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Standardization of Lead Placement for Sacral Neuromodulation Part 2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03199443
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : October 15, 2019
Leiden University Medical Center
Information provided by (Responsible Party):
Donald Vaganée, Universiteit Antwerpen

Brief Summary:

Prospective observational study.

A substantial number of patients do not respond favourably to sacral neurostimulation (SNS) although clinically, they appear to have the same lower urinary tract (LUT) dysfunction characteristics as the good responders. This may be due to methodological issues (lead position) or patient selection. The purpose of this study is to improve and standardize lead position, in order to increase the patient response to test stimulation and to SNS treatment, and to decrease adverse events.

Condition or disease Intervention/treatment
Overactive Bladder Non Obstructive Urinary Retention Diagnostic Test: EMG pelvic floor

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pelvic Floor Electromyography Monitoring as Tool to Improve Patient Selection and Outcome - Standardization of Lead Placement for Sacral Neuromodulation.
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Group/Cohort Intervention/treatment
Overactive bladder patients Diagnostic Test: EMG pelvic floor
EMG activity during tined lead test procedures will be monitored and the response on needle stimulation will be evaluated

Non Obstructive Urinary Retention patients Diagnostic Test: EMG pelvic floor
EMG activity during tined lead test procedures will be monitored and the response on needle stimulation will be evaluated

Primary Outcome Measures :
  1. EMG pelvic floor [ Time Frame: 1 day ]
    Latency and amplitude measured by probe

Secondary Outcome Measures :
  1. Prevalence of adverse events [ Time Frame: 2 years ]
    Prevalence of adverse events, which are defined as: pain, decrease in efficacy and number of reprogramming sessions.

  2. Voiding diary [ Time Frame: 1 year ]
    Determine the success rate of tined lead test period based upon changes in 3 days.

  3. Validated questionnaires (KHQ and PeLFis) [ Time Frame: 1 year ]
    Determine the success rate of tined lead test period based upon changes in validated questionnaires (KHQ and PeLFis).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with OAB (wet and dry) or non obstructive urinary retention who are therapy resistant to pelvic floor physiotherapy and medical management and wish to undergo a tined lead procedure.

Inclusion Criteria:

  1. Male or female aged ≥18 years and competent to provide consent
  2. Minimum 3 months of self-reported OAB symptoms or self-reported obstructive lower urinary tract symptoms (LUTS) in addition to confirmed non-obstructive urinary retention on urodynamics.
  3. Failed, or are not a candidate for more conservative treatment (i.e., pelvic floor training, biofeedback, behavioral modification, oral pharmacotherapy)
  4. Willing to discontinue OAB medications for 2 weeks prior to the implant and for the entire study period
  5. Able to thoroughly fill in all questionnaires, voiding diaries and office visits for device programming and clinical evaluations before the TLP, 3 weeks after TLP and 6 weeks, 6 months and 1 year after implantation of definitive IPG.

Exclusion Criteria:

  1. Current of prior evidence of primary stress incontinence or mixed incontinence where the stress component overrides the urgency component
  2. Any neurological condition that may interfere with normal bladder function, including stroke, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia)
  3. Urinary tract mechanical obstruction including but not limited to Benign Prostatic Hyperplasia (BPH)
  4. Treatment of bladder or pelvic floor dysfunction with botulinum toxin (Botox ®) or surgery in past 12 months
  5. Unable to toilet self and have and maintain good personal hygiene
  6. Unable to provide clear, thoughtful responses to questions and questionnaires
  7. Urinary tract, bladder or vaginal infection or inflammation
  8. Hematuria, and absence of an elaborate diagnostic work-up
  9. Severe or uncontrolled diabetes (A1C > 8, documented in the last 3 months) or diabetes with peripheral nerve involvement
  10. Allergy to local anesthetic or adhesives
  11. Bleeding disorder or on an anticoagulant that cannot be stopped for 3 days before the implant
  12. Pregnant, lactating, planning to become pregnant, given birth in the past 12 months, or female of child-bearing potential and not practicing a medically-approved method of birth control
  13. Skin lesions or compromised skin at the implant or stimulation site
  14. Use of investigational drug or device therapy or participation in any study involving or impacting gynecologic, urinary or renal function within past 4 weeks
  15. Passive implants (e.g., prostheses) are allowed, but no implanted metal should be at the Neurostimulator implant site
  16. Knowledge of planned magnetic resonance imaging (MRI), diathermy, or high output ultrasonic exposure
  17. Presence of a documented condition or abnormality that could compromise the safety of the patient
  18. Any psychiatric or personality disorder at the discretion of the study physician
  19. Interstitial cystitis or bladder pain syndrome as defined by the guidelines of the European Association of Urology (EAU).
  20. Life expectancy of less than 1 year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03199443

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Contact: Stefan De Wachter, MD PhD FEBU +323 821 59 34 ext +32
Contact: Donald Vaganée +323 821 30 47 ext +32

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Antwerp University Hospital Recruiting
Edegem, Antwerp, Belgium, 2650
Contact: Stefan De Wachter, MD PhD FEBU    +3238215934   
Contact: Donald Vaganée    +3238213047   
Sponsors and Collaborators
Universiteit Antwerpen
Leiden University Medical Center
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Study Director: Stefan De Wachter, MD PhD FEBU University Hospital, Antwerp
Principal Investigator: Donald Vaganée University Hospital, Antwerp

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Responsible Party: Donald Vaganée, Principal Investigator, Universiteit Antwerpen Identifier: NCT03199443     History of Changes
Other Study ID Numbers: B300201523497 Part 2
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Donald Vaganée, Universiteit Antwerpen:
Sacral neuromodulation
Pelvic floor
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Retention
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urination Disorders