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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
An electrode is placed near a sacral nerve with an anal motor response under general anesthesia. During and adjustment phase, the electode is connected to a test box which allows for adjustment of stimulation parameters. After pinpointing stimulation parameters, the external test box is replaced by an implanted device.
Two electrodes are placed, one near each sacral nerve under general anesthesia. During an adjustment phase, the electodes are connected to a test box which allows for adjustment of stimulation parameters. This can result in the use of one or the other, or both electrodes, thus increasing the chances of success and the possibility that the patient is eligible for an implant. After pinpointing stimulation parameters, the external test box is replaced by an implanted device.
Clinique Beau Soleil
Montpellier, France
CHU de Nantes - Hôtel Dieu
Nantes, France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France
APHP - Groupe Hospitalier Pitié-Salpetrière
Paris, France
Success rate
"Success" is defined as a \>= 50% improvement in at least one of the following symtoms: pollakiuria, number of urge incontinence episodes with incontinence, number of urge incontinence episodes.
Time frame: 1 month
presence/absence: 50% reduction in the number of daily mictions
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 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
Symptom severity as measured by the MHU score
MHU = Mesure Hanicap Urinaire
Time frame: 1 month
Yes/no: the patient was eligible for an implant
Time frame: 1 month
debimetry: flow rate per voiding
Time frame: 1 month
debimetry: urinary volume per voiding
Time frame: 1 month
Visual analog scale for pain at the implantation site
Time frame: 1 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CHU de Rouen - Hôpital Charles Nicolle
Rouen, France
CHRU de Toulouse - Hôpital de Rangueil
Toulouse, France
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
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
Change in quality of life: SF 36 score
Time frame: baseline to 1 month