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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01558856
First received: March 18, 2012
Last updated: March 4, 2014
Last verified: October 2013
  Purpose

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


Condition Intervention
Urinary Bladder, Overactive
Procedure: Unilateral electrode placement and testing
Procedure: Bilateral electrode placement and testing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial Comparing Unilateral and Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Success rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    "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:
  • presence/absence: 50% reduction in the number of daily mictions [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • presence/absence: 50% reduction in the number of pads/protections used per day [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • presence/absence: 50% reduction in the number of urge incontinence episodes per day [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • presence/absence: 50% reduction in the number of urge incontinence episodes with incontinence per day [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Symptom severity as measured by the MHU score [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    MHU = Mesure Hanicap Urinaire

  • Yes/no: the patient was eligible for an implant [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • debimetry: flow rate per voiding [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • debimetry: urinary volume per voiding [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Visual analog scale for pain at the implantation site [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Visual analog scale for pain due to neuro stimulation (pain in legs or buttocks) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Presence/absence of infection of the implant or electrode [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Change in quality of life: IQoL score [ Time Frame: baseline to 1 month ] [ Designated as safety issue: No ]
  • Change in quality of life: KHQ score [ Time Frame: baseline to 1 month ] [ Designated as safety issue: No ]
  • Change in quality of life: SF 36 score [ Time Frame: baseline to 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Unilateral testing

Following standard procedures, patients in this group will have unilateral testing for neuromodulation of the sacral nerves.

Intervention: Unilateral electrode placement and testing

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.
Experimental: Bilateral testing

Patients in this group will have bilateral testing for neuromodulation of the sacral nerves.

Intervention: Bilateral electrode placement and testing

Procedure: 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558856

Contacts
Contact: Laurent Wagner, MD +33.(0)4.66.68.33.00 laurent.wagner@chu-nimes.fr
Contact: Carey M Suehs, Ph D +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
Clinique Beau Soleil Recruiting
Montpellier, France, 34070
Sub-Investigator: Antoine Faix, MD         
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 09, France, 30029
Principal Investigator: Laurent Wagner, MD         
Sub-Investigator: Stéphane Droupy, MD PhD         
Sub-Investigator: Pierre Costa, MD PhD         
CHRU de Toulouse - Hôpital de Rangueil Recruiting
Toulouse Cedex 9, France, 31059
Sub-Investigator: Xavier Game, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Laurent Wagner, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01558856     History of Changes
Other Study ID Numbers: LOCAL/2011/LW-04, 2012-A00185-38
Study First Received: March 18, 2012
Last Updated: March 4, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
refractory overactive bladder
neuromodulation
sacral nerves

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014