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Effectiveness of a Peroneal Stimulation Treatment for Children with Overactive Bladder

Effectiveness of Peroneal Electrical Transcutaneous Neuromodulation (Peroneal eTNM®) in Children with Overactive Bladder: A Prospective Cohort Study - Effectiveness and Long-term Outcomes of Peroneal Electrical Transcutaneous Neuromodulation in Children with Overactive Bladder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON58218
Enrollment
34
Registered
2025-02-19
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder Syndrome (OAB) Overactive bladder

Interventions

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Children aged 6 to 16 years with a diagnosed OABWillingness to complete the entire follow-up period

Exclusion criteria

Exclusion criteria: Neurological conditionsCongenital urinary tract abnormalitiesPrevious neuromodulation within the past 3 monthsPrevious medication treatment within the past 2 weeksActive pelvic floor physiotherapy treatmentPost void residu > 35% of voided volumeMore than 2 proven UTI’s in the last 2 months

Design outcomes

Primary

MeasureTime frame
The primary study parameter is the change in voiding frequency, as documented in a two-day voiding diary, before and after six weeks of peroneal eTNM, and after 12 weeks of follow-up.

Secondary

MeasureTime frame
One of the secondary objectives is to evaluate the change in voiding frequency, as recorded in a two-day voiding diary, after the 12-week follow-up period in comparison to baseline and post-intervention (week 6). The other secondary objectives are to evaluate treatment-related side effects and patient satisfaction, Vancouver Symptom Score for Dysfunctional Elimination Syndrome (VSSDES scores), changes in Pediatric Urinary Incontinence Quality of Life (PinQ) scores, Bristol Stool Chart (BSC) and alterations in the frequency of urgency episodes, urinary incontinence episodes, and nocturnal incontinence.

Countries

Netherlands

Contacts

Public ContactJ. de Klerk

Erasmus MC, Universitair Medisch Centrum Rotterdam

j.deklerk.1@erasmusmc.nl+31636532575

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)