Real-World Evidence From a Digital Health Treatment Program for Female Urinary Incontinence: Observational Study of Outcomes Following User-Centered Product Design.

BACKGROUND: Urinary incontinence (UI) affects millions of women with substantial health and quality-of-life impacts. Supervised pelvic floor muscle training (PFMT) is the recommended first-line treatment. However, multiple individual and institutional barriers impede women's access to skilled care. Evidence suggests that digital health solutions are acceptable and may be effective in delivering first-line incontinence treatment, although these technologies have not yet been leveraged at scale. OBJECTIVE: The primary objective is to describe the effectiveness and safety of a prescribed digital health treatment program to guide PFMT for UI treatment among real-world users. The secondary objectives are to evaluate patient engagement following an updated user platform and identify the factors predictive of success. METHODS: This retrospective cohort study of women who initiated device use between January 1, 2022, and June 30, 2023, included users aged ≥18 years old with a diagnosis of stress, urgency, or mixed incontinence or a score of >33.3 points on the Urogenital Distress Inventory Short Form (UDI-6). Users are prescribed a 2.5-minute, twice-daily, training program guided by an intravaginal, motion-based device that pairs with a smartphone app. Data collected by the device or app include patient-reported demographics and outcomes, adherence to the twice-daily regimen, and pelvic floor muscle performance parameters, including angle change and hold time. Symptom improvement was assessed by the UDI-6 score change from baseline to the most recent score using paired 2-tailed t tests. Factors associated with meeting the UDI-6 minimum clinically important difference were evaluated by regression analysis. RESULTS: Of 1419 users, 947 met inclusion criteria and provided data for analysis. The mean baseline UDI-6 score was 46.8 (SD 19.3), and the mean UDI-6 score change was 11.3 (SD 19.9; P<.001). Improvement was reported by 74% (697/947) and was similar across age, BMI, and incontinence subtype. Mean adherence was 89% (mean 12.5, SD 2.1 of 14 possible weekly uses) over 12 weeks. Those who used the device ≥10 times per week were more likely to achieve symptom improvement. In multivariate logistic regression analysis, baseline incontinence symptom severity and maximum angle change during pelvic floor muscle contraction were significantly associated with meeting the UDI-6 minimum clinically important difference. Age, BMI, and UI subtype were not associated. CONCLUSIONS: This study provides real-world evidence to support the effectiveness and safety of a prescribed digital health treatment program for female UI. A digital PFMT program completed with visual guidance from a motion-based device yields significant results when executed ≥10 times per week over a period of 12 weeks. The program demonstrates high user engagement, with 92.9% (880/947) of users adhering to the prescribed training regimen. First-line incontinence treatment, when implemented using this digital program, leads to statistically and clinically substantial symptom improvements across age and BMI categories and incontinence subtypes.

A Motion-based Device Urinary Incontinence Treatment: A Longitudinal Analysis at 18 and 24 Months.

INTRODUCTION AND HYPOTHESIS: There are sparse data regarding the long-term efficacy of pelvic floor muscle training (PFMT) for the treatment of urinary incontinence (UI). The objective of this study was to evaluate the impact of an 8-week PFMT program guided by a motion-based intravaginal device versus a standard home program over 24 months. METHODS: Between October 2020 and March 2021, a total of 363 women with stress or stress-predominant mixed UI were randomized and completed an 8-week PFMT program using a motion-based intravaginal device (intervention group) or a home program following written/video instructions (control group). Participants were not asked to continue training after the 8-week program. At 18 and 24 months' follow-up, the Urogenital Distress Inventory, short-form (UDI-6) and Patient Global Impression of Improvement (PGI-I) were collected. In the original trial, a total of 139 participants in each arm were needed to detect a 0.3 effect size (alpha = 0.05, power 0.8, one-tailed t test) in the difference in UDI-6 scores. RESULTS: A total of 231 participants returned 24-month data. Mean age at 24 months was 51.7 ± 14.5 years, and mean BMI was 31.8 ± 7.4 kg/m2. Mean change in UDI-6 scores from baseline to 24 months was greater in the intervention group than the control group (-21.1 ± 24.5 vs -14.8 ± 19.4, p = 0.04). Reported improvement using PGI-I was greater in the intervention group than in the control group at 24 months (35% vs 22%, p = 0.03, OR 1.95(95% CI 1.08, 3.57). CONCLUSIONS: Pelvic floor muscle training guided by a motion-based prescription intravaginal device yielded durable and significantly greater UI symptom improvement than a standard home program, even in the absence of continued therapy.

Omission of Pelvic Examination Before Gender-Affirming Hysterectomy and Vaginectomy.

Surgeons may be performing pelvic examinations on transgender patients before gender-affirming pelvic surgery (hysterectomy and vaginectomy) without a clinically significant indication. A retrospective cohort study was conducted at a single-institution academic referral center comparing 30-day perioperative outcomes of all 62 gender-affirming pelvic surgeries, including hysterectomy alone, hysterectomy with vaginectomy, and vaginectomy alone, between April 2018 and March 2022. More than half (53.2%, n=33) of the 62 patients did not have an in-office, preoperative, internal pelvic examination within 1 year of gender-affirming surgery. There were no significant differences in patient characteristics nor 30-day perioperative outcomes between the examined and examination-omitted groups, suggesting that omission of a preoperative pelvic examination is probably safe before gender-affirming hysterectomy and vaginectomy, minimizing barriers to gender-affirming surgical care.

Impact of sex and aging on radiographic and functional parameters of the anal sphincter complex in patients with accidental bowel leakage.

AIMS: Treatment outcomes for accidental bowel leakage (ABL) may be influenced by age-related sarcopenia. We sought to determine if thickness of the anal sphincter complex on endoanal ultrasound correlated with function in women and men with ABL and if women demonstrated age-related anal sphincter thinning. METHODS: Consecutive patients with ABL presenting to our pelvic floor clinic from 2012 to 2017 were included. Clinical data were obtained from medical records. External anal sphincter (EAS), imaged by endoanal ultrasound at proximal, mid and distal locations, and IAS thickness were measured at 12, 3, 6, and 9 o'clock; puborectalis muscle (PRM) was measured at 4, 6, and 8 o'clock; and averaged. Anorectal manometry was conducted when clinically indicated. Data were compared using Mann-Whitney tests and linear regression. Results are reported as mean ± SD or median (IQR). RESULTS: Women (n = 136) were younger than men (n = 26) (61 ± 13 vs. 67 ± 13 years, p = 0.02). More women than men had pelvic surgery and less had colorectal surgery, spinal disorders, or a history of smoking (p < 0.05). Eighty-two percentage of women had an anal sphincter defect versus 31% of men (p < 0.01). All anal sphincter complex components were thinner in women than men with lower squeeze and resting pressures (p < 0.03), even in nulliparous women. Mean resting pressure was lower in older 6.1 (4.6-7.8) versus younger women 8.3 (5.0-12.9) mmHg, p = 0.04. CONCLUSIONS: Women, even nulliparous, with ABL demonstrate thinner and weaker anal sphincters than men, Aging correlated with an increase in anal sphincter thickness, suggesting that age-related changes in the intrinsic components of the anal sphincter complex associated with ABL are complex and are not always well demonstrated on endoanal ultrasound.

Digital Therapeutic Device for Urinary Incontinence: A Longitudinal Analysis at 6 and 12 Months.

OBJECTIVE: To evaluate the long-term efficacy of an 8-week regimen of pelvic floor muscle training guided by a motion-based digital therapeutic device compared with a standard home program in the treatment of stress urinary incontinence (SUI) and stress-predominant mixed urinary incontinence (MUI). METHODS: The primary virtual trial was conducted from October 2020 to March 2021; 363 women with SUI or stress-predominant MUI were randomized to complete pelvic floor muscle training using the device (intervention group) or a standard home pelvic floor muscle training program (control group) for 8 weeks. Primary outcomes included change in UDI-6 (Urogenital Distress Inventory, Short Form) score and SUI episodes on a 3-day bladder diary. The PGI-I (Patient Global Impression of Improvement) was also assessed, with "much better" and "very much better" responses considered as improvement. In this planned secondary analysis, symptom and adherence data were collected in follow-up at 6 and 12 months. A modified intention-to-treat analysis was performed using Student's t tests and χ2 tests as appropriate. RESULTS: Of 299 participants analyzed at 8 weeks, 286 (95.7%) returned 6- and 12-month data (151 in the control group, 135 in the intervention group). Mean age was 51.9±12.8 years, and mean body mass index (BMI) was 31.8±7.4; 84.6% of participants were parous, and 54.9% were postmenopausal. Mean change in UDI-6 score from baseline to 6 and 12 months was significantly greater in the intervention group than in the control group (20.2±20.9 vs 14.8±19.5, P=.03 and 22.7±23.3 vs 15.9±20.3, P=.01, respectively). Participants in the intervention group had more than twice the odds of reporting improvement on the PGI-I compared with participants in the control group (OR 2.45, 95% CI 1.49-4.00). CONCLUSION: Pelvic floor muscle training guided by a motion-based digital therapeutic device yielded significantly greater urinary incontinence symptom improvement compared with a standard home pelvic floor muscle training program at 6 and 12 months, although continued improvement waned over time. This technology may facilitate pelvic floor muscle training access and adherence for women with SUI and stress-predominant MUI and represents an effective modality for scaling first-line care. FUNDING SOURCE: Renovia Inc. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04508153.

A digital health program for treatment of urinary incontinence: retrospective review of real-world user data.

INTRODUCTION AND HYPOTHESIS: To determine the effectiveness of a prescription digital therapeutic (pDTx) in reducing urinary incontinence (UI) symptoms in real-world users. METHODS: This is a retrospective cohort study of real-world data from users of a pDTx designed to guide pelvic floor muscle training(PFMT) between July 1, 2020-December 31, 2021. The primary outcome was UI symptom change as reported via in-app Urogenital Distress Inventory (UDI-6). Included subjects were female, ≥ 18 years with a diagnosis of stress, urgency, or mixed UI who completed the UDI-6 at baseline and 8 weeks. Demographic, symptom, and adherence data were summarized. Paired t-test and Wilcoxon signed rank test were used to analyze change in outcomes from baseline to 8 weeks across adherence and UI diagnosis groups. RESULTS: Of 532 women with UI, 265 (50%) met criteria and were included in the analysis. Mean age was 51.2 ± 11.5 years (range 22-84, N = 265). Mean body mass index (BMI) was 27.3 ± 6.2 kg/m2 (range 15.2-46.9, N = 147). Most participants had stress UI (59%) followed by mixed UI (22%), urgency UI/OAB (11%), and unspecified UI (8%). UDI-6 scores improved by 13.90 ± 15.53 (p ≤ 0.001); 62% met or exceeded MCID. Device-reported PFMT adherence was 72% at 4 weeks and 66% at 8 weeks (100% = 14 uses/week). Participants in each diagnosis category reported significant improvement on UDI-6 score from baseline to 8 weeks. No association between UDI-6 score improvement and adherence category, age, BMI, or UI subtype was identified. CONCLUSIONS: This study demonstrates effectiveness of a pDTx in reducing UI symptoms in a real-world setting. Users achieved statistically and clinically significant symptom improvement over an 8-week period.

Digital Therapeutic Device for Urinary Incontinence: A Randomized Controlled Trial.

OBJECTIVE: To evaluate whether pelvic floor muscle training using a motion-based digital intravaginal device is more effective than home pelvic floor muscle training for treatment of stress or stress-predominant mixed urinary incontinence (UI). METHODS: In a remote, virtually executed 8-week prospective randomized controlled superiority trial, women with stress or stress-predominant mixed UI were randomized to pelvic floor muscle training using a motion-based digital therapeutic device or a home training program using written and narrated instructions. Primary outcomes were change in UDI-6 (Urogenital Distress Inventory, Short Form) score and stress urinary incontinence (SUI) episodes on a 3-day bladder diary. A sample size of 139 per group (n=278) was planned to meet the power analysis requirements for the UDI-6 score (n=278) and the bladder diary (n=78). Prespecified secondary outcomes included quality-of-life surveys and adherence reporting. RESULTS: From September 2020 to March 2021, 5,353 participants were screened, and 363 were randomized: 182 in the intervention and 181 in the control group. There were no baseline clinicodemographic differences between groups. The mean change in UDI-6 score was significantly greater for the intervention group compared with the control group (18.8 vs 14.7, P=.01). The median (interquartile range) number of SUI episodes on the 3-day bladder diary was significantly reduced from 5 (3-8) and 5 (3-8) episodes to 1 (0-3) and 2 (1-4) (P=.005) in the intervention group compared with control group, respectively. A significantly greater number of participants in the intervention group than in the control group reported they were "much improved" or "very much improved" on the PGI-I (Patient Global Impression of Improvement) (63/143 [44.1% vs 45/156 [28.8%], odds ratio 1.94, 95% CI 1.21-3.15). There were no device-related severe adverse events. CONCLUSION: In this all-remote, virtually conducted trial, pelvic floor muscle training guided by a motion-based digital therapeutic device resulted in significantly improved UI symptoms and reduction of UI episodes compared with a home training program. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04508153. FUNDING SOURCE: Renovia Inc.

Rectoceles: Is There a Correlation Between Presence of Vaginal Prolapse and Radiographic Findings in Symptomatic Women?

BACKGROUND: Constipation is highly prevalent. Women with constipation are evaluated for the presence of vaginal prolapse that may contribute to obstructed defecation syndrome. Defecography can identify anatomic causes of obstructed defecation syndrome (rectocele, intussusception, and enterocele). OBJECTIVE: This study aimed to assess the characteristics of women with obstructed defecation syndrome and radiographic rectoceles with and without posterior vaginal wall prolapse and to characterize the relationship between anatomical abnormalities and dysfunction. DESIGN: This is a retrospective case-control study of women with obstructed defecation syndrome who had radiographic rectoceles on defecography. SETTINGS: Women who presented to a Pelvic Floor Disorders Center were included. PATIENTS: Cases were defined as constipated women with radiographic rectoceles and at least stage II posterior vaginal wall prolapse on examination. Controls were patients with radiographic rectoceles but without posterior vaginal wall prolapse on examination. MAIN OUTCOME MEASURES: Patient characteristics, anorectal testing results, and validated questionnaires were compared between groups. RESULTS: A total of 106 women met inclusion criteria. Women with posterior vaginal wall prolapse (48 (45.3%)) had larger rectoceles on defecography than women without it on examination (3.4 cm vs 3.0 cm, p < 0.01). Women with posterior vaginal wall prolapse on examination were more likely to splint during defecation than women without vaginal wall prolapse (63.8% vs 27.3%, p < 0.01). All other defecatory symptoms, anorectal manometry parameters, and questionnaire responses were similar between groups. LIMITATIONS: This study was limited by its retrospective study design. Our data were taken from a single institution within a center specializing in the treatment of pelvic floor disorders, potentially limiting generalizability. CONCLUSIONS: Patients with constipation, radiographic rectoceles, and vaginal prolapse may differ from those without evidence of prolapse. Patients with vaginal prolapse were more likely to splint to aide evacuation and demonstrated larger rectoceles on defecography. Further studies are needed to determine whether constipation causes progression along this continuum or whether progression of prolapse is a cause of worsening defecatory dysfunction. See Video Abstract at http://links.lww.com/DCR/B626. RECTOCELES EXISTE UNA CORRELACIN ENTRE LA PRESENCIA DE PROLAPSO VAGINAL Y LOS HALLAZGOS RADIOLGICOS EN MUJERES SINTOMTICAS: ANTECEDENTES:El estreñimiento es una enfermedad muy prevalente. Las mujeres con estreñimiento se evalúan para detectar la presencia de prolapso vaginal que pueda contribuir al síndrome de defecación obstructiva. La defecografía puede identificar las causas anatómicas del síndrome de defecación obstructiva (rectocele, invaginación intestinal (intususcepción) y enterocele).OBJETIVO:Este estudio tiene como objetivo evaluar las características de las mujeres con síndrome de defecación obstructiva y la presencia de rectocele como hallazgo radiológico, con y sin prolapso de la pared vaginal posterior, y caracterizar la relación entre las anomalías anatómicas y la presencia de disfunción.DISEÑO:Este es un estudio retrospectivo de casos y controles, de mujeres con síndrome de defecación obstructiva, que tenían rectocele como hallazgo radiológico en una defecografía.MARCO:Mujeres que acudieron a un Centro de Trastornos del Piso Pélvico.PACIENTES:Los casos fueron definidos como mujeres con estreñimiento con hallazgos radiológicos de rectocele, con al menos un prolapso estadio II de la pared vaginal posterio, en el examen físico. Los controles fueron pacientes con solo rectocele por hallazgos radiológicos, sin prolapso de la pared vaginal posterior en el examen físico.PRINCIPALES MEDIDAS DE RESULTADO:Se compararon entre los grupos: las características de las pacientes, los resultados de las pruebas diagnósticas anorrectales y los cuestionarios validados.RESULTADOS:Un total de 106 mujeres cumplieron los criterios de inclusión. Las mujeres con prolapso de la pared vaginal posterior 48 (45,3%) tenían rectoceles de mayor tamaño en la defecografía en comparación con las mujeres sin rectocele en el examen físico (3,4 cm versus 3,0 cm, p <0,01). Las mujeres con prolapso de la pared vaginal posterior en el examen, tenían una mayor probabilidad de que les fuera necesario ejercer una maniobra de presión manual o digital del periné durante la defecación, comparado con las mujeres sin rectocele clínico (63,8% versus 27,3%, p <0,01). Todos los demás síntomas defecatorios, los parámetros de la manometría anorrectal, y las respuestas al cuestionario fueron similares entre los grupos.LIMITACIONES:Estudio retrospectivo. Los datos fueron obtenidos de la base de datos de un centro especializado en el tratamiento de los trastornos del piso pélvico lo que potencialmente limita generalizar.CONCLUSIONES:Las pacientes con estreñimiento, rectocele como hallazgo radiológico, y prolapso vaginal pueden ser diferentes de aquellas sin evidencia de prolapso. Las pacientes con prolapso vaginal, tenían una mayor probabilidad de que les fuera necesario ejercer maniobras manuales o digitales de presión a nivel del periné para ayudar a la evacuación, y tenían rectoceles de mayor tamaño en la defecografía. Se necesitan más estudios para determinar si el estreñimiento causa que el rectocele aumente progresivamente de tamaño, empeorando la disfunción defecatoria. Consulte Video Resumen en http://links.lww.com/DCR/B626.

Can sonographic fetal head circumference measurement help predict obstetric anal sphincter injury?

OBJECTIVE: To investigate whether sonographic fetal head circumference (sfHC) size assessed by ultrasound prenatally could help predict OASIS. METHODS: This study is a retrospective cohort study between 2005 and 2016. Antenatal sfHC assessment, maternal demographics, and labor and delivery data were abstracted and compared in women with and without OASIS. RESULTS: Of 2057 pregnant women that had sfHC assessment, 121 (5.8%) had OASIS. In the unadjusted analysis, sfHC above the 90th centile was associated with OASIS (odds ratio [OR] 1.12; 95% confidence interval [CI] 1.02-1.23; P = 0.015). When adjusted for gestational age at delivery, maternal age, race, prolonged second stage, body mass index, infant gender, and intrapartum oxytocin use, sfHC above the 90th centile remained significantly associated with OASIS (OR 1.13, 95% CI 1.00-1.27, P = 0.050). CONCLUSION: In our cohort, sfHC above the 90th centile was associated with a greater risk of OASIS. As OASIS significantly impacts both short-term and long-term health outcomes, such as perineal pain, dyspareunia, and urinary and fecal incontinence, sfHC could be an additional prenatal marker to help clinicians counsel pregnant women about the risk of OASIS.

Multicenter Randomized Controlled Trial of Pelvic Floor Muscle Training with a Motion-based Digital Therapeutic Device versus Pelvic Floor Muscle Training Alone for Treatment of Stress-predominant Urinary Incontinence.

OBJECTIVE: To determine whether use of an intravaginal motion-based digital therapeutic device for pelvic floor muscle training (PFMT) was superior to PFMT alone in women with stress-predominant urinary incontinence (SUI). METHODS: A multicenter, randomized-controlled trial was conducted where women with SUI or SUI-predominant mixed urinary incontinence were treated with either PFMT using the device (intervention group) or PFMT alone (control group). Primary outcomes, measured at 8 weeks, included change in Urinary Distress Inventory, short-version and improvement in the Patient Global Impression of Improvement, defined as "much better" or "very much better." Participants also completed Pelvic Organ Prolapse and Colorectal-anal Distress Inventories, Pelvic-Floor-Impact Questionnaire and a 3-day bladder diary. Primary analysis used a modified intention-to-treat approach. Statistical analysis used Student t test and χ2 test. The trial was prematurely halted due to device technical considerations. RESULTS: Seventy-seven women were randomized, and final analysis included 61 participants: 29 in intervention and 32 in control group. There was no statistical difference in Urinary Distress Inventory, short-version scores between the intervention (-13.7 ± 18.7) and the control group (-8.7 ± 21.8; P = 0.85), or in Patient Global Impression of Improvement (intervention 51.7% and control group 40.6%; P = 0.47). Pelvic Organ Prolapse and Colorectal-anal Distress Inventories and Pelvic-Floor-Impact Questionnaire scores improved significantly more in the intervention group than the control group (all P < 0.05). Median number of SUI episodes decreased from baseline to 8 weeks by -1.7 per-day [(-3)-0] in the intervention group and -0.7[(-1)-0] in the control group, (P = 0.047). CONCLUSIONS: In this prematurely terminated trial, there were no statistically significant differences in primary outcomes; however, PFMT with this digital therapeutic device resulted in significantly fewer SUI episodes and greater improvement in symptom-specific quality of life outcomes. A larger powered trial is underway.

Use of a motion-based digital therapeutic in women with fecal incontinence: A pilot study.

AIMS: There is limited data addressing the value of vaginal biofeedback (VBF) on fecal incontinence (FI) symptoms. The objective of this pilot study was to evaluate whether use of a motion-based VBF device and app was effective for at-home treatment of women with FI. We hypothesized that VBF would result in improvement in FI symptoms. METHODS: A single-arm 10-week prospective pilot trial in women with FI was conducted using the VBF device. The primary outcome was change in St. Mark's score from baseline to week 10. Secondary outcomes included change in 2-week bowel diary and FI quality of life (FIQoL). Statistical analysis included paired t test and Wilcoxon's signed-rank test. RESULTS: Of 29 enrolled women, 27 had data available for analysis. Mean (±SD) age was 60.9 (±14.4). 63% (17) subjects were White, 33% (9) were Black. Mean St. Mark's score was 14.6 (±4.4) at baseline and 11.6 (±5.1) at 10-weeks (p = 0.005). Changes in the total FIQol, and three of four subsets of the FIQoL scores were also significantly improved (p < 0.001). Bowel diary showed decrease in FI episodes, baseline 8.4 (±8.73) to 10 weeks 4.8 (±3.79), (p = 0.052). CONCLUSIONS: In this pilot study, there was significant improvement in FI symptom-specific severity and quality of life using a vaginal, motion-based device for biofeedback. A larger study is needed to better understand the value of this device, which may be useful for women who prefer a vaginal device, which can be utilized at home compared with standard anal biofeedback for treatment of FI in the clinical setting.

Consensus Definitions and Interpretation Templates for Magnetic Resonance Imaging of Defecatory Pelvic Floor Disorders: Proceedings of the Consensus Meeting of the Pelvic Floor Disorders Consortium of the American Society of Colon and Rectal Surgeons, the Society of Abdominal Radiology, the International Continence Society, the American Urogynecologic Society, the International Urogynecological Association, and the Society of Gynecologic Surgeons.

The Pelvic Floor Disorders Consortium (PFDC) is a multidisciplinary organization of colorectal surgeons, urogynecologists, urologists, gynecologists, gastroenterologists, radiologists, physiotherapists, and other advanced care practitioners. Specialists from these fields are all dedicated to the diagnosis and management of patients with pelvic floor conditions, but they approach, evaluate, and treat such patients with their own unique perspectives given the differences in their respective training. The PFDC was formed to bridge gaps and enable collaboration between these specialties. The goal of the PFDC is to develop and evaluate educational programs, create clinical guidelines and algorithms, and promote high quality of care in this unique patient population. The recommendations included in this article represent the work of the PFDC Working Group on Magnetic Resonance Imaging of Pelvic Floor Disorders (members listed alphabetically in Table 1). The objective was to generate inclusive, rather than prescriptive, guidance for all practitioners, irrespective of discipline, involved in the evaluation and treatment of patients with pelvic floor disorders.