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

Centre Hospitalier Universitaire de Nīmes6 sites in 1 country55 target enrollmentOctober 23, 2012

ConditionsUrinary Bladder, Overactive

Overview

Phase: N/A
Intervention: Not specified
Conditions: Urinary Bladder, Overactive
Sponsor: Centre Hospitalier Universitaire de Nīmes
Enrollment: 55
Locations: 6
Primary Endpoint: Success rate
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 23, 2012

End Date

January 23, 2018

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Nīmes

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Success rate

Time Frame: 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 Outcomes

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)
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)