Evaluation of the SENS-U as an alarm intervention in the treatment of children with daytime urinary incontinence
| ISRCTN | ISRCTN44345202 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44345202 |
| Secondary identifying numbers | 80-85200-98-21037 |
- Submission date
- 04/01/2022
- Registration date
- 23/03/2022
- Last edited
- 20/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Urotherapy is the first treatment of choice for functional daytime urinary incontinence (DUI) in children. Alarm therapy can be a part of urotherapy as it provides the child adequate feedback on wetting accidents. Current alarm systems notify either at a set interval or give a notification when wetting has already occurred to prompt the child to go to the toilet. These alarms do not teach the child the interpretation of the bladder sensation preceding wetting accidents. A new wearable bladder sensor, the SENS-U, recently became available. This is a small, wireless ultrasonic sensor, which continuously monitors bladder filling. The SENS-U is able to provide an alarm at the exact moment voiding is warranted. It facilitates the child to learn the sensation of bladder filling preceding voiding in an easier way, increasing the learning curve throughout treatment.
The aim of this multicenter single-blinded randomized controlled trial is to assess the additional effect of continuous ultrasound bladder monitoring in urotherapy for children with functional daytime urinary incontinence.
Who can participate?
Children aged 6 to 16 years old with functional daytime urinary incontinence.
What does the study involve?
Participants will be divided into three groups at random, with each participant having an equal chance of being in each group. Participants will receive either urotherapy only for 3 months, urotherapy for 3 months with 3 consecutive weeks using the SENS-U device, or urotherapy for 3 months with 3 consecutive weeks with the using a sham device.
What are the possible benefits and risks of participating?
By training, subjects might benefit from treatment by reduction in wetting accidents. Potential risks are discomfort or redness of the skin while wearing the device.
Where is the study run from?
Radboud UMC (Netherlands)
When is the study starting and how long is it expected to run for?
From June 2021 to June 2026
Who is funding the study?
ZonMw (Netherlands) and Novioscan (Netherlands)
Who is the main contact?
Eline van de Wetering, Eline.vandewetering@radboudumc.nl
Contact information
Scientific
Geert Grooteplein Zuid 10
Nijmegen
6525 GA
Netherlands
 ORCID ID |
0000-0002-1704-6772 |
|---|---|
| Phone | +31 (0)24 361 3735 |
| secretariaat.uro@radboudumc.nl |
Public
Geert Grooteplein Zuid 10
Nijmegen
6525 GA
Netherlands
| ORCID ID |
0000-0002-9144-1375 |
|---|---|
| Phone | +31615188436 |
| Eline.vandewetering@radboudumc.nl |
Scientific
Lundlaan 6
Utrecht
3584 EA
Netherlands
| ORCID ID |
0000-0002-2841-813X |
|---|---|
| Phone | +31887554111 |
| a.nieuwhof-leppink@umcutrecht.nl |
Study information
| Study design | Multicenter interventional single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | www.de-sensu-studie.nl |
| Scientific title | The SENS-U trial: evaluation of the additional effect of continuous ultrasound bladder monitoring in urotherapy for children with functional daytime urinary incontinence |
| Study acronym | SENS-U |
| Study objectives | Urotherapy combined with the SENS-U reduces the number of wetting accidents per week in children with functional daytime urinary incontinence |
| Ethics approval(s) | Approved 04/01/2022, METC Oost-Nederland (Philips van Leydenlaan 25, 6500 HB Nijmegen; +31 (0)24 3613154; commissiemensgebondenonderzoek@radboudumc.nl), ref: 2021-13134, NL number: NL78403.091.21 |
| Health condition(s) or problem(s) studied | Treatment of children with functional daytime urinary incontinence |
| Intervention | Participants will be divided into 3 arms in a 1:1:1 fashion: 1. Urotherapy only (control group) 2. Urotherapy + SENS-U 3. Urotherapy + Sham-device (placebo) Urotherapy will be given for 3 months. Children who are placed in the SENS-U or Sham-device arm will wear the device for 3 consecutive weeks during the 3 months of urotherapy treatment. The SHAM-device has the exact same appearance as the SENS-U. However, it does not measure the filling state of the bladder. The SHAM-device is programmed to give an alarm at set time intervals. The device can best be compared to alarm interventions such as the timer watch. Outcome parameters will be measured at baseline, after the end of 3-weeks intensive training with diary, after 3 months, and at 6 months after starting training. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase III/IV |
| Drug / device / biological / vaccine name(s) | SENS-U Sham-device (placebo) |
| Primary outcome measure | Number of 'wetting accidents' per week measured by questionnaires at baseline and 3 months |
| Secondary outcome measures | 1. Subjective improvement of LUTS according to parents using questionnaires at baseline, 3, and 6 months 2. Change in urinary incontinence during follow-up measured using the number of wetting accidents per week at 6 months 3. Change in frequency voiding chart parameters (average, minimum, maximum void volumes corrected for bladder capacity for age (EBC) measured using voiding charts at baseline, 3, and 6 months 4. Change in Quality of Life measured using questionnaires at baseline, 3, and 6 months 5. Cost-effectiveness measured using questionnaires set out to costs at 6 months 6. Magnitude of the placebo-effect measured using number of wetting accidents per week at baseline and 3 months |
| Overall study start date | 08/06/2021 |
| Completion date | 08/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 15 Years |
| Sex | Both |
| Target number of participants | 480 |
| Key inclusion criteria | 1. Aged between 6 and 15 years 2. Functional daytime urinary incontinence 3. Diagnosed with overactive bladder, dysfunctional voiding, or underactive bladder according to ICCS criteria 4. Eligible for urotherapy |
| Key exclusion criteria | 1. History of congenital urogenital anomalies except for successfully treated mild infravesical obstruction 2. History of neurological underlying disease 3. History of botox treatment for lower urinary tract dysfunction (LUTD) 4. Untreated or treated but persisting functional constipation according to Rome IV criteria <6 months before inclusion 5. Recurrent culture-proven urinary tract infection (UTI) <3 months before inclusion or not controlled by prophylactic antibiotics 6. Previous urotherapy/bladder training <6 months before inclusion 7. Adipositas preventing accurate measurement by the SENS-U as defined as a BMI >95th percentile according to age/gender 8. Skin problems in suprapubic area that are incompatible with the SENS-U adhesive 9. Developmental and itellectual disabilities or severe behavioural and social problems that are incompatible with protocolled urotherapy treatment based on the history and on the opinion of the clinician/urotherapist |
| Date of first enrolment | 01/02/2022 |
| Date of final enrolment | 01/04/2024 |
Locations
Countries of recruitment
- Netherlands
Study participating centres
Nijmegen
6525 GA
Netherlands
Utrecht
3584 EA
Netherlands
Zevenaar
6903 DA
Netherlands
Zwolle
8025 AB
Netherlands
Ede
6716 RP
Netherlands
Sponsor information
Hospital/treatment centre
Geert Grooteplein Zuid 10
Nijmegen
6525
Netherlands
| Phone | +31243611111 |
|---|---|
| Eline.vandewetering@radboudumc.nl | |
| Website | https://www.radboudumc.nl/EN/Pages/default.aspx |
"ROR" |
https://ror.org/05wg1m734 |
Funders
Funder type
Research organisation
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
No information available
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Pseudonymized individual participant data is stored and analyzed in anDREA during the study. At the end of the study, all generated data will be stored in a proprietary format in the DANS EASY repository. In order to reproduce the study findings and to help future users to understand and reuse the data, all changes made to the raw data, including analysis steps will be documented in a data management plan. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 13/08/2022 | 15/08/2022 | Yes | No |
Editorial Notes
20/10/2023: Ziekenhuis Gelderse Vallei was added as a study particiapating centre.
15/08/2022: Publication reference added.
12/01/2022: Trial’s existence confirmed by METC Oost-Nederland.
