Percutaneous Nerve Evaluation Trial Time

NCT06226220 | Recruiting FDA Device

• 1 other identifier: IRB23-0942
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 1

Brief Summary

Sacral neuromodulation (SNM) was approved by the Food and Drug Administration (FDA) for the treatment of urgency incontinence (UUI) in 1998. One of two trial phase techniques are utilized prior to placement of the implantable pulse generator (IPG) to predict a patient's success with the device: a percutaneous nerve evaluation (PNE) or a stage implantation. Patients who experience a \> 50% improvement in UUI symptoms progress to permanent implantation. PNE offers significant advantages compared to a staged implantation including a single anesthetic and operating room trip. Historically, full implantation rates are only 40-50% following PNE versus 70-90% in women who undergo a staged approach. The lower rate of progression to full implantation after PNE may be attributed to lead migration. Newer data suggest up to 90% of PNE trials lead to full implantation. The investigators hypothesize that shortening PNE trial time to 3 days from 7 days will not result in a lower proportion of PNE trials leading to SNM implantation and may offer less time for lead migration. The investigators aim to perform a multi-center, randomized trial to determine if a 3-day PNE trial is not inferior to a 7-day PNE trial with respect to rates of progression to SNM implantation.

Conditions

Urge Incontinence; Urgency-frequency Syndrome; Overactive Bladder

Keywords

urinary urgency; urinary incontinence; urinary frequency; overactive bladder; sacral neuromodulation; percutaneous nerve evaluation

Outcome Measures

Primary Outcomes (1)

• Rate of progression onto full sacral neuomodulation (SNM) implant

  Participants with an adequate therapeutic response during percutaneous nerve evaluation (PNE) trial (\>/=50% improvement in urgency urinary incontinence (UUI)/ urgency-frequency (UF) symptoms) will progress onto full SNM implantation

  3 or 7 days depending on treatment arm

Secondary Outcomes (3)

• Patient satisfaction

  3 or 7 days depending on treatment arm

• Rate of adverse events

  3 or 7 days depending on treatment arm

• Quality of life scores

  3 or 7 days depending on treatment arm

Study Arms (2)

3-day trial

EXPERIMENTAL

Patients randomized to the 3-day trial arm will undergo a 3-day PNE trial phase for sacral neuromodulation. Participants will have the PNE placed in the office and return on day 3 for PNE removal.

Procedure: Sacral neuromodulation

7-day trial

ACTIVE COMPARATOR

Patients randomized to the73-day trial arm will undergo a 7-day PNE trial time for sacral neuromodulation. Participants will have the PNE placed in the office and return on day 7 for PNE removal.

Procedure: Sacral neuromodulation

Interventions

Sacral neuromodulation PROCEDURE

Sacral neuromodulation (SNM) is a minimally invasive procedure that provides low-amplitude electrical stimulation to the S3 nerve root to improve micturition and defecation. Patients who elect to proceed with SNM undergo a trial phase to determine therapeutic response prior to placement of a permanent implantable pulse generator (IPG). A trial phase can be performed in two ways: a percutaneous nerve evaluation (PNE) or staged implantation. PNE involves the placement of a temporary wire connected to an electrode using external stimulation. It is performed in the office using local anesthesia. If the patient displays adequate improvement in symptoms (defined as \>50% improvement of symptoms from baseline), a permanent lead and subcutaneous IPG are implanted in the operating room.

Also known as: Percutaneous nerve evaluation

3-day trial; 7-day trial

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-pregnant women \>/=18 years old undergoing sacral neuromodulation (SNM) treatment for urgency urinary incontinence (UUI) or urgency-frequency (UF) who have elected to undergo testing phase with a PNE
• \>/=5 UUI episodes on a 3-day bladder diary with urge incontinence representing \>/=50% of total incontinence episodes recorded or \>/=8 per day for 2 days on a 3-day bladder diary
• Willing and able to complete all study related items and interviews
• Grossly neurologically normal exam

You may not qualify if:

• SNM indication of non-obstructive urinary retention or isolated fecal incontinence
• Severe or poorly controlled diabetes (defined as HgbA1c \>/=8.0) or diabetes with peripheral nerve involvement
• Neurological diseases such as multiple sclerosis, clinically significant peripheral neuropathy, or complete spinal cord injury
• Surgically altered detrusor muscle (i.e. Augmentation cystoplasty)
• Current or prior bladder malignancy
• Prior pelvic irradiation
• Post void residual (PVR) \>/= 150 mL within 6 months prior to enrollment
• Active urinary tract infection
• Primary stress urinary incontinence or mixed urinary incontinence with stress predominance
• \>/= Stage III pelvic organ or vaginal vault prolapse and/or current pessary use

Sponsors & Collaborators

• University of Chicago: lead
• University of California, Irvine: collaborator
• Atrium Health Wake Forest Baptist: collaborator
• University of Texas: collaborator
• Brown University: collaborator
• Allegheny Health Network: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Related Publications (14)

• Siegel S, Noblett K, Mangel J, Griebling TL, Sutherland SE, Bird ET, Comiter C, Culkin D, Bennett J, Zylstra S, Berg KC, Kan F, Irwin CP. Results of a prospective, randomized, multicenter study evaluating sacral neuromodulation with InterStim therapy compared to standard medical therapy at 6-months in subjects with mild symptoms of overactive bladder. Neurourol Urodyn. 2015 Mar;34(3):224-30. doi: 10.1002/nau.22544. Epub 2014 Jan 10.

  PMID: 24415559 BACKGROUND

• Amundsen CL, Komesu YM, Chermansky C, Gregory WT, Myers DL, Honeycutt EF, Vasavada SP, Nguyen JN, Wilson TS, Harvie HS, Wallace D; Pelvic Floor Disorders Network. Two-Year Outcomes of Sacral Neuromodulation Versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: A Randomized Trial. Eur Urol. 2018 Jul;74(1):66-73. doi: 10.1016/j.eururo.2018.02.011. Epub 2018 Feb 24.

  PMID: 29482936 BACKGROUND

• Bannowsky A, Wefer B, Braun PM, Junemann KP. Urodynamic changes and response rates in patients treated with permanent electrodes compared to conventional wire electrodes in the peripheral nerve evaluation test. World J Urol. 2008 Dec;26(6):623-6. doi: 10.1007/s00345-008-0307-7. Epub 2008 Jul 16.

  PMID: 18629503 BACKGROUND

• Hijaz A, Vasavada SP, Daneshgari F, Frinjari H, Goldman H, Rackley R. Complications and troubleshooting of two-stage sacral neuromodulation therapy: a single-institution experience. Urology. 2006 Sep;68(3):533-7. doi: 10.1016/j.urology.2006.03.020. Epub 2006 Sep 18.

  PMID: 16979724 BACKGROUND

• Blandon RE, Gebhart JB, Lightner DJ, Klingele CJ. Re-operation rates after permanent sacral nerve stimulation for refractory voiding dysfunction in women. BJU Int. 2008 May;101(9):1119-23. doi: 10.1111/j.1464-410X.2007.07426.x. Epub 2008 Jan 10.

  PMID: 18190624 BACKGROUND

• Borawski KM, Foster RT, Webster GD, Amundsen CL. Predicting implantation with a neuromodulator using two different test stimulation techniques: A prospective randomized study in urge incontinent women. Neurourol Urodyn. 2007;26(1):14-8. doi: 10.1002/nau.20332.

  PMID: 17123297 BACKGROUND

• Spinelli M, Weil E, Ostardo E, Del Popolo G, Ruiz-Cerda JL, Kiss G, Heesakkers J. New tined lead electrode in sacral neuromodulation: experience from a multicentre European study. World J Urol. 2005 Jul;23(3):225-9. doi: 10.1007/s00345-005-0502-8. Epub 2005 Jun 30.

  PMID: 15988594 BACKGROUND

• Siegel SW, Catanzaro F, Dijkema HE, Elhilali MM, Fowler CJ, Gajewski JB, Hassouna MM, Janknegt RA, Jonas U, van Kerrebroeck PE, Lycklama a Nijeholt AA, Oleson KA, Schmidt RA. Long-term results of a multicenter study on sacral nerve stimulation for treatment of urinary urge incontinence, urgency-frequency, and retention. Urology. 2000 Dec 4;56(6 Suppl 1):87-91. doi: 10.1016/s0090-4295(00)00597-5.

  PMID: 11114569 BACKGROUND

• Al-zahrani AA, Elzayat EA, Gajewski JB. Long-term outcome and surgical interventions after sacral neuromodulation implant for lower urinary tract symptoms: 14-year experience at 1 center. J Urol. 2011 Mar;185(3):981-6. doi: 10.1016/j.juro.2010.10.054. Epub 2011 Jan 19.

  PMID: 21247597 BACKGROUND

• Goldman HB, Lloyd JC, Noblett KL, Carey MP, Castano Botero JC, Gajewski JB, Lehur PA, Hassouna MM, Matzel KE, Paquette IM, de Wachter S, Ehlert MJ, Chartier-Kastler E, Siegel SW. International Continence Society best practice statement for use of sacral neuromodulation. Neurourol Urodyn. 2018 Jun;37(5):1823-1848. doi: 10.1002/nau.23515. Epub 2018 Apr 11.

  PMID: 29641846 BACKGROUND

• Banakhar M, Hassouna M. Percutaneous Nerve Evaluation Test Versus Staged Test Trials for Sacral Neuromodulation: Sensitivity, Specificity, and Predictive Values of Each Technique. Int Neurourol J. 2016 Sep;20(3):250-254. doi: 10.5213/inj.1630498.249. Epub 2016 Sep 23.

  PMID: 27706006 BACKGROUND

• Amundsen CL, Romero AA, Jamison MG, Webster GD. Sacral neuromodulation for intractable urge incontinence: are there factors associated with cure? Urology. 2005 Oct;66(4):746-50. doi: 10.1016/j.urology.2005.04.031.

  PMID: 16230129 BACKGROUND

• White WM, Mobley JD 3rd, Doggweiler R, Dobmeyer-Dittrich C, Klein FA. Sacral nerve stimulation for refractory overactive bladder in the elderly population. J Urol. 2009 Oct;182(4):1449-52. doi: 10.1016/j.juro.2009.06.049. Epub 2009 Aug 15.

  PMID: 19683295 BACKGROUND

• Elterman DS, Chughtai B, Vertosick E, Thomas D, Eastham J, Sandhu J. Trends and Clinical Practice Patterns of Sacral Neuromodulation for Overactive Bladder. Female Pelvic Med Reconstr Surg. 2018 Jul/Aug;24(4):264-266. doi: 10.1097/SPV.0000000000000449.

  PMID: 28658001 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Urge; Urinary Bladder, Overactive; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; 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; Urinary Bladder Diseases

Study Officials

• Kimberly Kenton, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah L Ashmore, MD

CONTACT

9705811554; sashmore@uchicagomedicine.org

Rowena Shi

CONTACT

jinxuanshi@uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-center, randomized, non-inferiority trial

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 26, 2024
• Study Start: December 10, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)