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INTRODUCTION AND HYPOTHESIS: To compare change in urgency urinary incontinence episodes (UUIEs) in women undergoing posterior tibial nerve stimulation (PTNS) plus mirabegron versus PTNS plus placebo for the treatment of refractory urgency urinary incontinence (UUI). The primary hypothesis was that combination therapy is superior to monotherapy. METHODS: A randomized controlled trial was performed in individuals identifying as female aged ≥ 18 years with UUI symptoms refractory to second-line treatment or who could not tolerate antimuscarinic medications. Both participants and providers were blinded to medication treatment allocation. Participants were randomized (1:1) to PTNS plus mirabegron or PTNS plus placebo. Participants completed a 3-day bladder diary prior to and after 12-week treatment. Validated symptom distress and impact questionnaires were obtained pre- and post-treatment. The primary outcome was change in mean number of UUIEs on a 3-day bladder diary pre- versus post-treatment between arms. Primary and secondary outcomes were analyzed via sample t tests. RESULTS: Fifty-four subjects were randomized, mean ± SD baseline age 56.2±15.6 years and body mass index 35.0±9.4 (kg/m2); no differences were noted in any clinical-demographic characteristics. There was a significant difference between arms in mean pre- to post-treatment UUIEs, 9.4±3.9, mirabegron versus 5.3±5.5, placebo (p=0.007). Significant differences were found pre- compared with post-treatment in urinary frequency, Overactive Bladder Questionnaire Short Form Symptom Bother and Symptom Health-Related Quality of Life scores. CONCLUSIONS: In subjects undergoing PTNS treatment for refractory UUI and OAB-wet symptoms, the addition of a ß-3 agonist produced significant improvement in both objective and subjective overactive bladder symptom outcomes compared with PTNS plus placebo.
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IMPORTANCE: Recurrent urinary tract infections (rUTIs) affect 2-10% of adult women and are associated with a significant effect on quality of life, daily activities, and mental health. OBJECTIVE: The aim of this study was to identify clinical characteristics associated with rUTIs among women seeking care for pelvic floor disorders at an academic tertiary urogynecology clinic. STUDY DESIGN: A retrospective case-control study of women presenting to an academic tertiary urogynecology clinic was conducted. Cases were women with rUTIs, defined as ≥2 UTIs in 6 months or ≥3 within 1 year. Controls were women with no culture documented UTIs. Cases were matched 2:1 to controls by age and body mass index. Demographic and clinical characteristics were compared between cases and controls, and bivariate characteristics with P values ≤0.2 were assessed for an independent association with rUTIs by multivariable logistic regression. RESULTS: A total of 285 cases with rUTIs were identified, and 150 matched controls had a mean (SD) age of 72 (11.8) years and a body mass index of 29.6 (6.7; calculated as weight in kilograms divided by height in meters squared). Multivariable analysis revealed that prolapse beyond the introitus (odds ratio [OR], 0.28; 95% confidence interval [CI], 0.13-0.60), parity (OR, 1.33; 95% CI, 1.08-1.64), Charlson Comorbidity Index (OR, 1.66; 95% CI, 1.37-2.03), and postvoid residual volume ≥100 mL (OR, 4.05; 95% CI, 2.01, 8.18) were associated with rUTIs. CONCLUSIONS: In this ambulatory urogynecologic population, prolapse through the introitus was negatively associated with rUTIs, whereas parity, increased medical comorbidities, and elevated postvoid residual volume were positively associated with rUTI. Future research should seek an increased understanding of these factors associated with rUTI to implement effective preventive strategies.
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Qualidade de Vida , Infecções Urinárias , Adulto , Humanos , Feminino , Idoso , Masculino , Estudos de Casos e Controles , Estudos Retrospectivos , Infecções Urinárias/epidemiologia , ProlapsoRESUMO
INTRODUCTION AND HYPOTHESIS: Despite growing interest in a mobile-app bowel diary to assess fecal incontinence (FI) symptoms, data are limited regarding the correlation between mobile-app diary and questionnaire-based outcomes. The primary aim is to determine whether percentage reduction in FI episodes (FIEs)/week recorded on a mobile-app diary correlates with changes in scores of validated FI-symptom measures from baseline to 12 weeks in women with FI undergoing percutaneous tibial nerve stimulation (PTNS) versus sham. METHODS: This is a planned secondary analysis of a multicenter randomized trial in which women with FI underwent PTNS or sham. FIEs were collected using a mobile-app diary at baseline and after 12 weekly sessions. FI-symptom-validated measures included St. Mark's, Accidental Bowel Leakage Evaluation, FI Severity Index (FISI), Colorectal Anal Distress Inventory, Colorectal Anal Impact Questionnaire, FI Quality of Life, Patient Global Impression of Improvement (PGI-I), and Patient Global Symptom Control (PGSC) rating. Spearman's correlation coefficient (ρ) was computed between %-reduction in FIEs/week and change in questionnaire scores from baseline to 12 weeks. Significance was set at 0.005 to account for multiple comparisons. RESULTS: Baseline characteristics of 163 women (109 PTNS, 54 sham) include mean age 63.4±11.6, 81% white, body mass index 29.4±6.6 kg/m2, 4% previous FI surgeries, 6.6±5.5 FIEs/week, and St. Mark's score 17.4±2.6. A significant correlation was demonstrated between %-reduction in FIEs/week and all questionnaires (p<0.005). A moderate-strength correlation (|ρ|>0.4) was observed for St. Mark's (ρ=0.48), FISI (ρ=0.46), PGI-I (ρ=0.51), and PGSC (ρ=-0.43). CONCLUSIONS: In women with FI randomized to PTNS versus sham, a moderate correlation was noted between FIEs measured via mobile-app diary and FI-symptom-validated questionnaire scores.
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Neoplasias Colorretais , Incontinência Fecal , Aplicativos Móveis , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Incontinência Fecal/terapia , Incontinência Fecal/complicações , Qualidade de Vida , Inquéritos e Questionários , Neoplasias Colorretais/complicações , Resultado do TratamentoRESUMO
OBJECTIVE: To identify vaginal morphology and position factors associated with prolapse recurrence following vaginal surgery. DESIGN: Secondary analysis of magnetic resonance images (MRI) of the Defining Mechanisms of Anterior Vaginal Wall Descent cross-sectional study. SETTING: Eight clinical sites in the US Pelvic Floor Disorders Network. POPULATION OR SAMPLE: Women who underwent vaginal mesh hysteropexy (hysteropexy) with sacrospinous fixation or vaginal hysterectomy with uterosacral ligament suspension (hysterectomy) for uterovaginal prolapse between April 2013 and February 2015. METHODS: The MRI (rest, strain) obtained 30-42 months after surgery, or earlier for participants with recurrence who desired reoperation before 30 months, were analysed. MRI-based prolapse recurrence was defined as prolapse beyond the hymen at strain on MRI. Vaginal segmentations (at rest) were used to create three-dimensional models placed in a morphometry algorithm to quantify and compare vaginal morphology (angulation, dimensions) and position. MAIN OUTCOME MEASURES: Vaginal angulation (upper, lower and upper-lower vaginal angles in the sagittal and coronal plane), dimensions (length, maximum transverse width, surface area, volume) and position (apex, mid-vagina) at rest. RESULTS: Of the 82 women analysed, 12/41 (29%) in the hysteropexy group and 22/41 (54%) in the hysterectomy group had prolapse recurrence. After hysteropexy, women with recurrence had a more laterally deviated upper vagina (p = 0.02) at rest than women with successful surgery. After hysterectomy, women with recurrence had a more inferiorly (lower) positioned vaginal apex (p = 0.01) and mid-vagina (p = 0.01) at rest than women with successful surgery. CONCLUSIONS: Vaginal angulation and position were associated with prolapse recurrence and suggestive of vaginal support mechanisms related to surgical technique and potential unaddressed anatomical defects. Future prospective studies in women before and after prolapse surgery may distinguish these two factors.
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Prolapso de Órgão Pélvico , Prolapso Uterino , Feminino , Humanos , Estudos Prospectivos , Estudos Transversais , Resultado do Tratamento , Procedimentos Cirúrgicos em Ginecologia/métodos , Vagina/diagnóstico por imagem , Vagina/cirurgia , Histerectomia Vaginal , Prolapso Uterino/cirurgia , Prolapso de Órgão Pélvico/cirurgiaRESUMO
IMPORTANCE: Understanding patients' perceptions of symptoms and outcomes of urogynecologic surgery is essential for providing high-quality care. OBJECTIVE: The aim of the study was to assess association of pain catastrophizing with pelvic floor symptom distress and impact, postoperative pain, and voiding trial in patients undergoing urogynecologic surgery. STUDY DESIGN: Individuals whose self-identified gender was female and were undergoing surgery March 2020-December 2021 were included. Participants completed the Pain Catastrophizing Scale (range 0-52), Pelvic Floor Distress Inventory, and Pelvic Floor Impact Questionnaire preoperatively. Pain catastrophizing was score ≥30 and describes the tendency to magnify the overall threat of pain. Voiding trial failure was inability to void ≥2/3 of instilled volume (≤300 mL). The association between pain catastrophizing and symptom distress and impact was assessed with linear regression. A P < 0.05 is significant. RESULTS: Three hundred twenty patients were included (mean age, 60 years, 87% White). Forty-six of 320 participants (14%) had a pain catastrophizing score ≥30. The pain catastrophizing group had higher body mass index (33 ± 12 vs 29 ± 5), more benzodiazepine use (26% vs 12%), greater symptom distress (154 ± 58 vs 108 ± 60), and greater urogenital (59 ± 29 vs 47 ± 28), colorectal (42 ± 24 vs 26 ± 23), and prolapse (54 ± 24 vs 36 ± 24) subscale scores, all P ≤ 0.02. The pain catastrophizing group had greater impact (153 ± 72 vs 72 ± 64, P < 0.01) and urogenital (60 ± 29 vs 34 ± 28), colorectal (36 ± 33 vs 16 ± 26), and prolapse (57 ± 32 vs 22 ± 27) subscale scores, P < 0.01. Associations remained controlling for confounders ( P < 0.01). The pain catastrophizing group had higher 10-point pain scores (8 vs 6, P < 0.01) and was more likely to report pain at 2 weeks (59% vs 20%, P < 0.01) and 3 months (25% vs 6%, P = 0.01). Voiding trial failure did not differ (26% vs 28%, P = 0.98). CONCLUSIONS: Pain catastrophizing is associated with greater pelvic floor symptom distress and impact and postoperative pain but not voiding trial failure.
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Neoplasias Colorretais , Diafragma da Pelve , Humanos , Feminino , Pessoa de Meia-Idade , Prolapso , Inquéritos e Questionários , Dor Pós-Operatória/diagnósticoRESUMO
BACKGROUND: Understanding how prenatal care influences planned postpartum contraception can help guide shared decision-making. This study looks to examine the association of the quality of prenatal care with planned postpartum contraception. METHODS: This is a retrospective cohort study conducted in a single tertiary, academic urban institution in the southwest United States. The institutional review board (IRB) for human research at Valleywise Health Medical Center approved this study. Using a validated measure of prenatal care, the Kessner index, prenatal care was classified as adequate, intermediate, or inadequate. The World Health Organization (WHO) protocol for contraceptive effectiveness was used to classify contraceptives as very effective, effective, and less effective. The planned contraceptive choice was determined at the time of hospital discharge after delivery by discharge summary. Chi-squared testing and logistic regression were used to measure associations between the adequacy of prenatal care and contraceptive planning. RESULTS: This study included 450 deliveries, 404 (90%) patients with adequate prenatal care, and 46 (10%) patients without adequate (intermediate or inadequate) prenatal care. There was not a statistically significant difference in planning for very effective or effective methods of contraception at hospital discharge between adequate (74%) and non-adequate (61%) prenatal care groups (p = 0.06). There was no association between the adequacy of prenatal care and the effectiveness of contraceptive planning after controlling for age and parity (aOR = 1.7, 95% CI 0.89-3.22). CONCLUSIONS: Many women chose very effective and effective methods of postpartum contraception; however, there was no statistically significant association between the quality of prenatal care and planned contraception at hospital discharge.
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Comportamento Contraceptivo , Serviços de Planejamento Familiar , Cuidado Pré-Natal , Tomada de Decisão Compartilhada , Qualidade da Assistência à Saúde , Estudos Retrospectivos , Estados Unidos , Humanos , Feminino , AdultoRESUMO
PURPOSE: We determined the utility of intraoperative data in predicting sacral neuromodulation outcomes in urgency urinary incontinence. MATERIALS AND METHODS: Intraoperative details of sacral neuromodulation stage 1 were recorded during the prospective, randomized, multicenter ROSETTA trial, including responsive electrodes, amplitudes, and response strengths (motor and sensory Likert scales). Stage 2 implant was performed for stage 1 success on 3-day diary with 24-month follow-up. An intraoperative amplitude response score for each electrode was calculated ranging from 0 (no response) to 99.5 (maximum response, 0.5 V). Predictors for stage 1 success and improvement at 24 months were identified by stepwise logistic regression confirmed with least absolute shrinkage and selection operator and stepwise linear regression. RESULTS: Intraoperative data from 161 women showed 139 (86%) had stage 1 success, which was not associated with number of electrodes generating an intraoperative motor and/or sensory response, average amplitude at responsive electrodes, or minimum amplitude-producing responses. However, relative to other electrodes, a best amplitude response score for bellows at electrode 3 was associated with stage 1 failure, a lower reduction in daily urgency urinary incontinence episodes during stage 1, and most strongly predicted stage 1 outcome in logistic modeling. At 24 months, those who had electrode 3 intraoperative sensory response had lower mean reduction in daily urgency urinary incontinence episodes than those who had no response. CONCLUSIONS: Specific parameters routinely assessed intraoperatively during stage 1 sacral neuromodulation for urgency urinary incontinence show limited utility in predicting both acute and long-term outcomes. However, lead position as it relates to the trajectory of the sacral nerve root appears to be important.
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Terapia por Estimulação Elétrica , Estimulação Elétrica Nervosa Transcutânea , Bexiga Urinária Hiperativa , Incontinência Urinária , Humanos , Feminino , Incontinência Urinária de Urgência/cirurgia , Estudos Prospectivos , Estimulação Elétrica Nervosa Transcutânea/métodos , Incontinência Urinária/terapia , Sacro/cirurgia , Plexo Lombossacral , Resultado do Tratamento , Terapia por Estimulação Elétrica/métodos , Bexiga Urinária Hiperativa/terapiaRESUMO
INTRODUCTION AND HYPOTHESIS: In women with advanced prolapse, differences in vaginal apex anchoring sites may impact surgical outcomes over time. The primary aim was to compare 5-year surgical outcomes of uterosacral ligament suspension (ULS) versus sacrospinous ligament fixation (SSLF) in women with advanced (stage III-IV) prolapse. METHODS: A secondary analysis was conducted in a subset of women with advanced prolapse from a multicenter randomized trial comparing ULS versus SSLF and its extended follow-up, using publicly accessible de-identified datasets. The primary outcome was time to failure, defined as any one of (1) apical descent > 1/3 into the vaginal canal or anterior/posterior compartment beyond the hymen, (2) bothersome vaginal bulge symptoms, or (3) re-treatment. Secondary outcomes include symptom severity measured by the Pelvic Organ Prolapse Distress Inventory (POPDI) and adverse events. RESULTS: Of 285 women, 90/147 (61.2%) in ULS and 88/138 (63.8%) in SSLF had advanced prolapse. Baseline characteristics did not differ between groups except for median-vaginal deliveries (3.0 [2.0, 5.0] versus 3.0 [2.0, 4.0], p < 0.01). The median time to failure was 1.7 years ULS versus 2.0 years SSLF (p = 0.42). Surgical failure increased over time in both groups with no intergroup difference; by year 5, the estimated failure rate was 67.7% ULS versus 71.5% SSLF (adjusted difference -3.8; 95%CI [-21.9, 14.2]). No differences were noted in individual failure components (p > 0.05). POPDI scores improved over 5 years without intergroup difference (ULS -68.0 ± 61.1 versus SSLF -69.9 ± 60.3, adjusted difference -0.1 [-20.0, 19.9]). No difference in adverse events were observed (p > 0.05). CONCLUSION: In women with advanced prolapse, surgical failure, symptom severity, and adverse events did not differ between ULS and SSLF over 5 years.
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Prolapso de Órgão Pélvico , Prolapso Uterino , Feminino , Humanos , Prolapso Uterino/cirurgia , Procedimentos Cirúrgicos em Ginecologia , Prolapso de Órgão Pélvico/cirurgia , Ligamentos/cirurgia , Ligamentos Articulares , Resultado do TratamentoRESUMO
INTRODUCTION AND HYPOTHESIS: In randomized trials both percutaneous tibial nerve stimulation (PTNS) and sham result in clinically significant improvements in accidental bowel leakage (ABL). We aimed to identify subgroups who may preferentially benefit from PTNS in women enrolled in a multicenter randomized trial. METHODS: This planned secondary analysis explored factors associated with success for PTNS vs sham using various definitions: treatment responder using three cutoff points for St. Mark's score (≥3-, ≥4-, and ≥5-point reduction); Patient Global Impression of Improvement (PGI-I) of ≥ much better; and ≥50% reduction in fecal incontinence episodes (FIEs). Backward logistic regression models were generated using elements with significance of p<0.2 for each definition and interaction terms assessed differential effects of PTNS vs sham. RESULTS: Of 166 women randomized, 160 provided data for at least one success definition. Overall, success rates were 65% (102 out of 158), 57% (90 out of 158), and 46% (73 out of 158) for ≥3-, ≥4-, and ≥5-point St Mark's reduction respectively; 43% (68 out of 157) for PGI-I; and 48% (70 out of 145) for ≥50% FIEs. Of those providing data for all definitions of success, 77% (109 out of 142) met one success criterion, 43% (61 out of 142) two, and 29% (41 out of 142) all three success criteria. No reliable or consistent factors were associated with improved outcomes with PTNS over sham regardless of definition. CONCLUSIONS: Despite exploring diverse success outcomes, no subgroups of women with ABL differentially responded to PTNS over sham. Success results varied widely across subjective and objective definitions. Further investigation of ABL treatment success definitions that consistently and accurately capture patient symptom burden and improvement are needed.
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Incontinência Fecal , Estimulação Elétrica Nervosa Transcutânea , Humanos , Feminino , Estimulação Elétrica Nervosa Transcutânea/métodos , Resultado do Tratamento , Incontinência Fecal/terapia , Nervo Tibial/fisiologia , Análise FatorialRESUMO
IMPORTANCE: Although transient voiding dysfunction is common after surgical correction of pelvic organ prolapse, it has not been well studied in women undergoing colpocleisis. OBJECTIVE: This study aimed to identify characteristics associated with discharge home with a urinary catheter in women undergoing colpocleisis. STUDY DESIGN: This is a secondary analysis of a multicenter prospective study examining the effect of pelvic support, symptoms, and satisfaction in women undergoing colpocleisis. Publicly accessible deidentified data sets of the index study were analyzed. Primary outcome was discharge with a urinary catheter postoperatively. Characteristics associated with discharge with catheter after colpocleisis were assessed via logistic regression. Covariates were selected based on statistical significance at 0.05 and clinical relevance on bivariate analysis. RESULTS: Of the 136 women (mean age, 77.8 ± 5.5 years) undergoing colpocleisis in the index study, 68 (50.0%) were discharged with catheter. Baseline characteristics did not differ, except that the catheter group had lower prior incontinence surgery (7.4% vs 22.1%, P = 0.02) and higher preoperative postvoid residual volume (PVR; 189.8 ± 187.6 vs 91.3 ± 124.2 mL, P < 0.01). Those discharged with catheter had greater estimated blood loss (128.7 ± 88.5 vs 95.3 ± 74.5 mL, P = 0.02), operative time (125.2 ± 56.3 vs 100.8 ± 45.4 minutes, P < 0.01), and concomitant levator myorrhaphy (82.4% vs 58.8%, P < 0.01). Multivariable analysis revealed preoperative PVR (adjusted odds ratio, 1.2; 95% confidence interval, 1.0-1.4 for every 50-mL increase in PVR) and levator myorrhaphy (adjusted odds ratio, 4.3; 95% confidence interval, 1.6-11.3) were associated with postoperative catheterization. CONCLUSIONS: In women undergoing colpocleisis, higher preoperative PVR and levator myorrhaphy were associated with discharge with catheter.
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Alta do Paciente , Prolapso de Órgão Pélvico , Feminino , Humanos , Gravidez , Idoso , Idoso de 80 Anos ou mais , Estudos Prospectivos , Colpotomia , Prolapso de Órgão Pélvico/cirurgia , CateterismoRESUMO
IMPORTANCE: Many health care providers place concomitant midurethral slings during pelvic organ prolapse repair, yet growing evidence supports staged midurethral sling placement. OBJECTIVES: The aim of this study was to compare urinary function after transvaginal uterovaginal prolapse repair with and without midurethral sling. STUDY DESIGN: Secondary analysis of the Study of Uterine Prolapse Procedures Randomized Trial (hysterectomy with uterosacral ligament suspension vs mesh hysteropexy). Our primary outcome was Urinary Distress Inventory score (UDI-6) through 5 years compared between women with and without a concomitant sling within prolapse repair arms. Sling effect was adjusted for select clinical variables and interaction terms (α = .05). RESULTS: The sling group included 90 women (43 hysteropexy, 47 hysterectomy), and the no-sling group included 93 women (48 hysteropexy, 45 hysterectomy). At baseline, the sling group reported more bothersome stress (66% vs 36%, P < 0.001) and urgency incontinence (69% vs 48%, P = 0.007). For hysteropexy, there were no significant long-term differences in UDI-6 scores or bothersome urine leakage between sling groups. For hysterectomy, women with sling had better UDI-6 scores across time points (adjusted mean difference, -5.1; 95% confidence interval [CI], -9.9 to -0.2); bothersome stress and urgency leakage were less common in the sling group (stress adjusted odds ratio, 0.1 [95% CI, 0.0-0.4]; urge adjusted odds ratio, 0.5 [95% CI, 0.2-1.0]). Treatment for stress incontinence over 5 years was similar in the sling (7.9%) versus no-sling (7.6%) groups. CONCLUSIONS: Five-year urinary outcomes of concomitant midurethral sling may vary by type of transvaginal prolapse surgery, with possible benefit of midurethral sling at the time of vaginal hysterectomy with apical suspension but not after mesh hysteropexy.
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Prolapso de Órgão Pélvico , Slings Suburetrais , Incontinência Urinária por Estresse , Prolapso Uterino , Feminino , Humanos , Masculino , Prolapso de Órgão Pélvico/complicações , Prolapso de Órgão Pélvico/cirurgia , Resultado do Tratamento , Incontinência Urinária por Estresse/complicações , Incontinência Urinária por Estresse/cirurgia , Prolapso Uterino/complicações , Prolapso Uterino/cirurgiaRESUMO
INTRODUCTION AND HYPOTHESIS: The objective was to compare body image and sexual activity and function changes up to 3 years after sacrospinous ligament fixation with graft hysteropexy or vaginal hysterectomy with uterosacral ligament suspension (hysterectomy). METHODS: This was a planned secondary analysis of a multi-center randomized trial of women undergoing prolapse repair with mesh hysteropexy versus hysterectomy. Women were masked to intervention. The modified Body Image Scale (BIS), sexual activity status, and Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) scores were reported at baseline and 1.5, 6, 12, 18, 24, and 36 months after surgery. We compared mean BIS and PISQ-IR scores, the proportion of women whose BIS scores met a distribution-based estimate of the minimally important difference (MID), and sexual activity status. Comparisons were analyzed with linear and logistic repeated measures models adjusted for site, intervention, visit, and intervention by visit interaction. RESULTS: Eighty-eight women underwent mesh hysteropexy; 87 underwent hysterectomy. Women were similar with regard to baseline characteristics, mean age 65.9 ± 7.3 years, and most had stage III or IV prolapse (81%). Baseline mean BIS scores were not significantly different, improved in both groups by 1.5 months, and were sustained through 36 months with no differences between groups (all p > 0.05). The estimated BIS MID was 3; and by 36 months, more women in the mesh hysteropexy group achieved the MID than in the hysterectomy group (62% vs 44%, p = 0.04). The makeup of the sexually active cohort changed throughout the study, making function comparisons difficult. CONCLUSIONS: Body image improves following prolapse surgery whether or not hysterectomy is performed or transvaginal mesh is used at the time of repair; sexual activity status changes over time following prolapse surgery.
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Prolapso de Órgão Pélvico , Prolapso Uterino , Idoso , Imagem Corporal , Feminino , Procedimentos Cirúrgicos em Ginecologia/métodos , Humanos , Histerectomia/métodos , Histerectomia Vaginal/métodos , Pessoa de Meia-Idade , Prolapso de Órgão Pélvico/cirurgia , Resultado do Tratamento , Prolapso Uterino/cirurgiaRESUMO
Fecal incontinence is a highly prevalent and debilitating condition that negatively impacts quality of life. The etiology is often multifactorial and treatment can be hindered by lack of understanding of its mechanisms and available treatment options. This article reviews the evidence-based update for the management of fecal incontinence.
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Incontinência Fecal , Canal Anal , Incontinência Fecal/diagnóstico , Incontinência Fecal/etiologia , Incontinência Fecal/terapia , Humanos , Qualidade de VidaRESUMO
BACKGROUND: Urinary incontinence is prevalent among women, and it has a substantial economic impact. Mixed urinary incontinence, with both stress and urgency urinary incontinence symptoms, has a greater adverse impact on quality of life and is more complex to treat than either stress or urgency urinary incontinence alone. Studies evaluating the cost-effectiveness of treating both the stress and urgency urinary incontinence components simultaneously are lacking. OBJECTIVE: Cost-effectiveness was assessed between perioperative behavioral and pelvic floor muscle therapies combined with midurethral sling surgery and midurethral sling surgery alone for the treatment of women with mixed urinary incontinence. The impact of baseline severe urgency urinary incontinence symptoms on cost-effectiveness was assessed. STUDY DESIGN: This prospective economic evaluation was performed concurrently with the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence randomized trial that was conducted from October 2013 to April 2016. Participants included 480 women with moderate-to-severe stress and urgency urinary incontinence symptoms and at least 1 stress urinary incontinence episode and 1 urgency urinary incontinence episode on a 3-day bladder diary. The primary within-trial analysis was from the healthcare sector and societal perspectives, with a 1-year time horizon. Costs were in 2019 US dollars. Effectiveness was measured in quality-adjusted life-years and reductions in urinary incontinence episodes per day. Incremental cost-effectiveness ratios of combined treatment vs midurethral sling surgery alone were calculated, and cost-effectiveness acceptability curves were generated. Analysis was performed for the overall study population and subgroup of women with Urogenital Distress Inventory irritative scores of ≥50th percentile. RESULTS: The costs for combined treatment were higher than the cost for midurethral sling surgery alone from both the healthcare sector perspective ($5100 [95% confidence interval, $5000-$5190] vs $4470 [95% confidence interval, $4330-$4620]; P<.01) and the societal perspective ($9260 [95% confidence interval, $8590-$9940] vs $8090 [95% confidence interval, $7630-$8560]; P<.01). There was no difference between combined treatment and midurethral sling surgery alone in quality-adjusted life-years (0.87 [95% confidence interval, 0.86-0.89] vs 0.87 [95% confidence interval, 0.86-0.89]; P=.90) or mean reduction in urinary incontinence episodes per day (-4.76 [95% confidence interval, -4.51 to 5.00] vs -4.50 [95% confidence interval, -4.25 to 4.75]; P=.13). When evaluating the overall study population, from both the healthcare sector and societal perspectives, midurethral sling surgery alone was superior to combined treatment. The probability that combined treatment is cost-effective compared with midurethral sling surgery alone is ≤28% from the healthcare sector and ≤19% from the societal perspectives for a willingness-to-pay value of ≤$150,000 per quality-adjusted life-years. For women with baseline Urogenital Distress Inventory irritative scores of ≥50th percentile, combined treatment was cost-effective compared with midurethral sling surgery alone from both the healthcare sector and societal perspectives. The probability that combined treatment is cost-effective compared with midurethral sling surgery alone for this subgroup is ≥90% from both the healthcare sector and societal perspectives, at a willingness-to-pay value of ≥$150,000 per quality-adjusted life-years. CONCLUSION: Overall, perioperative behavioral and pelvic floor muscle therapies combined with midurethral sling surgery was not cost-effective compared with midurethral sling surgery alone for the treatment of women with mixed urinary incontinence. However, combined treatment was of good value compared with midurethral sling surgery alone for women with baseline severe urgency urinary incontinence symptoms.
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Incontinência Urinária/terapia , Terapia Cognitivo-Comportamental/economia , Terapia Cognitivo-Comportamental/estatística & dados numéricos , Terapia Combinada , Análise Custo-Benefício , Feminino , Humanos , Pessoa de Meia-Idade , Modalidades de Fisioterapia/economia , Modalidades de Fisioterapia/estatística & dados numéricos , Estudos Prospectivos , Qualidade de Vida , Slings Suburetrais/economia , Slings Suburetrais/estatística & dados numéricos , Inquéritos e Questionários , Resultado do Tratamento , Incontinência Urinária/economiaRESUMO
OBJECTIVES: The objective of this study was to compare efficacy and adverse events between 100 U and 200 U of onabotulinumtoxinA for 6 months in women with nonneurogenic urgency incontinence. METHODS: This is a secondary analysis of 2 multicenter randomized controlled trials assessing efficacy of onabotulinumtoxinA in women with nonneurogenic urgency incontinence; one compared 100 U to anticholinergics and the other 200 U to sacral neuromodulation. Of 307 women who received onabotulinumtoxinA injections, 118 received 100 U, and 189 received 200 U. The primary outcome was mean adjusted change in daily urgency incontinence episodes from baseline over 6 months, measured on monthly bladder diaries. Secondary outcomes included perceived improvement, quality of life, and adverse events. The primary outcome was assessed via a multivariate linear mixed model. RESULTS: Women receiving 200 U had a lower mean reduction in urgency incontinence episodes by 6 months compared with 100 U (-3.65 vs -4.28 episodes per day; mean difference, 0.63 episodes per day [95% confidence interval (CI), 0.05-1.20]). Women receiving 200 U had lower perceptions of improvement (adjusted odds ratio, 0.32 [95% CI, 0.14-0.75]) and smaller improvement in severity score (adjusted mean difference, 12.0 [95% CI, 5.63-18.37]). Upon subanalysis of only women who were treated with prior anticholinergic medications, these differences between onabotulinumtoxinA doses were no longer statistically significant. There was no statistically significant difference in adverse events in women receiving 200 U (catheterization, 32% vs 23%; adjusted odds ratio, 1.4 [95% CI, 0.8-2.4]; urinary tract infection, 37% vs 27%; adjusted odds ratio, 1.5 [95% CI, 0.9-2.6]). CONCLUSIONS: A higher dose of onabotulinumtoxinA may not directly result in improved outcomes, but rather baseline disease severity may be a more important prediction of outcomes.
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Toxinas Botulínicas Tipo A/administração & dosagem , Incontinência Urinária de Urgência/tratamento farmacológico , Idoso , Toxinas Botulínicas Tipo A/efeitos adversos , Relação Dose-Resposta a Droga , Feminino , Seguimentos , Humanos , Injeções Intramusculares , Pessoa de Meia-Idade , Qualidade de Vida , Índice de Gravidade de Doença , Inquéritos e Questionários , Resultado do TratamentoRESUMO
AIM: To characterize symptom-specific distress and impact on quality of life (QOL) among women with urge, passive, and combined urge/passive fecal incontinence (FI) phenotypes. A secondary aim was to characterize FI symptom-specific distress and impact on women with a novel fourth phenotype, stress FI. METHODS: Women with at least monthly FI from 2003 to 2017 were included. Participants completed the Modified Manchester Health Questionnaire (MMHQ) including MHQ and Fecal Incontinence Severity Index (FISI). Anorectal manometry (ARM) and endoanal ultrasound (EAUS) testing was performed. Total MHQ and FISI scores were compared across FI subtypes controlling for pertinent baseline covariates. RESULTS: The cohort included 404 subjects, 220 meeting criteria for urge FI, 67 passive FI, and 117 combined urge/passive FI. On MHQ, women with combined urge/passive FI were most impacted (p < 0.01). FISI scores were significantly different from combined urge/passive FI having the greatest impact (38.1 ± 12.5) and urge FI (31.1 ± 11.3), p < 0.01 having the least. No differences were observed in ARM measurements or anal sphincter defects among the three groups (all p > 0.05). Twenty-nine subjects were identified with stress FI. There were no differences in overall MHQ or FISI scores or anal sphincter evaluation among the urge, passive, and stress FI groups (all p > 0.05). CONCLUSION: Women with combined urge/passive FI have higher symptom distress and impact on QOL than urge or passive FI alone. Further research is needed to determine the significance of stress FI as a subtype and response to treatment.
Assuntos
Incontinência Fecal/genética , Incontinência Fecal/terapia , Qualidade de Vida/psicologia , Estudos de Coortes , Feminino , Genótipo , Humanos , Pessoa de Meia-Idade , Fenótipo , Índice de Gravidade de DoençaRESUMO
INTRODUCTION AND HYPOTHESIS: The current study aims to assess the continence rate of a "second primary" midurethral sling (MUS) in women with recurrent/persistent stress urinary incontinence (SUI) after sling excision compared to a historical cohort who underwent a repeat MUS. METHODS: A retrospective cohort study of women who underwent excision of a primary MUS and placement of a "second primary" MUS from 2009 to 2016 compared to a historical cohort who underwent a repeat MUS from 2006 to 2009. The primary outcome was continence rate, defined as "not at all" or "somewhat" to Urogenital Distress Inventory (UDI-6) SUI subscale questions. Secondary outcomes included assessment of symptom severity (UDI-6), symptom-specific quality of life, Incontinence Impact Questionnaire (IIQ-7), Medical and Epidemiologic Aspects of Aging (MESA), and Patient Global Impression of Improvement (PGI-I). RESULTS: Survey responses were available for 23/64 (36%) in the "second primary" MUS group versus 88/135 (65%) in the historical cohort. Mean follow-up in months, second primary: 41.8 ± 26.1 versus repeat: 36.2 ± 14.1, p = 0.16 and age (years): 56.4 ± 10.7 versus 59.8 ± 10.8, p = 0.19. Continence rates were 48% in "second primary" versus 56% in the repeat group (p = 0.50). Both groups had significant improvement in questionnaire scores postoperatively with no intergroup differences. Multivariable analysis demonstrated that odds of success did not differ between groups (adjusted odds ratio: 0.73, 95% confidence interval: 0.27-1.99). CONCLUSIONS: In women with recurrent/persistent SUI, repeat and "second primary" MUS procedures demonstrate similar success outcomes and improvement in UI symptom distress and QOL. Continued research is needed for this increasingly important clinical question.
Assuntos
Slings Suburetrais , Incontinência Urinária por Estresse , Feminino , Humanos , Qualidade de Vida , Estudos Retrospectivos , Resultado do Tratamento , Incontinência Urinária por Estresse/cirurgiaRESUMO
INTRODUCTION AND HYPOTHESIS: To evaluate change in fecal incontinence symptom severity after 8 weeks of darifenacin therapy in patients with double incontinence-urgency urinary incontinence (UUI) and fecal incontinence. Important secondary outcomes included fecal incontinence symptom distress and impact on quality of life, fecal incontinence episodes, global impression of improvement and overactive bladder symptom distress and impact. METHODS: Prospective open-label cohort study of women presenting primarily with UUI, diagnosed with double incontinence and electing antimuscarinic therapy for UUI. Women ≥ 18 years with moderate or greater bothersome UUI and fecal incontinence of liquid/solid stool with St. Marks (Vaizey) score ≥ 12 were included. Subjects were treated with darifenacin 15 mg daily for 8 weeks. The primary outcome was change in fecal incontinence symptom severity using the St. Marks (Vaizey) score after 8 weeks. Sample size was based on the minimally important difference of the St. Marks, -5, and standard deviation, ± 8.5; 30 subjects provided 80% power and type I error of 0.05, including a 15% attrition rate. RESULTS: Thirty-two women were consented with mean baseline St. Marks (Vaizey) score of 18.0 ± 3.0. Mean age was 66.5 ± 10.3 years. Twenty-eight subjects (29/32, 87.5%) completed assessments. St. Marks (Vaizey) score significantly improved from 18.0 to 11.0 [mean difference - 7.0, 95% confidence interval (CI): -8.7, -5.3], and 19 subjects (19/32,67.9%) met the minimally important difference. Statistically significant improvements were also noted in fecal incontinence frequency, quality of life, and overactive bladder symptom bother and quality of life (all p < 0.01). CONCLUSIONS: Darifenacin can be considered a highly effective early intervention in women suffering from double incontinence. CLINICAL TRIAL REGISTRATION: Bladder Antimuscarinic Medication and Accidental Bowel Leakage (BAMA), https://clinicaltrials.gov/ct2/show/NCT03543566 , NCT03543566.