Standardization of Lead Placement for Sacral Neuromodulation Part 2

Overactive Bladder Clinical Trial

Official title:

Pelvic Floor Electromyography Monitoring as Tool to Improve Patient Selection and Outcome - Standardization of Lead Placement for Sacral Neuromodulation.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03199443
• Other study ID #: B300201523497 Part 2
• Status: Recruiting
• Start date: October 1, 2017
• Est. completion date: August 2022

Study information

• Verified date: October 2019
• Source: Universiteit Antwerpen
• Contact: Stefan De Wachter, MD PhD FEBU
• Phone: +323 821 59 34
• Email: stefan.dewachter[@]uantwerpen.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Non Obstructive Urinary Retention
• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Retention

Intervention

Diagnostic Test:
• EMG pelvic floor
EMG activity during tined lead test procedures will be monitored and the response on needle stimulation will be evaluated

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
Universiteit Antwerpen	Leiden University Medical Center

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EMG pelvic floor	Latency and amplitude measured by probe	1 day
Secondary	Prevalence of adverse events	Prevalence of adverse events, which are defined as: pain, decrease in efficacy and number of reprogramming sessions.	2 years
Secondary	Voiding diary	Determine the success rate of tined lead test period based upon changes in 3 days.	1 year
Secondary	Validated questionnaires (KHQ and PeLFis)	Determine the success rate of tined lead test period based upon changes in validated questionnaires (KHQ and PeLFis).	1 year