A Disposable Intravaginal Device for the Management of Stress Urinary Incontinence

Abstract

Urinary incontinence affects many women over the age of 50 with a substantial detrimental effect on daily activities and the quality of life. Surgical treatments are invasive, expensive, and not always successful. Patients are also treated with a variety of nonsurgical therapies (physical therapy, pharmaceutical interventions, and various vaginal and urethral inserts), but these have poor compliance rates and limited efficacy in patients with mild to moderate stress urinary incontinence (SUI). Incontinence pessaries have demonstrated efficacy in the treatment of SUI but can cause vaginal erosion, foul vaginal odors, and other complications associated with their prolonged residence in the vagina.A novel disposable intravaginal device, which can be worn during active hours and then discarded, was evaluated in this study for safety, ease of use, and efficacy in the treatment of SUI. Fifty-seven women with an average of one episode of SUI per day were fitted with the device, allowed to acclimate to wearing it during the day, and then asked wear the device and pre-weighed incontinence pads for 12 hours a day.Use of this device was significantly associated with a statistically significant decrease in SUI episodes, a decrease in unintentional urine output, a decrease in self-reported bladder control difficulty, and a self-reported improvement in quality of life. Subjects rated the comfort of device use during the fitting period, as well as during later device usage. No serious adverse events were reported. Results show that the intravaginal device is safe, relatively comfortable, and effective at reducing the frequency and psychosocial impact of SUI.

Efficacy, effectiveness, usability and acceptability of devices for female urinary incontinence: A scoping review

“…Twenty‐one articles were selected among which 2 systematic reviews (Lipp et al, 2014; Mugita et al, 2021), 1 randomised controlled trial (Sugama et al, 2012), 1 quasi experimental study (Teerawattananon et al, 2015), 1 prospective interventional cohort study (Moore et al, 2021), 1 prospective descriptive study (Motta & Milne, 2017), 2 cross‐sectional descriptive studies (Grzybowska & Wydra, 2017; Gümüşsoy et al, 2019), 2 retrospective studies (Warren et al, 2021; Zavodnick et al, 2020), 1 product evaluation trial (Long et al, 2015), 1 pilot study (Jeong et al, 2016), 1 open‐label uncontrolled trial (Farage et al, 2011), 1 cost analysis study (Fader et al, 2010), 1 quality improvement project (Eckert et al, 2020), 1 qualitative study (Ostaszkiewicz et al, 2018; Raepsaet et al, 2021), 1 case study (Beeson & Davis, 2018), 4 conference paper (Dublynn & Episcopia, 2019; Fritsch et al, 2019; Maydick‐Youngberg et al, 2020; Mueller, 2019; Peters et al, 2021).…”

“…The devices explored in the studies were as follows: female external urinary catheter, an external device used to manage urinary incontinence in a no‐invasive way in women without cognitive impairment, faecal incontinence, perineal wounds or even with menstruation (Beeson & Davis, 2018; Dublynn & Episcopia, 2019; Eckert et al, 2020; Fritsch et al, 2019; Mueller, 2019; Peters et al, 2021; Warren et al, 2021; Zavodnick et al, 2020); pads, disposable diapers or under‐pads used to manage both urinary and faecal incontinence in women and men (Grzybowska & Wydra, 2017; Gümüşsoy et al, 2019; Ostaszkiewicz et al, 2018; Sugama et al, 2012; Teerawattananon et al, 2015); mechanical devices, such as a continence dish, positioned to sit underneath the urethra, creating a support similar to the sub urethral sling, such as pessary or disposable intravaginal device, a single‐use and disposable device, which provide tension‐free support whenever the pressure is transferred from the abdominal cavity to the pelvic floor, or such as tampon (Farage et al, 2011; Lipp et al, 2014; Moore et al, 2021), a new prototype of underwear described as a pair of washable fixation pants with sewn‐in conductive threads that track where pads leak (Long et al, 2015), reusable underwear market for light incontinence (urinary leakage volumes up to approximately 25–30 ml daily), designed to be worn all day and machine washable (Alam et al, 2020), a new intelligent system pad, a system comprises of a urine collection cup made of medical‐grade silicone, a connecting hose between the urinal cup and the main body (Jeong et al, 2016). A summary of results is reported in Table 2.…”

“…Mechanical devices also emerged from this review. In terms of efficacy and effectiveness related to stress urinary incontinence (SUI), Farage et al (2011) suggested that after 2 weeks of daily device use, stress urinary incontinence episodes reduced and perceived QoL improved. Moore et al (2021) reports that using a new continence dish, female patients with stress incontinence reported improvement on the International Consultation on Incontinence Questionnaire (ICIQ) and in the visual analogue patient satisfaction score.…”

“…Safety was reported in terms of urinary tract infections by Lipp et al (2014) stated that there was no statistically significant difference in urinary tract infections using mechanical devices than intraurethral devices. In terms of safety related to gynaecological clinical changes Farage et al (2011) reported non‐significant clinical changes in patient's examinations after 2 weeks of daily device use. Moore found different results, 7.7% (7/91 patients) reported adverse effects: 3.3% reported pain while using the continence dish, 2.2% reported vaginal bleeding, and 1.1% reported erosion and thrush.…”

Efficacy, effectiveness, usability and acceptability of devices for female urinary incontinence: A scoping review

“…Twenty‐one articles were selected among which 2 systematic reviews (Lipp et al, 2014; Mugita et al, 2021), 1 randomised controlled trial (Sugama et al, 2012), 1 quasi experimental study (Teerawattananon et al, 2015), 1 prospective interventional cohort study (Moore et al, 2021), 1 prospective descriptive study (Motta & Milne, 2017), 2 cross‐sectional descriptive studies (Grzybowska & Wydra, 2017; Gümüşsoy et al, 2019), 2 retrospective studies (Warren et al, 2021; Zavodnick et al, 2020), 1 product evaluation trial (Long et al, 2015), 1 pilot study (Jeong et al, 2016), 1 open‐label uncontrolled trial (Farage et al, 2011), 1 cost analysis study (Fader et al, 2010), 1 quality improvement project (Eckert et al, 2020), 1 qualitative study (Ostaszkiewicz et al, 2018; Raepsaet et al, 2021), 1 case study (Beeson & Davis, 2018), 4 conference paper (Dublynn & Episcopia, 2019; Fritsch et al, 2019; Maydick‐Youngberg et al, 2020; Mueller, 2019; Peters et al, 2021).…”

“…The devices explored in the studies were as follows: female external urinary catheter, an external device used to manage urinary incontinence in a no‐invasive way in women without cognitive impairment, faecal incontinence, perineal wounds or even with menstruation (Beeson & Davis, 2018; Dublynn & Episcopia, 2019; Eckert et al, 2020; Fritsch et al, 2019; Mueller, 2019; Peters et al, 2021; Warren et al, 2021; Zavodnick et al, 2020); pads, disposable diapers or under‐pads used to manage both urinary and faecal incontinence in women and men (Grzybowska & Wydra, 2017; Gümüşsoy et al, 2019; Ostaszkiewicz et al, 2018; Sugama et al, 2012; Teerawattananon et al, 2015); mechanical devices, such as a continence dish, positioned to sit underneath the urethra, creating a support similar to the sub urethral sling, such as pessary or disposable intravaginal device, a single‐use and disposable device, which provide tension‐free support whenever the pressure is transferred from the abdominal cavity to the pelvic floor, or such as tampon (Farage et al, 2011; Lipp et al, 2014; Moore et al, 2021), a new prototype of underwear described as a pair of washable fixation pants with sewn‐in conductive threads that track where pads leak (Long et al, 2015), reusable underwear market for light incontinence (urinary leakage volumes up to approximately 25–30 ml daily), designed to be worn all day and machine washable (Alam et al, 2020), a new intelligent system pad, a system comprises of a urine collection cup made of medical‐grade silicone, a connecting hose between the urinal cup and the main body (Jeong et al, 2016). A summary of results is reported in Table 2.…”

“…Mechanical devices also emerged from this review. In terms of efficacy and effectiveness related to stress urinary incontinence (SUI), Farage et al (2011) suggested that after 2 weeks of daily device use, stress urinary incontinence episodes reduced and perceived QoL improved. Moore et al (2021) reports that using a new continence dish, female patients with stress incontinence reported improvement on the International Consultation on Incontinence Questionnaire (ICIQ) and in the visual analogue patient satisfaction score.…”

“…Safety was reported in terms of urinary tract infections by Lipp et al (2014) stated that there was no statistically significant difference in urinary tract infections using mechanical devices than intraurethral devices. In terms of safety related to gynaecological clinical changes Farage et al (2011) reported non‐significant clinical changes in patient's examinations after 2 weeks of daily device use. Moore found different results, 7.7% (7/91 patients) reported adverse effects: 3.3% reported pain while using the continence dish, 2.2% reported vaginal bleeding, and 1.1% reported erosion and thrush.…”

A feasibility study with a novel, dynamic, and disposable over‐the‐counter device for the management of stress urinary incontinence

“…An additional study on a novel, disposable intravaginal device (ConTIPI Ltd.), required that women use the device for 8 h a day, and found that 85% of participants achieved a 70% reduction in PWG ( p = .01) from the control period to the last 14 days of device usage 17 . Another study on this same intravaginal device asked women to wear the device for 12 h a day, and found that a PWG decreased significantly from the base line period (median: 1.5 g/12‐h wear period) to the last 5 days of the 14‐day device usage period (median: 0.22 g/12‐h wear period ( p < .0001) 18 …”

Efficacy, effectiveness, usability and acceptability of devices for female urinary incontinence: A scoping review

“…Twenty‐one articles were selected among which 2 systematic reviews (Lipp et al, 2014; Mugita et al, 2021), 1 randomised controlled trial (Sugama et al, 2012), 1 quasi experimental study (Teerawattananon et al, 2015), 1 prospective interventional cohort study (Moore et al, 2021), 1 prospective descriptive study (Motta & Milne, 2017), 2 cross‐sectional descriptive studies (Grzybowska & Wydra, 2017; Gümüşsoy et al, 2019), 2 retrospective studies (Warren et al, 2021; Zavodnick et al, 2020), 1 product evaluation trial (Long et al, 2015), 1 pilot study (Jeong et al, 2016), 1 open‐label uncontrolled trial (Farage et al, 2011), 1 cost analysis study (Fader et al, 2010), 1 quality improvement project (Eckert et al, 2020), 1 qualitative study (Ostaszkiewicz et al, 2018; Raepsaet et al, 2021), 1 case study (Beeson & Davis, 2018), 4 conference paper (Dublynn & Episcopia, 2019; Fritsch et al, 2019; Maydick‐Youngberg et al, 2020; Mueller, 2019; Peters et al, 2021).…”

“…The devices explored in the studies were as follows: female external urinary catheter, an external device used to manage urinary incontinence in a no‐invasive way in women without cognitive impairment, faecal incontinence, perineal wounds or even with menstruation (Beeson & Davis, 2018; Dublynn & Episcopia, 2019; Eckert et al, 2020; Fritsch et al, 2019; Mueller, 2019; Peters et al, 2021; Warren et al, 2021; Zavodnick et al, 2020); pads, disposable diapers or under‐pads used to manage both urinary and faecal incontinence in women and men (Grzybowska & Wydra, 2017; Gümüşsoy et al, 2019; Ostaszkiewicz et al, 2018; Sugama et al, 2012; Teerawattananon et al, 2015); mechanical devices, such as a continence dish, positioned to sit underneath the urethra, creating a support similar to the sub urethral sling, such as pessary or disposable intravaginal device, a single‐use and disposable device, which provide tension‐free support whenever the pressure is transferred from the abdominal cavity to the pelvic floor, or such as tampon (Farage et al, 2011; Lipp et al, 2014; Moore et al, 2021), a new prototype of underwear described as a pair of washable fixation pants with sewn‐in conductive threads that track where pads leak (Long et al, 2015), reusable underwear market for light incontinence (urinary leakage volumes up to approximately 25–30 ml daily), designed to be worn all day and machine washable (Alam et al, 2020), a new intelligent system pad, a system comprises of a urine collection cup made of medical‐grade silicone, a connecting hose between the urinal cup and the main body (Jeong et al, 2016). A summary of results is reported in Table 2.…”

“…Mechanical devices also emerged from this review. In terms of efficacy and effectiveness related to stress urinary incontinence (SUI), Farage et al (2011) suggested that after 2 weeks of daily device use, stress urinary incontinence episodes reduced and perceived QoL improved. Moore et al (2021) reports that using a new continence dish, female patients with stress incontinence reported improvement on the International Consultation on Incontinence Questionnaire (ICIQ) and in the visual analogue patient satisfaction score.…”

“…Safety was reported in terms of urinary tract infections by Lipp et al (2014) stated that there was no statistically significant difference in urinary tract infections using mechanical devices than intraurethral devices. In terms of safety related to gynaecological clinical changes Farage et al (2011) reported non‐significant clinical changes in patient's examinations after 2 weeks of daily device use. Moore found different results, 7.7% (7/91 patients) reported adverse effects: 3.3% reported pain while using the continence dish, 2.2% reported vaginal bleeding, and 1.1% reported erosion and thrush.…”

A feasibility study with a novel, dynamic, and disposable over‐the‐counter device for the management of stress urinary incontinence

“…An additional study on a novel, disposable intravaginal device (ConTIPI Ltd.), required that women use the device for 8 h a day, and found that 85% of participants achieved a 70% reduction in PWG ( p = .01) from the control period to the last 14 days of device usage 17 . Another study on this same intravaginal device asked women to wear the device for 12 h a day, and found that a PWG decreased significantly from the base line period (median: 1.5 g/12‐h wear period) to the last 5 days of the 14‐day device usage period (median: 0.22 g/12‐h wear period ( p < .0001) 18 …”

Efficacy, effectiveness, usability and acceptability of devices for female urinary incontinence: A scoping review

“…Twenty‐one articles were selected among which 2 systematic reviews (Lipp et al, 2014; Mugita et al, 2021), 1 randomised controlled trial (Sugama et al, 2012), 1 quasi experimental study (Teerawattananon et al, 2015), 1 prospective interventional cohort study (Moore et al, 2021), 1 prospective descriptive study (Motta & Milne, 2017), 2 cross‐sectional descriptive studies (Grzybowska & Wydra, 2017; Gümüşsoy et al, 2019), 2 retrospective studies (Warren et al, 2021; Zavodnick et al, 2020), 1 product evaluation trial (Long et al, 2015), 1 pilot study (Jeong et al, 2016), 1 open‐label uncontrolled trial (Farage et al, 2011), 1 cost analysis study (Fader et al, 2010), 1 quality improvement project (Eckert et al, 2020), 1 qualitative study (Ostaszkiewicz et al, 2018; Raepsaet et al, 2021), 1 case study (Beeson & Davis, 2018), 4 conference paper (Dublynn & Episcopia, 2019; Fritsch et al, 2019; Maydick‐Youngberg et al, 2020; Mueller, 2019; Peters et al, 2021).…”

“…The devices explored in the studies were as follows: female external urinary catheter, an external device used to manage urinary incontinence in a no‐invasive way in women without cognitive impairment, faecal incontinence, perineal wounds or even with menstruation (Beeson & Davis, 2018; Dublynn & Episcopia, 2019; Eckert et al, 2020; Fritsch et al, 2019; Mueller, 2019; Peters et al, 2021; Warren et al, 2021; Zavodnick et al, 2020); pads, disposable diapers or under‐pads used to manage both urinary and faecal incontinence in women and men (Grzybowska & Wydra, 2017; Gümüşsoy et al, 2019; Ostaszkiewicz et al, 2018; Sugama et al, 2012; Teerawattananon et al, 2015); mechanical devices, such as a continence dish, positioned to sit underneath the urethra, creating a support similar to the sub urethral sling, such as pessary or disposable intravaginal device, a single‐use and disposable device, which provide tension‐free support whenever the pressure is transferred from the abdominal cavity to the pelvic floor, or such as tampon (Farage et al, 2011; Lipp et al, 2014; Moore et al, 2021), a new prototype of underwear described as a pair of washable fixation pants with sewn‐in conductive threads that track where pads leak (Long et al, 2015), reusable underwear market for light incontinence (urinary leakage volumes up to approximately 25–30 ml daily), designed to be worn all day and machine washable (Alam et al, 2020), a new intelligent system pad, a system comprises of a urine collection cup made of medical‐grade silicone, a connecting hose between the urinal cup and the main body (Jeong et al, 2016). A summary of results is reported in Table 2.…”

“…Mechanical devices also emerged from this review. In terms of efficacy and effectiveness related to stress urinary incontinence (SUI), Farage et al (2011) suggested that after 2 weeks of daily device use, stress urinary incontinence episodes reduced and perceived QoL improved. Moore et al (2021) reports that using a new continence dish, female patients with stress incontinence reported improvement on the International Consultation on Incontinence Questionnaire (ICIQ) and in the visual analogue patient satisfaction score.…”

“…Safety was reported in terms of urinary tract infections by Lipp et al (2014) stated that there was no statistically significant difference in urinary tract infections using mechanical devices than intraurethral devices. In terms of safety related to gynaecological clinical changes Farage et al (2011) reported non‐significant clinical changes in patient's examinations after 2 weeks of daily device use. Moore found different results, 7.7% (7/91 patients) reported adverse effects: 3.3% reported pain while using the continence dish, 2.2% reported vaginal bleeding, and 1.1% reported erosion and thrush.…”

A feasibility study with a novel, dynamic, and disposable over‐the‐counter device for the management of stress urinary incontinence

“…An additional study on a novel, disposable intravaginal device (ConTIPI Ltd.), required that women use the device for 8 h a day, and found that 85% of participants achieved a 70% reduction in PWG ( p = .01) from the control period to the last 14 days of device usage 17 . Another study on this same intravaginal device asked women to wear the device for 12 h a day, and found that a PWG decreased significantly from the base line period (median: 1.5 g/12‐h wear period) to the last 5 days of the 14‐day device usage period (median: 0.22 g/12‐h wear period ( p < .0001) 18 …”