Condition: Spina Bifida · Sponsor: Central Hospital, Nancy, France
Malformation of the lumbosacral region (spina bifida) affects the innervation of the bladder in children. The usual evolution leads to a neurological bladder with small capacity, poor compliancy and overactivity, exposing to incontinence and obstruction to the evacuation of urine. It is responsible for renal failure requiring dialysis and transplantation. Current therapeutics aim to evacuate urine and reduce intravesical pressure. It gradually combines 1) intermittent catheterization, 2) anticholinergics, 3) botulinum toxin (Botox®) injection into the detrusor (bladder muscle) by cystoscopy and 4) surgery (vesicostomy, Bricker, enterocystoplasty). Oxybutynin relaxes the detrusor, improves continence and reduces intravesical pressure. It is usually administered per os, but there are contraindications (glaucoma, myasthenia), side effects (constipation, dry mouth). It can be difficult to swallow for children, and drug resistance may develop. It can lead to ineffective treatment requiring therapeutic escalation. The next step, intradetrusor Botox® injection, is invasive (cystoscopy), has a limited duration of action (6 months) and must be performed under general anesthesia in children. Surgical treatments are effective but irreversible and responsible for morbidity and mortality. A randomized study was performed demonstrating the efficacy of intravesical oxybutynin compared to oral administration in adult patients. This study found a significant increase in bladder capacity and …
This description comes directly from the study's public registry record.
Nicolas BERTE, Dr · 0383155287 · n.berte@chru-nancy.fr
Jean-Louis LEMELLE, Pr · 0383154729 · jl.lemelle@chru-nancy.fr
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| Centre Hospitalier Universitaire de Besançon | Besançon, France | Not Yet Recruiting |
| Centre Hospitalier Universitaire De Bordeaux | Bordeaux, France | Not Yet Recruiting |
| Centre Hospitalier Régional Et Universitaire De Brest | Brest, France | Not Yet Recruiting |
| Centre Hospitalier Universitaire De Caen Normandie | Caen, France | Not Yet Recruiting |
| Centre Hospitalier Universitaire de Clermont-Ferrand | Clermont-Ferrand, France | Not Yet Recruiting |
| Centre Hospitalier De Colmar | Colmar, France | Not Yet Recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes | Grenoble, France | Not Yet Recruiting |
| Centre Hospitalier Universitaire de Lille | Lille, France | Not Yet Recruiting |
| Centre Hospitalier Et Universitaire De Limoges | Limoges, France | Not Yet Recruiting |
| Centre Hospitalier Régional De Marseille | Marseille, France | Not Yet Recruiting |
| Fondation Lenval Nice | Nice, France | Not Yet Recruiting |
| Hôpital Necker Enfants Malades | Paris, France | Not Yet Recruiting |
+ 7 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07027020