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

Urinary Bladder, Overactive Clinical Trial

— HAVIR Bi  

Official title:

Prospective Randomized Trial Comparing Unilateral and Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01558856
• Other study ID #: LOCAL/2011/LW-04
• Secondary ID: 2012-A00185-38
• Status: Completed
• Phase: N/A
• Start date: October 23, 2012
• Est. completion date: January 23, 2018

Study information

• Verified date: August 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: January 23, 2018
• Est. primary completion date: September 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Bladder, Overactive

Intervention

Procedure:
• Unilateral electrode placement and testing
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.
• Bilateral electrode placement and testing
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.

Locations

Country	Name	City	State
France	Clinique Beau Soleil	Montpellier
France	CHU de Nantes - Hôtel Dieu	Nantes Cedex 1
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09
France	APHP - Groupe Hospitalier Pitié-Salpetrière	Paris Cedex 13
France	CHU de Rouen - Hôpital Charles Nicolle	Rouen
France	CHRU de Toulouse - Hôpital de Rangueil	Toulouse Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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