Devices For Stress Urinary Incontinence Research Articles

Current State of Non-surgical Devices for Female Stress Urinary Incontinence.

The purpose of this review is to summarize and assess the current non-surgical devices for the treatment of stress urinary incontinence (SUI). Devices for SUI can generally be divided into two categories. One category is the augmentation of pelvic floor muscle training (PFMT), wherein devices such as vaginal cones, intravaginal biofeedback, and electrical or magnetic stimulation are used to strength the pelvic floor musculature, though none are more effective than traditional PFMT. The second category of devices mechanically occludes the outlet and includes incontinence pessaries, intravaginal occlusion devices, and urethral plugs and patches. While these are palliative rather than curative, they share similar rates of improvement in leakage. A number of novel devices exist for the treatment and management of SUI. Though no single device has been shown to be more effective than PFMT alone, they may be beneficial for women who have difficulty isolating their pelvic floor muscles, desire accountability, or prefer technology-based engagement. Outlet occlusion devices are less comfortable for the patient, but remain an option for women who do not desire surgery.

Characterizing Adverse Events Reporting for an Over-the-Counter Disposable Intravaginal Support Device for Stress Urinary Incontinence.

In recent years, new intravaginal support devices for stress urinary incontinence have been introduced to the market. Although studies have demonstrated their safety and efficacy, few studies have examined adverse events attributed to their use. The objective of this study was to characterize reported adverse events for an over-the-counter intravaginal support device and determine whether further medical treatment was necessary to manage the adverse event. We searched the Manufacturer and User Device Experience database from January 2015 to September 2020 for pertinent reported adverse events, which included the unique report key, event date, report date, event text descriptions, and resulting course of treatment. Per Manufacturer and User Device Experience database mandatory requirements, all reports were submitted by the manufacturer within 30 days of receiving the consumer's voluntary submission. A total of 257 reports were included for analysis. The most common reported adverse event was related to the string of the device, which broke with either removal or insertion of the device (230 of 257 [89.5%]). The majority of patients who required medical attention (133 of 257 [51.8%]) were evaluated and managed in the office setting (85 of 133 [63.9%]), whereas 37% (95 of 257) of patients were able to self-treat. Most complications attributed to device use were self-managed or managed in the outpatient setting. No emergent hospitalizations or deaths were attributed to their use, supporting their generally low-risk profile and high tolerability. Limitations of this review include the inability to decipher a denominator for these reported adverse events and the potential bias attributed to voluntary consumer reporting.

Safety and Efficacy of a Disposable Vaginal Device for Stress Urinary Incontinence.

The aim of this study was to evaluate the efficacy and safety of an over-the-counter device for the treatment of stress urinary incontinence (SUI) in females. A multicenter, interventional, single-arm study involving 5 different sites was conducted including women diagnosed with symptomatic SUI using a self-inserted pessary device. A 1-week baseline period was followed by a 2-week period of wearing the device. The main outcome of our study was to determine if the device was able to reduce at least 50% the number of leakage events and pad weight. Across all study sites, 73 subjects were enrolled and 51 completed the study. Efficacy analyses were conducted on the modified intent-to-treat population (n = 48), whereas the safety analysis was conducted on all consented participants. The average pad weight gain was 0.9 g/h at baseline and 0.5 g/h during the treatment phase. The number of leakage episodes per day decreased from 2 at baseline to 0.9 during the treatment phase (P < 0.0001). Seventy-one percent of the study population experienced a more than 50% reduction in leakage volume, leakage episodes, or both. The quality of life scores improved from baseline to posttreatment phase by 4.35 points on average (P < 0.0001). A total of 40 adverse events were recorded, and only 4 subjects withdrew due to adverse events. The self-deployable pessary device evaluated in this study is an alternative option for women seeking an over-the-counter method to manage symptoms of SUI. Further studies are required to determine the long-term effects and compliance using the device.

Electrical stimulation with non-implanted devices for stress urinary incontinence in women.

Electrical stimulation with non-implanted devices for stress urinary incontinence in women.

Electrical stimulation with non-implanted devices for stress urinary incontinence in women

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the effectiveness of electrical stimulation with non‐implanted devices, alone or in combination with other treatment, in the management of stress urinary incontinence or stress‐predominant mixed urinary incontinence in women.

Single incision device (TVT Secur) versus retropubic tension-free vaginal tape device (TVT) for the management of stress urinary incontinence in women: a randomized clinical trial.

BackgroundIn 2006, Ethicon Inc. introduced a new minimally invasive single incision sling device for the surgical treatment of stress urinary incontinence, the Gynecare TVT Secur®. For device licensing, no new evidence of TVT Secur efficacy and safety was needed: rather evidence was provided of the long-term follow-up of patients who had a procedure using a predecate retropubic tension-free vaginal tape device. Before adopting TVT Secur into our routine clinical practice, we decided to evaluate it. The objective of our Canadian multi-centre pragmatic randomized controlled trial was to compare the effectiveness of the new single-incision device, TVT Secur, to the established TVT device, in terms of objective cure of stress urinary incontinence (SUI) at 12 months postoperatively. Other outcomes included: complications, symptoms, and incontinence-related quality of life.ResultsThe sample size estimate for our trial was 300, but the trial stopped early because of poor recruitment. 74 women participated (40 allocated to TVT Secur, 34 to TVT). At 12 months postoperatively, 27/33(82%) of TVT Secur group were cured, compared with 25/28(89%) of the TVT group (relative risk 0.92, 95% confidence interval 0.75 to 1.13, p = 0.49). Most women reported little or no SUI symptoms (35/37(95%) vs 29/30(97%), >0.999). Quality of life improved significantly from baseline for both groups (IIQ-7 mean change −25 for both groups) but did not differ between groups (p = 0.880).ConclusionOur small randomized trial did not find statistically significant differences in outcomes between women allocated to the TVT Secur device versus those allocated to the TVT device for stress urinary incontinence. Despite the discontinuation of TVT Secur in March 2013 for commercial reasons, the importance of our study lies in making evidence available for the many women who had a TVT Secur device implanted and their physicians who may be considering alternative treatments. Our experience illustrates the difficulty of undertaking research on new licensed devices in a rapidly changing surgical specialty, and further highlights the need for research before licensing if surgeons and their patients are to be confident in the effectiveness and safety of new surgical devices.Trial registrationClinicalTrials.gov NCT00685217, 22 May 2008.

Significant improvement in the quality of life in women treated with a novel disposable intravaginal device for stress urinary incontinence

The aim of the study was to assess the quality of life (QoL) in women with stress urinary incontinence (SUI) while using a novel disposable intravaginal device. Fifty women with severe SUI who completed a 7-day control period followed by a 28-day device usage period underwent QoL assessments based on two validated questionnaires, the Incontinence Impact Questionnaire (IIQ-7) and the Urogenital Distress Inventory (UDI-6). Mean total score for the IIQ-7 decreased from 41.8 +/- 24.1 to 4.4 +/- 8.7 at the pre- and poststudy visits, respectively (P < 0.001). The mean total score for the UDI-6 decreased from 48.2 +/- 16.1 to 11.5 +/- 11.9 at the pre- and poststudy visits, respectively (P < 0.001). Statistically significant decreases in most subscale scores were observed by the end of the study for both questionnaires (all P values <0.001). The novel disposable intravaginal device significantly improved QoL in women with SUI.

The effect of aging on the electromyographic activity of pelvic floor muscles: A comparative study among stress incontinent patients and asymptomatic women

Objectives: Pelvic floor muscle training (PFMT) is commonly used in combination with biofeedback devices for stress urinary incontinence. A new electromyography (EMG)-based home-use device for PFMT is tested for healthy and stress incontinent patients. Subjects and methods: Altogether 31 women with genuine stress incontinence (GSI) and 35 controls without urinary symptoms were measured with a vaginal surface EMG probe. EMG activity during three rapid contractions (5 s) in supine and standing positions were observed. Results: Mean values of three rapid contractions were 17.0 μV (range 6.5–59.0, S.D. 10.5) in the supine position and 12.9 μV (range 5.0–33.0, S.D. 5.9) in the standing position among incontinent patients and 19.5 μV (range 9.0–43.5, S.D. 8.4) and 18.2 μV (range 8.0–43.5, S.D. 8.7) among the controls, respectively. A significant difference ( P=0.006) was found in the mean values of three rapid contractions in the standing position between GSI patients and asymptomatic women. In regression analysis, EMG values were dependent on age ( P=0.004 in the supine, P=0.009 in the standing) in both groups, but not on parity, body mass index (BMI) or episiotomies. Conclusions: In the study groups, the EMG activity of pelvic floor muscles (PFMs) decreased during aging. Although the tested surface EMG device showed a tendency that incontinent patients have lower PFM activities especially in the standing position, the value of surface EMG method as a diagnostic tool is not well established. However, the tested EMG-based device for PFMT will be helpful as guidance for incontinent patients.

New External Device for Stress Urinary Incontinence

Stress urinary incontinence (SUI) is an embarrassing problem for up to 30% of postmenopausal women. This industry-sponsored study finds that some women