Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04071301
Other study ID # FUEL_CIP_Ver.B_19-Jul-2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 5, 2019
Est. completion date November 27, 2019

Study information

Verified date May 2021
Source Essity Hygiene and Health AB
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is an explorative, open, single-arm clinical investigation to collect real-life measurement data in order to assess the mathematical algorithms involved in TENA SmartCare Change Indicator.


Description:

The purpose of this exploratory clinical investigation is to evaluate safety and to collect real-life measurement data using the TENA SmartCare Change Indicator. The collected data will be used to assess the device related algorithms. These algorithms have been established and verified in a laboratory environment. However, due to possible differences in parameters, real-life measurement data are to be collected to aid in further product development.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date November 27, 2019
Est. primary completion date November 27, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. The subject is willing and able to provide informed consent and to participate in the clinical investigation. 2. The subject is =18 years of age. 3. The subject is diagnosed with urinary incontinence. 4. The subject is being cared for at Tre Stiftelser. Exclusion Criteria: 1. The subject has = 4 fecal "incidences" per week. 2. The subject has severe absorbent product related skin problems, as judged by the investigator. 3. The subject is hyper sensitive related to allergic reaction to any of the included materials, as judged by the investigator. 4. The subject has = 2 intermittent urinary catheters per day. 5. The subject has a pacemaker or an implantable cardioverter-defibrillator. 6. The subject removes the incontinence product. 7. The subject demonstrates responsive behavior towards sensors. 8. The subject has any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator. 9. The subject is not cared for at Tre Stiftelser. 10. The subject is pregnant or lactating.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
TENA SmartCare Change Indicator
Each participating subject will be provided with a Change Indicator and absorbent products for the duration of the investigation. Nine types of absorbent products will be used to collect real-life measurement data in order to assess the mathematical algorithms involved in the TENA SmartCare Change Indicator. Each participating subject will be allocated to the type(s) that are considered most suitable. Gateways will be placed in the resident's rooms as well as in common areas, this to enable full measurement registration.

Locations

Country Name City State
Sweden Tre Stiftelser Gothenburg

Sponsors (1)

Lead Sponsor Collaborator
Essity Hygiene and Health AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Urine Volume Quantification and Impedance Measurements Descriptive statistics were used to summarize any individual differences between the predicted urine volume from the Change Indicator and the true urine volume (by measuring absorbent product weight). A measure of mean difference for the predicted volume minus true volume is assessed. A combination of these values were used to assess the mathematical algorithms for the TENA SmartCare Change Indicator. 11 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05534412 - A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Incontinence N/A
Recruiting NCT05515198 - Improving Care for Women With Urinary Incontinence (EMPOWER) N/A
Completed NCT03623880 - Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders N/A
Recruiting NCT05880862 - Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls Early Phase 1
Recruiting NCT04159467 - Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet N/A
Completed NCT05485922 - Performance of a Single-use Intermittent Micro-hole Zone Catheter N/A
Completed NCT06268782 - The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women N/A
Not yet recruiting NCT03027986 - Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy N/A
Recruiting NCT02490917 - ACT™ Balloons Versus Artificial Urinary Sphincter (AMS800™) for the Treatment of Female Stress Urinary Incontinence N/A
Enrolling by invitation NCT02529371 - Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients N/A
Enrolling by invitation NCT02530372 - Feasibility of the UriCap-F for Urine Collection in Hospitalized Women N/A
Completed NCT02600676 - Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis N/A
Completed NCT02549729 - Effect of the Pelvic Floor Training in Postmenopausal Women With or Without Hormonal Therapy N/A
Completed NCT02338726 - Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study N/A
Completed NCT02368262 - Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy N/A
Completed NCT02239796 - Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence N/A
Completed NCT01942681 - Female Patients With Signs of uRgE and Stress Urinary Incontinence Study of Propiverine Hydrochloride N/A
Recruiting NCT01804153 - Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO) Phase 1/Phase 2
Completed NCT01520948 - Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease Phase 3
Completed NCT01479816 - Urinary Continence Index for Prediction of Urinary Incontinence in Older Women N/A