Clinical study on Contisphere ® device.
- Conditions
- Stress incontinence (female) (male),
- Registration Number
- CTRI/2021/04/032834
- Lead Sponsor
- Blue Neem Medical Devices Pvt Ltd
- Brief Summary
Urinary incontinence (UI) affects approximately 6.2% of Indian population as per study article- The epidemiology of urinary incontinence conducted by “AUSTRALIAN URINARY CONT INENCE NEEDS ANALYSISâ€. UI imposes significant adverse physical effects on patients as well as having significant psychological impact on individuals, their families and caregivers. UI results in a loss of self-esteem and a decrease in the ability to maintain an independent lifestyle. Consequently, for women with UI, trips outside the home, social interaction with friends and family and sexual activity may be restricted or avoided entirely (Grimby, Milsom, Molander, et al., 1993).
UI can be caused by anatomic, physiologic and pathologic factors affecting the urinary tract. Subtypes of UI include urge incontinence, overflow incontinence and stress incontinence. Women with stress urinary incontinence (SUI) present clinically with involuntary loss of urine during coughing, sneezing, laughing, or other physical activities that increase intra-abdominal pressure. SUI is defined as urine loss coincident with sudden increase in intra-abdominal pressure. The most common cause of SUI in women is urethral hypermobility and may also be caused by an intrinsic urethral sphincter insufficiency (ISI). In ISI, the urethral sphincter is unable to generate enough resistance to remain completely closed to retain urine in the bladder, especially during stress manoeuvres.
Treatment modalities available for patients with SUI can be divided into three major categories: behavioural, pharmacological and surgical. As a general rule, the first choice should be the least invasive treatment with the fewest potential adverse complications that is appropriate for the patient. Although a number of treatment options have been shown to be effective alone or in combination, more research is required to determine the optimum treatment combination for specific treatment groups (Urinary Incontinence in Adults, 1996). The high prevalence of UI and its significant adverse physical and psychological effects clearly justify more aggressive efforts to identify, evaluate and treat UI in all settings. The purpose of this study is to determine if a new incontinence device will provide an additional minimally invasive treatment option for women diagnosed with SUI. The new female incontinence device is designed for placement in the bladder to prevent urine leakage while allowing the patient to control urination naturally.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Female
- Target Recruitment
- 25
1- Female Patient is 18 years or older 2- Patient has a diagnosis of Grade II or III urinary stress incontinence, or intrinsic sphincteric deficiency proven by a positive provocative stress test or Patient (with mixed incontinence) in whom the bladder instability finding is not prominent 3- Patient has positive pad weight test (urine loss within 1 hour  2 g) 4- Patient is a failure of surgical treatment and/or refuses surgical intervention 5- Patient uses appropriate contraception or is post-menopausal 6- Patient is willing to comply with study requirements 7- Patient is capable of giving informed consent.
1-Patient (with mixed incontinence) in whom the bladder instability finding is prominent 2- Patient has an active urinary tract infection or has had 2 diagnosed urinary tract infections in the past 6 months 3- Patient has hematuria that has not been previously evaluated and treated 4- Patient’s status is compromised by interstitial cystitis, severe diabetes, neurogenic bladder, bladder cancer, urethral structures and/or significant genital prolapse 5- Patient is carrying a pacemaker 6- Patient does suffer from reduced bladder sensation 7- Patient is pregnant (pregnancy must be ruled out by a pregnancy test for patients of childbearing potential) 8- Patient has bladder tumors or stones 9- Patient is taking medication that has an effect on continence.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To use 0 to 1 absorbent pad per day less than 7 pads per week valuated for the indwelling period of day 1 90 days of ContiSphere insertion to Day 90 No de-novo UTI during its indwelling period 90 days
- Secondary Outcome Measures
Name Time Method 1.Successful and safe insertion and retrieval of ContiSphere Balloon 2.Less patient discomfort during insertion and retrieval of ContiSphere Balloon as feedback
Trial Locations
- Locations (2)
Santosh Hospital
🇮🇳Bangalore, KARNATAKA, India
Vagus Superspeciality Hospital
🇮🇳Bangalore, KARNATAKA, India
Santosh Hospital🇮🇳Bangalore, KARNATAKA, IndiaDr Syed Zahid RazaPrincipal investigator8310035771syed.zahid.raza@gmail.com