation to iNPH diagnosis compared between sexes with a 2-tailed Student t test. Sex differences in diagnostic timing and 3-month postoperative outcomes (gait, cognition, and UI) were analyzed with χ 2 tests.

Results: Eighty-two patients (38 male and 44 female) were included in the analysis. Females experienced a longer time to diagnosis than males (40.3 vs 16.8 mo; P =0.001). Following surgery, no significant sex differences were observed in gait ( P =0.32), cognitive ( P =0.17), or UI improvement ( P =0.11), but females had lower rates of complete UI resolution (13.6% vs 36.8%; P =0.020). In females, but not males, 3-month UI improvement (12.5 vs 46.8 mo; P =0.02) and resolution (1.7 vs 35.4 mo; P =0.002) correlated with shorter time to diagnosis.

Conclusions: Females with UI face a longer time to iNPH diagnosis and lower rates of complete symptom resolution. Increased awareness of iNPH in this population is essential for timely screening and improved outcomes.

Importance: Urinary tract infections in adult women are commonlytreated by gynecologists and urologists.

Objective: The objective of this study was to estimate the frequency of and factors associated with mortality among women hospitalized with a primary diagnosis of a urinary tract infection (UTI).

Study design: This was a retrospective cohort study using the National Inpatient Sample of adult women hospitalized with a UTI between 2016 and 2020. Patients' demographic, hospital-level data, comorbidities, and associated diagnoses were identified using International Classification of Diseases, Tenth Revision, (ICD-10) codes. The primary outcome was death during hospitalization. Independent associations with death were analyzed using multivariable logistic regression of variables that occurred in 2% or more of hospitalizations (irrespective of outcome).

Results: A total of 330,905 hospitalizations with a primary diagnosis of UTI were identified, including 1,588 deaths (0.48%). Death was most strongly correlated with increasing age: above 85 years (adjusted odds ratio [aOR], 8.37; 95% CI, 5.69-12.30), age 76-85 years (aOR, 5.63; 95% CI, 3.83-8.27), age 66-75 years (aOR, 4.45; 95% CI, 3.01-6.57), age 51-65 years (aOR, 3.17; 95% CI, 2.12-4.73) compared with those 18-50 years. The comorbidities and diagnoses most associated with death included metastatic cancer (aOR, 4.25; 95% CI, 3.50-5.16), pneumonia (aOR, 3.68; 95% CI, 3.17-4.28), and weight loss (aOR, 2.98; 95% CI, 2.65-3.36). Bacteremia (aOR, 0.65; 95% CI, 0.45-0.95), complicated hypertension (aOR, 0.61; 95% CI, 0.52-0.72), depression (aOR, 0.75; 95% CI, 0.65-0.87), and nutritional anemia (aOR, 0.76; 95% CI, 0.60-0.96) were most associated with a decreased probability of death.

Conclusion: Death during hospitalization for a diagnosis of UTI was rare, even in critically ill and extremely elderly patients.

Importance: There is a need to understand phenotype-specific therapies for interstitial cystitis/bladder pain syndrome (IC/BPS) at the clinical trial level to move beyond trial-and-error treatment approaches.

Objective: The objective of this study was to characterize IC/BPS clinical trials that incorporate patient phenotype into the eligibility criteria in accordance with the American Urological Association (AUA) guidelines.

Study design: Registered IC/BPS clinical trials were identified from ClinicalTrials.gov. Trials were included if they enrolled patients with IC/BPS and addressed pain-related outcomes. Trials were assessed for phenotype recognition and categorized by intervention type, funding source, and registration date relative to the AUA's 2015 IC/BPS guidelines for initial phenotype recognition.

Results: Out of 170 trials, 37 (21.8%) included phenotype stratification. The majority focused on bladder-centric presentations. Men were underrepresented in IC/BPS clinical trials. Phenotypic stratification was more frequently reported in industry-funded trials compared with those without industry support (40.5% vs 16.5%, P =0.0031). Trials registered after the 2015 AUA guideline update showed greater phenotype inclusion, though this was not statistically significant (26.6% vs 15.8%). Therapeutic trials comprised the majority of trials. Stratification appeared more often in physical therapy and psychosocial trials at 40% and in drug studies at 34.3%. Intravesical instillation and injection trials showed lower rates at 19.6% and 13.0%, respectively.

Conclusions: Failure to incorporate IC/BPS phenotypes into trial design limits the ability to evaluate treatments within the context of real-world symptom variability. Bridging this methodological gap is essential to ensure that clinical research supports the development of more targeted and effective therapies.

Importance: Comprehensive understanding of anatomic landmarks is essential for safe and successful apical suspension during vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) procedures. However, detailed descriptions of these landmarks remain scarce in the current literature.

Objective: We aimed to delineate the anatomic relationships of key landmarks relevant to apical suspension procedures performed through vNOTES.

Study design: Ten embalmed female cadavers were dissected. A 9.5 cm Alexis retractor from the commercially manufactured vNOTES port was used. Distances were measured from the inner ring of the retractor to the following anatomic structures: the ischial spine (sagittal and transverse planes), S1 root, urethra, trigone, pubic crest, and iliac vessels.

Results: The mean distance from the retractor's inner ring to the ischial spine was 1.0 cm (range: 0.9-1.3, SD: 0.1) sagittally and 3.6 cm (range: 3.0-4.9, SD: 0.6) transversely. The S1 foramen was located 6.4 cm (range: 5.0-8.0, SD: 1.0) from the ring's midpoint. Sagittal measurements revealed a mean distance of 2.6 cm (range: 1.7-3.5, SD: 1.0) from the proximal urethra and 1.9 cm (range: 1.4-3.5, SD: 0.7) from the trigone. The external iliac vessels were 3.2 cm (range: 2.1-4.1, SD: 0.7) from the ring's edge, while the pubic crest was 2.7 cm (range: 1.6-3.3, SD: 0.5) away.

Conclusions: The spatial relationships described in this study provide crucial reference points for surgeons performing apical suspension during vNOTES. Knowledge of these relationships can enhance safety and provide a roadmap for future innovation and the advancement of complex gynecologic interventions.

Importance: Despite the popularity of urethral bulking with polyacrylamide hydrogel (PAHG) for stress urinary incontinence (SUI)/intrinsic sphincter deficiency (ISD), no studies have assessed optimal anesthetic protocols.

Objectives: To compare pain scores between 2 anesthetic protocols in women undergoing in-office PAHG injection: (1) combined anesthetic [external lidocaine-plus-prilocaine (EMLA) cream, intraurethral lidocaine gel, and lidocaine periurethral block] or (2) topical-only (external EMLA cream and intraurethral lidocaine gel).

Study design: This single-blinded trial randomized women to 1 of 2 anesthetic protocols. The primary outcome was pain reported via a 10-point visual analog scale (VAS). Secondary outcomes included International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI) and Patient Global Impression of Improvement (PGI-I) scores. A safety endpoint of 3 subjects in the topical-only arm requiring unplanned periurethral block to complete the PAHG procedure, and an a priori sample size of 52 subjects was set.

Results: Recruitment stopped at 23 subjects (N=11 combined anesthetic vs. N=12 topical-only) upon meeting the safety endpoint. Mean procedural VAS pain scores were lower with concomitant periurethral block (4.5±2.7 combined anesthetic vs. 7.4±2.3 topical-only; P<0.01). For 3 subjects in the topical-only arm requiring additional anesthesia, VAS pain scores were reduced following periurethral block (10.0±0.0 preblock to 4.0±2.6 postblock; P=0.04). There was no difference between arms in procedure duration, reinjection, or questionnaire scores. Subjects in the combined anesthetic arm were less likely to require post-procedure straight catheterization (0% vs. 33% topical-only; P=0.04).

Conclusions: Use of a periurethral block with topical anesthetics reduced pain scores and improved postprocedure voiding. These findings support using a combined anesthetic protocol for women undergoing in-office PAHG injection.