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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01558856
• Date of registration: 18/03/2012
• Prospective Registration: Yes
• Primary sponsor: Centre Hospitalier Universitaire de Nimes
• Public title: Unilateral Versus Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder HAVIR Bi
• Scientific title: Prospective Randomized Trial Comparing Unilateral and Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder
• Date of first enrolment: October 23, 2012
• Target sample size: 55
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01558856
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Laurent Wagner, MD
• Affiliation: Centre Hospitalier Universitaire de Nîmes

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Urinary Bladder, Overactive

Intervention(s)

Procedure: Bilateral electrode placement and testing

Procedure: Unilateral electrode placement and testing

Primary Outcome(s)

Success rate [Time Frame: 1 month]

Secondary Outcome(s)

Change in quality of life: IQoL score [Time Frame: baseline to 1 month]

Change in quality of life: KHQ score [Time Frame: baseline to 1 month]

presence/absence: 50% reduction in the number of urge incontinence episodes per day [Time Frame: 1 month]

Visual analog scale for pain at the implantation site [Time Frame: 1 month]

debimetry: urinary volume per voiding [Time Frame: 1 month]

presence/absence: 50% reduction in the number of pads/protections used per day [Time Frame: 1 month]

presence/absence: 50% reduction in the number of urge incontinence episodes with incontinence per day [Time Frame: 1 month]

debimetry: flow rate per voiding [Time Frame: 1 month]

Yes/no: the patient was eligible for an implant [Time Frame: 1 month]

Change in quality of life: SF 36 score [Time Frame: baseline to 1 month]

Visual analog scale for pain due to neuro stimulation (pain in legs or buttocks) [Time Frame: 1 month]

Presence/absence of infection of the implant or electrode [Time Frame: 1 month]

presence/absence: 50% reduction in the number of daily mictions [Time Frame: 1 month]

Symptom severity as measured by the MHU score [Time Frame: 1 month]

Secondary ID(s)

LOCAL/2011/LW-04

2012-A00185-38

Source(s) of Monetary Support

Please refer to primary and secondary sponsors