Standardization of Lead Placement for Sacral Neuromodulation Part 2

NCT03199443 | Unknown

• 1 other identifier: B300201523497 Part 2
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder; Non Obstructive Urinary Retention

Keywords

Sacral neuromodulation; Electromyography; Pelvic floor

Outcome Measures

Primary Outcomes (1)

• EMG pelvic floor

  Latency and amplitude measured by probe

  1 day

Secondary Outcomes (3)

• Prevalence of adverse events

  2 years

• Voiding diary

  1 year

• Validated questionnaires (KHQ and PeLFis)

  1 year

Study Arms (2)

Overactive bladder patients

Diagnostic Test: EMG pelvic floor

Non Obstructive Urinary Retention patients

Diagnostic Test: EMG pelvic floor

Interventions

EMG pelvic floor DIAGNOSTIC_TEST

EMG activity during tined lead test procedures will be monitored and the response on needle stimulation will be evaluated

Non Obstructive Urinary Retention patients; Overactive bladder patients

Eligibility Criteria

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

You may qualify if:

• Male or female aged ≥18 years and competent to provide consent
• 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.
• Failed, or are not a candidate for more conservative treatment (i.e., pelvic floor training, biofeedback, behavioral modification, oral pharmacotherapy)
• Willing to discontinue OAB medications for 2 weeks prior to the implant and for the entire study period
• 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.

You may not qualify if:

• Current of prior evidence of primary stress incontinence or mixed incontinence where the stress component overrides the urgency component
• 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)
• Urinary tract mechanical obstruction including but not limited to Benign Prostatic Hyperplasia (BPH)
• Treatment of bladder or pelvic floor dysfunction with botulinum toxin (Botox ®) or surgery in past 12 months
• Unable to toilet self and have and maintain good personal hygiene
• Unable to provide clear, thoughtful responses to questions and questionnaires
• Urinary tract, bladder or vaginal infection or inflammation
• Hematuria, and absence of an elaborate diagnostic work-up
• Severe or uncontrolled diabetes (A1C \> 8, documented in the last 3 months) or diabetes with peripheral nerve involvement
• Allergy to local anesthetic or adhesives
• Bleeding disorder or on an anticoagulant that cannot be stopped for 3 days before the implant
• 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
• Skin lesions or compromised skin at the implant or stimulation site
• Use of investigational drug or device therapy or participation in any study involving or impacting gynecologic, urinary or renal function within past 4 weeks
• Passive implants (e.g., prostheses) are allowed, but no implanted metal should be at the Neurostimulator implant site

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• Leiden University Medical Center: collaborator

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

RECRUITING

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

• Stefan De Wachter, MD PhD FEBU

  University Hospital, Antwerp

  STUDY DIRECTOR

• Donald Vaganée

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan De Wachter, MD PhD FEBU

CONTACT

+323 821 59 34; stefan.dewachter@uantwerpen.be

Donald Vaganée

CONTACT

+323 821 30 47; donald.vaganee@uantwerpen.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: June 27, 2017
• Study Start: October 1, 2017
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: October 15, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)