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Pelvic floor muscle training for the treatment of urinary incontinence using a digital therapeutic device shows long-term superior efficacy compared with home pelvic floor muscle training. 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Keywords: Defecography; Dynamic MRI defecogram; MRI defecography; MRI proctogram; Pelvic floor MRI EN Defecography Dynamic MRI defecogram MRI defecography MRI proctogram Pelvic floor MRI 2561 2574 14 09/23/21 20211001 NES 211001 Brooke H. Gurland, Gaurav Khatri, and Roopa Ram contributed equally to this work (first co-authors and chairs of the MRI working group). Rectal intussusception in male or female patients refers to the infolding or telescoping of the rectum into the more distal rectum, anal canal, or through the anal sphincter muscles (external prolapse or full-thickness rectal prolapse) [[31]]. B = bladder; R = rectum; V = vagina Posterior vaginal wall prolapse is often secondary to rectocele, which is defined as anterior bulging or ballooning of the rectum into the rectovaginal septum. The search terms included: "Dynamic MRI", "Dynamic pelvic floor MR", "MR defecography", "Pelvic floor MR", "Positioning for MR defecography", "levator descent", "pelvic organ prolapse", "rectocele", "rectal emptying", "cystocele", "rectal intussusception", "Cul-de-sac hernias pelvic floor", "uterine prolapse", "Vaginal prolapse", "urethral hypermobility", "pubococcygeal line", "pelvic floor dyssynergia", and "anorectal angle.". [Extracted from the article]

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.