Clinical trial NCT01558856: Unilateral Versus Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder
Official title: Prospective Randomized Trial Comparing Unilateral and Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Bladder, Overactive
Keywords: refractory overactive bladder
neuromodulation
sacral nerves
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-03-20
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Success rate
timeFrame: 1 month
Secondary outcomes:
measure: presence/absence: 50% reduction in the number of daily mictions
timeFrame: 1 month
measure: presence/absence: 50% reduction in the number of pads/protections used per day
timeFrame: 1 month
measure: presence/absence: 50% reduction in the number of urge incontinence episodes per day
timeFrame: 1 month
measure: presence/absence: 50% reduction in the number of urge incontinence episodes with incontinence per day
timeFrame: 1 month
measure: Symptom severity as measured by the MHU score
timeFrame: 1 month
measure: Yes/no: the patient was eligible for an implant
timeFrame: 1 month
measure: debimetry: flow rate per voiding
timeFrame: 1 month
measure: debimetry: urinary volume per voiding
timeFrame: 1 month
measure: Visual analog scale for pain at the implantation site
timeFrame: 1 month
measure: Visual analog scale for pain due to neuro stimulation (pain in legs or buttocks)
timeFrame: 1 month
measure: Presence/absence of infection of the implant or electrode
timeFrame: 1 month
measure: Change in quality of life: IQoL score
timeFrame: baseline to 1 month
measure: Change in quality of life: KHQ score
timeFrame: baseline to 1 month
measure: Change in quality of life: SF 36 score
timeFrame: baseline to 1 month
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Clinique Beau Soleil
city: Nantes Cedex 1
country: France
facility: CHU de Nantes - Hôtel Dieu
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
city: Paris Cedex 13
country: France
facility: APHP - Groupe Hospitalier Pitié-Salpetrière
city: Rouen
country: France
facility: CHU de Rouen - Hôpital Charles Nicolle
city: Toulouse Cedex 9
country: France
facility: CHRU de Toulouse - Hôpital de Rangueil
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Laurent Wagner, MD
role: PRINCIPAL_INVESTIGATOR
References: