Experiences and quality of life in children and their parents treated with nerve stimulation for urinary incontinence
| ISRCTN | ISRCTN68115364 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68115364 |
| Secondary identifying numbers | METC Arnhem-Nijmegen 2021-13133 |
- Submission date
- 26/06/2022
- Registration date
- 27/06/2022
- Last edited
- 05/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
Posterior tibial nerve stimulation (PTNS) is one of the treatment modalities for children with lower urinary tract dysfunction (LUTD).
Lower Urinary Tract Dysfunction, also known as dysfunctional voiding, is a condition that affects many children and is generally not a serious problem but is certainly a nuisance. Dysfunctional voiding is generally felt to be a dis-coordination between the bladder and the bladder outlet.
This study is a mixed-methods analysis to gain insight into the experiences of children treated with PTNS and their parents, the effect of treatment on Quality of Life (QOL) and effect of PTNS on urinary symptoms.
Who can participate?
Children with lower urinary tract dysfunction receiving posterior tibial nerve stimulation (PTNS) treatment and their parents
What does the study involve?
A single-center retrospective chart analysis of all children between 6-12 years of age with LUTD treated with PTNS in a group setting between 2016-2021. Voiding parameters and QOL scores before and after treatment are compared. Qualitative outcomes are assessed by an explorative study involving semi-structured interviews transcribed verbatim and inductively analysed using the constant comparative method. Interviews are done between October 2021-December 2021.
What are the possible benefits and risks of participating?
There are no risks or direct potential benefits for participants. Potential burden for the individual subjects is mainly time consummation of 45 minutes.
Where is the study run from?
Radboud University Medical Center, Amalia Children's Hospital (the Netherlands)
When is the study starting and how long is it expected to run for?
September 2021 to December 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Liesbeth de Wall, liesbeth.dewall@radboudumc.nl
Contact information
Principal Investigator
Geert grooteplein zuid 10
Nijmegen
6500HB
Netherlands
 ORCID ID |
0000-0002-1704-6772 |
|---|---|
| Phone | +31-24-3613735 |
| liesbeth.dewall@radboudumc.nl |
Study information
| Study design | Mixed methods study (quantitative and qualitative analysis). Retrospective chart analysis (quantitative) and explorative qualitative study with semi-structured interviews |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Experiences with posterior tibial nerve stimulation in children and their parents, Quality of life and effect on lower urinary tract dysfunction. A mixed methods analysis. |
| Study acronym | PTNS and QOL |
| Study hypothesis | How do parents and children experience PTNS? How does PTNS treatment effect Quality of life in children with urinary symptoms and their parents? How does QOL change during treatment? What is the outcome of PTNS on urinary symptoms? We hypothesize an improvement of both OQL and urinary symptoms after treatment with PTNS. |
| Ethics approval(s) | Approved 02/09/2021, Medical Ethics Committee METC Arnhem-Nijmegen (Nijmegen, the Netherlands; METCoost-en-CMO@radboudumc.nl; +31-243613154), ref: 2021-13133 |
| Condition | Quality of life and experiences with neuromodulation in children with lower urinary tract dysfunction |
| Intervention | Quantitative outcomes were assessed trough a single-center retrospective chart analysis of all children treated with PTNS in a group setting between 2016-2021. Voiding parameters and QOL scores before and after treatment were compared. Qualitative outcomes were assessed by an explorative study involving semi-structured interviews transcribed verbatim and inductively analysed using the constant comparative method. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Experiences of children and their parents assessed by an explorative study involving semi-structured interviews transcribed verbatim and inductively analysed using the constant comparative method. |
| Secondary outcome measures | Measured using patient records at a single time point (retrospective analysis): 1. Change in QOL before and after treatment 2. Effect of PTNS on urinary symptoms 3. Change in maximum and average voided volume throughout treatment |
| Overall study start date | 02/09/2021 |
| Overall study end date | 28/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 101 |
| Total final enrolment | 101 |
| Participant inclusion criteria | Children with lower urinary tract dysfunction receiving posterior tibial nerve stimulation (PTNS) treatment and their parents |
| Participant exclusion criteria | 1. Children not receiving PTNS 2. Children and or parents not willing to participate in the interviews |
| Recruitment start date | 01/10/2021 |
| Recruitment end date | 15/12/2021 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Nijmegen
6500HB
Netherlands
Sponsor information
Hospital/treatment centre
Amalia Children's Hospital
Geert Grooteplein zuid 10
Nijmegen
6500HB
Netherlands
| Phone | +31-24-3613735 |
|---|---|
| Anke.oerlemans@radboudumc.nl | |
| Website | https://www.radboudumc.nl/EN/Pages/default.aspx |
"ROR" |
https://ror.org/05wg1m734 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in journal: international journal of Environmental Research and Health |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request: Dr.LL de Wall, liesbeth.dewall@radboudumc.nl. This include anonymised data of participants, SPSS data and transcribed data in Atlas.ti. Data are available after publication and after a data transfer agreement and for academic purposes only. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1 | 01/08/2021 | 27/06/2022 | No | No |
| Results article | 25/07/2022 | 05/12/2022 | Yes | No |
Additional files
Editorial Notes
05/12/2022: Publication reference added.
27/06/2022: Trial's existence confirmed by Medical Ethics Committee METC Arnhem-Nijmegen
