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Tests treatment safety and results for Overactive Bladder (OAB)
Official title Comparative Study of the Efficacy of Treatment of Idiopathic Overactive Bladder (OAB) in Children: Oxybutynine vs. Transcutaneous Neurostimulation
ClinicalTrials.gov ID: NCT07030803
What this study is testing
- What it's testing
- The absence of infectious, urological and neurological causes defines the idiopathic character of overactive bladder (OAB). Although a progressive approach starting with behavioural therapy (urotherapy) is recommended, anticholinergic agents remain the mainstay of medical treatment of overactive bladder (OAB) in children.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 16
You may be able to join if
- Patients aged 6 to 16 years
- Showing signs of OAB (pollakiuria (\> 8 micturitions/d and/or urgenturia(\>x2/week) and/or daytime urine leakage (1/d) and/or nocturia x2/night)
- No treatment for more than 3 months
- Urotherapy rules followed for at least 1 month
- Beneficiary of a social security plan
You likely can't join if
- Neurological cause of bladder dysfunction,
- History of pelvic surgery,
- Significant post-micturition residual (\> 10% of micturition),
- Recurrent urinary tract infections (\> 3) in the 6 months prior to inclusion or urinary tract infection at inclusion.
- Pregnant or breast-feeding adolescents
- Severe constipation resistant to treatment (Rome IV),
See the full eligibility criteria
- Patients aged 6 to 16 years
- Showing signs of OAB (pollakiuria (\> 8 micturitions/d and/or urgenturia(\>x2/week) and/or daytime urine leakage (1/d) and/or nocturia x2/night)
- No treatment for more than 3 months
- Urotherapy rules followed for at least 1 month
- Beneficiary of a social security plan
- Signature of consent by parents/legal guardian(s) and child's agreement
- Neurological cause of bladder dysfunction,
- History of pelvic surgery,
- Significant post-micturition residual (\> 10% of micturition),
- Recurrent urinary tract infections (\> 3) in the 6 months prior to inclusion or urinary tract infection at inclusion.
- Pregnant or breast-feeding adolescents
- Severe constipation resistant to treatment (Rome IV),
- Contraindication to oxybutynin
- Contraindication to the use of TENS (Urostim)
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 16 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.