Unilateral Versus Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder

Prospective Randomized Trial Comparing Unilateral and Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder

The primary objective of this study is to compare the efficacy of unilateral and bilateral neuromodulation tests at 1 month.

The secondary objectives of this study are to compare the following elements between a group of patients undergoing unilater modulation tests (standard procedure) and a group of patients undergoing bilateral neuromodulation tests (experimental procedure) (at 1 month): Pollakiuria, pad use, urge incontinence, symptom severity, % of patients not eligible for an implant, debimetry, tolerance, complications, quality of life.

Inclusion Criteria:

• The patient must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient is available for 1 month of follow-up
• The patient understands and reads French
• The patient has symptoms of overactive bladder resistant to first-line treatments (physiotherapy, anticholinergics)
• The patient suffers from an overactive bladder confirmed by a urodynamic panel
• The patient suffers from an overactive bladder unassociated with bladder obstruction as confirmed by flowmetry
• The patient has primary (idiopathic) overactive bladder primary with normal urinalysis, abdominal and pelvic ultrasound, urine cytology + / - cystoscopy
• The patient has no bleeding disorders, or the disorder is properly controlled after treatment

Exclusion Criteria:

• The patient is participating in another study
• The patient is in an exclusion period determined by a previous study
• The patient is under judicial protection, under tutorship or curatorship
• The patient refuses to sign the consent
• It is impossible to correctly inform the patient
• The patient is pregnant, parturient, or breastfeeding
• Overactive bladder associated with bladder obstruction as determined by flowmetry
• Overactive bladder unconfirmed by urodynamic panel
• Overactive bladder secondary to another condition:
• vesical: urolithiasis, bladder polyp, interstitial cystitis
• pelivienne: tumor or inflammatory
• neurological: multiple sclerosis, brain tumor, epilepsy
• the patient has an uncorrectable bleeding disorder