Secondary Bilateral Sacral Nerve Stimulation in Overactive Bladder Patients

NCT01960270 | Completed

• 1 other identifier: 2013/003/HP
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 12

Brief Summary

Unilateral sacral neuromodulation (SNM) has emerged as a valuable treatment for patient with low urinary tract dysfunction when failure or bad tolerance to anticholinergic treatment for overactive bladder. However, in the medium or long term, some patients failed to benefit from unilateral stimulation (unilateral neuromodulation). A contralateral stimulation could be tested then implanted to restore the efficacy. An other option is to perform a bilateral stimulation of the sacral nerves that could lead to a summation effects better than unilateral stimulation. Therefore, if a unilateral sacral nerve stimulation fails, a contralateral or a bilateral test should be considered.

Conditions

Bladder Hyperactivity

Keywords

relapse after an initial clinical response

Outcome Measures

Primary Outcomes (1)

• Success of Test Period

  A successful response is defined as greater than 50% improvement in at least one relevant voiding parameters, with bilateral stimulation versus baseline without stimulation. Relevant voiding diary parameters are: urgency number, frequency, urge incontinence number. These criteria are commonly used in the studies on sacral neuromodulation.

  Day 0

Secondary Outcomes (5)

• Effect of alone controlateral stimulation

  Day 30 and day 60

• Effect of alone controlateral stimulation

  Day 30 and day 60

• Effect of alone controlateral stimulation

  Day 30 and day 60

• Effect of alone controlateral stimulation

  Day 30 and day 60

• Effect of alone controlateral stimulation

  Day 30 and day 60

Study Arms (2)

Alone controlateral stimulation

EXPERIMENTAL

Device: INTERSTIM II * Stimulator II activated * Stimulator I not activated * Measure of efficacy on bladder hyperactivity

Device: Device: INTERSTIM II

2 sides-stimulation

EXPERIMENTAL

Device: INTERSTIM II * Stimulator I and II activated * Measure of efficacy on bladder hyperactivity

Device: Device: INTERSTIM II

Interventions

Device: INTERSTIM II DEVICE

A second stimulator is implanted on controlateral site

2 sides-stimulation; Alone controlateral stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients implanted with Sacral Neuro Modulation for idiopathic OAB with initial efficacy of at least 3 months following by a failure despite optimization of the stimulation (minimum 3)
• OAB evaluated by voiding diary: number of frequency ≥ 8/24 h or urgencies ≥ 3 during 3 days, with or without urge incontinence.
• Age between 18 and 80 years.

You may not qualify if:

• Psychiatric or neurologic disabilities on neurologic evaluation.
• Bladder lithiasis or tumor (cystoscopy or ultrasonography).
• Treatment by drugs that could interfere with the OAB syndromes.
• Pelvic floor exercises should have been interrupted 1 month before.
• No planned surgery on bladder or urinary neurologic tract.
• Diuresis \> 3 liters per 24 hours.
• Negative test at the end of screening period.

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (12)

UH Caen

Caen, France

Location

UH Grenoble

Grenoble, France

Location

GHICL Lille Saint Philibert

Lille, France

Location

Lille University Hospital

Lille, France

Location

Hospices civiles de Lyon

Lyon, France

Location

AP-HM

Marseille, France

Location

UH Nantes

Nantes, France

Location

UH Nîmes

Nîmes, France

Location

AP-HP Pitié Salpetrière

Paris, France

Location

AP-HP Tenon

Paris, France

Location

UH Rouen

Rouen, 76031, France

Location

UH Toulouse

Toulouse, France

Location

Related Publications (3)

• van Kerrebroeck PE, van Voskuilen AC, Heesakkers JP, Lycklama a Nijholt AA, Siegel S, Jonas U, Fowler CJ, Fall M, Gajewski JB, Hassouna MM, Cappellano F, Elhilali MM, Milam DF, Das AK, Dijkema HE, van den Hombergh U. Results of sacral neuromodulation therapy for urinary voiding dysfunction: outcomes of a prospective, worldwide clinical study. J Urol. 2007 Nov;178(5):2029-34. doi: 10.1016/j.juro.2007.07.032. Epub 2007 Sep 17.

  PMID: 17869298 RESULT

• Pham K, Guralnick ML, O'Connor RC. Unilateral versus bilateral stage I neuromodulator lead placement for the treatment of refractory voiding dysfunction. Neurourol Urodyn. 2008;27(8):779-81. doi: 10.1002/nau.20577.

  PMID: 18551562 RESULT

• Marcelissen TA, Leong RK, Serroyen J, van Kerrebroeck PE, De Wachter SG. The use of bilateral sacral nerve stimulation in patients with loss of unilateral treatment efficacy. J Urol. 2011 Mar;185(3):976-80. doi: 10.1016/j.juro.2010.10.065. Epub 2011 Jan 19.

  PMID: 21247601 RESULT

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe GRISE, Pr

  UH Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2013
• First Posted: October 10, 2013
• Study Start: November 12, 2013
• Primary Completion: May 2, 2018
• Study Completion: May 2, 2018
• Last Updated: June 29, 2020

Record last verified: 2020-06

Locations

FR (12)