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

Not Applicable

Completed

• Conditions: Urinary Bladder, Overactive
• Interventions: Procedure: Bilateral electrode placement and testing; Procedure: Unilateral electrode placement and testing

• Registration Number: NCT01558856
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Study Timeline

• Study First Submitted: 2012-03-18
• Study First Submitted QC: 2012-03-18
• Study First Posted: 2012-03-20
• Study Start: 2012-10-23
• Primary Completion: 2017-09-20
• Study Completion: 2018-01-23
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Success rate	1 month	"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.

Secondary Outcome Measures

Name	Time	Method
Presence/absence of infection of the implant or electrode	1 month
presence/absence: 50% reduction in the number of urge incontinence episodes per day	1 month
debimetry: urinary volume per voiding	1 month
presence/absence: 50% reduction in the number of daily mictions	1 month
Symptom severity as measured by the MHU score	1 month	MHU = Mesure Hanicap Urinaire
Visual analog scale for pain due to neuro stimulation (pain in legs or buttocks)	1 month
Change in quality of life: IQoL score	baseline to 1 month
presence/absence: 50% reduction in the number of urge incontinence episodes with incontinence per day	1 month
debimetry: flow rate per voiding	1 month
Change in quality of life: SF 36 score	baseline to 1 month
presence/absence: 50% reduction in the number of pads/protections used per day	1 month
Yes/no: the patient was eligible for an implant	1 month
Visual analog scale for pain at the implantation site	1 month
Change in quality of life: KHQ score	baseline to 1 month

Trial Locations

Locations (6)

APHP - Groupe Hospitalier Pitié-Salpetrière; 🇫🇷 Paris Cedex 13, France

CHRU de Toulouse - Hôpital de Rangueil; 🇫🇷 Toulouse Cedex 9, France

Clinique Beau Soleil; 🇫🇷 Montpellier, France

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France

CHU de Rouen - Hôpital Charles Nicolle; 🇫🇷 Rouen, France

CHU de Nantes - Hôtel Dieu; 🇫🇷 Nantes Cedex 1, France