Standardization of Lead Placement for Sacral Neuromodulation. Part 1

NCT ID: NCT03194425

Last Updated: 2019-10-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2022-08-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

OAB

Patients with overactive bladder on sacral neuromodulation.

Group Type: EXPERIMENTAL

Pelvic floor EMG

Intervention Type: DIAGNOSTIC_TEST

Define pelvic floor EMG template measured by probe

NOUR

Patients with non-obstructive urinary retention on sacral neuromodulation.

Group Type: EXPERIMENTAL

Pelvic floor EMG

Intervention Type: DIAGNOSTIC_TEST

Define pelvic floor EMG template measured by probe

Interventions

Pelvic floor EMG

Define pelvic floor EMG template measured by probe

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

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 MRIs, 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 EAU guidelines

20. Life expectancy of less than 1 year

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Leiden University Medical Center

OTHER

Sponsor Role: collaborator

Universiteit Antwerpen

OTHER

Sponsor Role: lead

Responsible Party

Donald Vaganée

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan De Wachter, MD PhD FEBU

Role: STUDY_DIRECTOR

University Hospital, Antwerp

Donald Vaganée

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

Antwerp University Hospital

Edegem, Antwerp, Belgium

Countries

Belgium

Other Identifiers

B300201523497 Part 1

Identifier Type: -

Identifier Source: org_study_id