Onabotulinumtoxina Intradetrusorial Injections and NGF Expression (Onab/A-NGF)
|ClinicalTrials.gov Identifier: NCT01629433|
Recruitment Status : Completed
First Posted : June 27, 2012
Last Update Posted : June 27, 2012
|Condition or disease||Phase|
|Overactive Detrusor Detrusor Hyperreflexia of Bladder||Phase 4|
|Study Type :||Observational|
|Actual Enrollment :||25 participants|
|Official Title:||PHASE IV STUDY ON THE EFFECTS OF ONABOTULINUMTOXINA INTRADETRUSORIAL INJECTIONS ON BLADDER EXPRESSION OF NGF, TRKA, P75 AND TRPV1 IN PATIENTS WITH DETRUSOR OVERACTIVITY|
|Study Start Date :||January 2009|
|Primary Completion Date :||June 2011|
|Study Completion Date :||March 2012|
botulinum A toxin
18 patients with neurogenic DO and 7 with idiopathic DO All the patients had overactive bladder (OAB) symptoms and DO refractory to conventional anticholinergics.
- to investigate onab/A- induced changes on gene expression of NGF, TRPV1, TrkA and p75 in bladder wall tissue of patients with neurogenic and idiopathic DO.All patients underwent cystoscopy with bladder wall biopsy specimens. After undergoing cystoscopy with bladder sampling patients underwent onab/A intradetrusorial injections. Patients were injected with 100 or 300 onab/A U according to the type of DO. Urodynamic studies and cystoscopies with bladder sampling were repeated 1 month later. NGF and neuroreceptors (TrkA, TRPV1, p75)gene expression have been measured with Real Time Polymerase Chain reaction. NGF bladder tissue content (protein) has been added into evaluation and measured with ELISA.
- To evaluate urodynamic improvementsImprovement in uninhibited detrusor contractions' maximum pressure (cmh20).
- To investigate urodynamic improvements.Improvement in uninhibited detrusor contractions' first volume (ml)
- To investigate urodynamic improvements.Improvement in maximum cystometric capacity (ml).
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01629433
|University of Perugia, Dept. of Urology and Andrology|
|Perugia, Italy, 06100|