Standardization of Lead Placement for Sacral Neuromodulation. Part 1

Universiteit Antwerpen

Status

Unknown

Conditions

Non Obstructive Urinary Retention

Overactive Bladder

Treatments

Diagnostic Test: Pelvic floor EMG

Study type

Interventional

Funder types

Other

Identifiers

NCT03194425

B300201523497 Part 1

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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
Knowledge of planned MRIs, diathermy, or high output ultrasonic exposure
Presence of a documented condition or abnormality that could compromise the safety of the patient
Any psychiatric or personality disorder at the discretion of the study physician
Interstitial cystitis or bladder pain syndrome as defined by the EAU guidelines
Life expectancy of less than 1 year