None listed
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of the PeriCoach Trademark system in females with stress, or mixed with predominantly stress, urinary incontinence as well as the degree of satisfaction of the user in terms of outcome and ease of use.
Interventions
Standard Pelvic floor exercises using PeriCoach biofeedback system
The PeriCoach Sensor unit is switched on, inserted, and paired with the app on the smartphone or tablet. The accompanying smart phone application instructs users to squeeze their pelvic floor muscles at certain timepoints. The biosensors on the device measure the contraction and provide instant feedback to the participant via the app.
The PeriCoach should be used at least once a day with each session lasting 2-4 minutes for the
Standard Pelvic floor exercises using PeriCoach biofeedback system The PeriCoach Sensor unit is switched on, inserted, and paired with the app on the smartphone or tablet. The accompanying smart phone application instructs users to squeeze their pelvic floor muscles at certain timepoints. The biosensors on the device measure the contraction and provide instant feedback to the participant via the app. The PeriCoach should be used at least once a day with each session lasting 2-4 minutes for the period of the trial- 20 weeks. The app uploads the data to a web portal where it is stored and can be accessed by the user, and remotely by the treating clinician (password protected)
Sponsors
Analytica Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Study participant is a female and 18 years or older 2. Study participant is willing and able to sign an informed consent. 3. Study participant demonstrates stress urinary or mixed with predominantly stress, urinary incontinence of mild to moderate severity 4. Study participant willing and able to comply with follow-up activities. 5. Study participant has negative urine culture (using dipstick test) at baseline. (If leucocytes or nitrites present, send for culture. If negative or once treated, the study participant can be included). 6. Study participant has cognitive and manual capability to operate the device as determined by the investigator.
Exclusion criteria
1. Study participant has previously failed conservative incontinence treatment for at least 6 months. Conservative treatment includes one or more of the following: a. Pelvic exercises and bladder training b. Drug Therapy (All anticholinergics, SUI or antidepressants prescribed for treatment of SUI). c. Current use of Biofeedback devices in conjunction with PFT d. Transvaginal/Transcutaneous Electrical stimulation 2. Study participant refuses or is unable to sign the informed consent. 3. Study participant is pregnant or plans to be pregnant as verified by commercially available urine pregnancy test. 4. Study participant cannot comply with study requirements, including follow-up visits and tests. 5. Study participant is currently enrolled or plans to enrol in another investigational device or drug clinical trial or who has just completed an investigational study within 2 weeks. 6. Study participant has been determined to have severe urinary incontinence as confirmed on history taking or by the use of urethral plugs, intermittent or permanent urethral catheterisation. 7. Study participant has recent surgeries within 3 months or planned surgeries during the course of the study. 8. Study participant is unable to perform PFME due to an inability to perform Pelvic floor muscle contractions. 9. Study participant has a primary urge incontinence, mixed incontinence with a predominant urgency component, or urinary incontinence caused by factors other than stress incontinence. 10. Study participant has current pelvic floor prolapse grade 4 or requiring support device. 11. Study participant has had implantation of an artificial urinary sphincter prosthesis, sling, or other urogenital implant 12. Study participant has had pelvic implant including all mesh products. 13. Study participant has neurogenic bladder dysfunction that is not treatable or controllable by pharmacological or alternative methods. 14. Study participant has uncontrolled diabetes mellitus defined as persistent blood sugar level recordings of >12mmol/l (216. mg/dl) and a glycosylated haemoglobin (HbA1C) of >9% (75mmol/mol) over the preceding 3 months which may affect voiding function. 15. Study participant has current (within last 6 months) genito urinary or gynaecological cancer. 16. Study participant needs self-intermittent catheterization. 17. Study participant has a diagnosed disease (e.g., dementia) that might preclude the study participant from being able to recall or summarize her urinary status. 18. Study participant has a diagnosed disease or medical condition (e.g., Parkinson’s) that might preclude the study participant from being physically capable of manipulating the device. 19. Study participant has known allergy to device material (silicone). 20. Study participant has active (confirmed by laboratory urinalysis) or recurrent urinary tract infections (UTIs) where recurrent is defined as > 4 times over the past year. 21. Study participant has known anatomic abnormalities of the urethra or vagina judged to prevent placement and utilisation of the Investigational Device or is assessed as having an anatomic abnormality during the physical examination at screening).
Outcome results
None listed