Standardization of Lead Placement for Sacral Neuromodulation. Part 1

NCT03194425 | Unknown

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

Brief Summary

Retrospective case-control 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 dysfunction characteristics as the ones with good responses. 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 activity of pelvic floor muscles in OAB patients and NOUR patients already on SNM

  Latency and amplitude of pelvic floor measured by EMG probe

  1 day

Study Arms (2)

OAB

EXPERIMENTAL

Patients with overactive bladder on sacral neuromodulation.

Diagnostic Test: Pelvic floor EMG

NOUR

EXPERIMENTAL

Patients with non-obstructive urinary retention on sacral neuromodulation.

Diagnostic Test: Pelvic floor EMG

Interventions

Pelvic floor EMG DIAGNOSTIC_TEST

Define pelvic floor EMG template measured by probe

NOUR; OAB

Eligibility Criteria

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

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 LUTS in addition to confirmed non-obstructive urinary retention on UDO
• 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

Location

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: June 21, 2017
• Study Start: September 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)