Unilateral Versus Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder (HAVIR Bi)

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Urinary Bladder, Overactive

Treatments: Procedure: Unilateral electrode placement and testing; Procedure: Bilateral electrode placement and testing

Study type: Interventional

Funder types: Other

Identifiers

NCT01558856

2012-A00185-38 (Other Identifier)

LOCAL/2011/PW-04

Details and patient eligibility

About

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

Full description

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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Unilateral testing

Active Comparator group

Description:

Following standard procedures, patients in this group will have unilateral testing for neuromodulation of the sacral nerves. Intervention: Unilateral electrode placement and testing

Treatment:

Procedure: Unilateral electrode placement and testing

Bilateral testing

Experimental group

Description:

Patients in this group will have bilateral testing for neuromodulation of the sacral nerves. Intervention: Bilateral electrode placement and testing

Treatment:

Procedure: Bilateral electrode placement and testing