Axonics SacRal NeuromodulaTIon System RegisTRY Study : ARTISTRY
Conditions: Urinary Retention, Urinary Urge Incontinence, Urgency-Frequency, Fecal Incontinence
Sponsor: Axonics, Inc.

Clinical Study Protocol, SNM Male OAB (MOAB) Study 
Axonics Confidential 
Document Number: 105-0076
Rev: B
CLINICAL STUDY PROTOCOL 
Version B: 12 November 2020
 Axonics SNM Registry Study (ARTISTRY)
Protocol Number 105-0076
SPONSOR: 
Axonics, Inc. 
26 Technology Drive, Irvine, CA 92618, USA
CONFIDENTIAL AND PROPRIETATARY DATA: This document and the information contained herein may not 
be reproduced, used, or disclosed without written permission from Axonics, Inc. 

Document Title:  Clinical Trial Protocol, Axonics SNM Registry Study (ARTISTRY) 
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Axonics Confidential 
Document Number: 105-0076 
Rev: B 
1. STUDY SYNOPSIS 
Study Title:   
Axonics SacRal NeuromodulaTIon System RegisTRY study 
(ARTISTRY) 
Study Device:   
Axonics Sacral Neuromodulation System (SNM) System(s).   
 
Study Design:  
Prospective, multi-center, open-label registry study 
Indication for Use: 
The Axonics Sacral Neuromodulation Therapy for urinary control is 
indicated for the treatment of urinary retention (UR) and the 
symptoms of overactive bladder (OAB), including urinary urge 
incontinence (UUI) and significant symptoms of urgency-frequency 
(UF) alone or in combination, in patients who have failed or could 
not tolerate more conservative treatments.  
 
 
Axonics SNM therapy for bowel control is indicated for the 
treatment of chronic fecal incontinence (FI) in patients who have 
failed or are not candidates for more conservative treatments. 
Objective:  
To assess the post-market clinical outcomes with use  of the 
Axonics Sacral Neuromodulation System(s) 
Participants:  
Approximately 300 study participants with the Axonics implantable 
neurostimulator (INS), with the indications for OAB, UR and FI.  
Centers:  
Approximately 30 centers (U.S. and Canada) 
Study Duration: 
The study duration is expected to be approximately 36 months.  
The enrollment phase will be approximately 24 months. 
Participants will participate in the study for 1 year post activation. 
Outcome Measures: 
 
For all indications/patient populations: 
 Patient symptom questionnaire 
 Participant satisfaction with treatment and charging 
questionnaire  
 
Edmonton Frail scale for participants >65 years old 
 Medication usage & Healthcare utilization 
 Device performance metrics 
 Device-Related Adverse Events (AEs) 
 Serious Adverse Events (SAEs) 
 

Document Title:  Clinical Trial Protocol, Axonics SNM Registry Study (ARTISTRY) 
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Axonics Confidential 
Document Number: 105-0076 
Rev: B 
 
  
 
 
For OAB:  
 Quality of life questionnaires (ICIQ-OABqol) 
For UR:  
 AUA Urinary Symptom Index Questionnaire (AUA-
SI) 
For FI:  
 Cleveland Clinic Florida Fecal Incontinence Score 
(CCF-FIS)  
 Fecal Incontinence Quality of Life (FIQL) 
For UF: 
 O’ Leary Sant  
For Constipation:  
 Cleveland Clinic Constipation Score (CCCS) 
 Patient Assessment of Constipation Symptoms 
(PAC-SYM) 
For Sexual Dysfunction: 
 Female Sexual Function Index (FSFI) 
 Sexual health inventory for Men (SHIM) 
For participants that had a prior InterStim System: 
 Conversion questionnaire 
 
Effectiveness outcomes:  
The following effectiveness endpoints are planned in participants 
with the External Trial stimulator (ETS) 
• Trial responder rate – i.e. percentage of Trialed participants 
that were considered responders and received the INS 
implant 
The following indication-specific effectiveness endpoints are 
planned in participants with an ETS or with Axonics lead wire and 
INS (i.e. Full System implant): 
• Therapy responder rate at follow-up i.e. percentage of ETS 
or Full System implant (FS) participants that received at 
least 50% reduction in symptoms as compared to baseline 
and received an INS 
• Change in indication-specific patient symptoms from 
baseline to follow-up  
• Participant satisfaction with therapy and charging  

Document Title:  Clinical Trial Protocol, Axonics SNM Registry Study (ARTISTRY) 
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Document Number: 105-0076 
Rev: B 
• For OAB-UUI and OAB-UF, change in ICIQ-OABqol score at 
follow-up compared to baseline 
• For OAB-UF, change in O’Leary Sant score at follow-up 
compared to baseline 
• For UR, change in AUA-SI score at follow-up compared to 
baseline 
• For FI, change in CCF-FIS and FIQL scores at follow-up 
compared to baseline 
Safety outcomes: 
Rate of Serious Adverse Events (SAEs)  
Rate of device-related AEs, including their seriousness 
Inclusion Criteria: 
1. Patients scheduled to be trialed with the Axonics External Trial 
System (ETS), or patients scheduled to receive an Axonics 
Implantable neurostimulator (INS) or Axonics FS implant 
2. Willing and capable of providing informed consent 
3. Capable of participating in all testing associated with this clinical 
investigation 
Exclusion Criteria: 
 
 
For all indications:  
1. Any significant medical condition that is likely to interfere with 
study procedures, device operation, or likely to confound 
evaluation of study endpoints 
2. Any psychiatric or personality disorder at the discretion of the 
study physician 
3. History of allergic response to titanium, zirconia, polyurethane, 
epoxy, or silicone 
4. A female who is breastfeeding 
5. A female with a positive urine pregnancy test  
 
For OAB & UR:  
6. Current urinary tract mechanical obstruction (e.g. benign prostatic 
enlargement or urethral stricture) 
7. Current symptomatic urinary tract infection (UTI)  
 
          For FI only: 
8. Rectomucosal prolapse or congenital anorectal malformation  
 
 
 

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Document Number: 105-0076 
Rev: B 
Figure 1: Study schematic 
 
 
 
Figure 2: Participant Flowchart 

Document Title:  Clinical Trial Protocol, Axonics SNM Registry Study (ARTISTRY) 
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Document Number: 105-0076 
Rev: B 
Table 1: Study Visit Schedule 
 
Visit schedule & Assessments 
Baseline  
Trial surgery & Activation 
(Day T0) 
Trial Evaluation 
(Day 3-14)*  
(Day 7-28)**  
INS Implant & Activation 
(Day 0) *** 
1-4 Week (s) Visit  
(Day 3-31) 
6-Month Visit  
(Day 160-200) 
1-Year Visit  
(Day 320 - 410) 
Unscheduled Visit 
Informed Consent 
X 
 
 
 
 
 
 
 
Demographics & Medical History 
X 
 
 
 
 
 
 
 
Inclusion/ Exclusion Criteria 
X 
 
 
 
 
 
 
 
Edmonton Frail Scale (EFS) 
(In participants > 65 years old¥) 
 
X 
 
 
 
 
 
 
 
Patient Symptoms Questionnaire 
X 
 
X Ϯ 
 
X 
X 
X 
 
International Consortium for Incontinence Questionnaire 
- Overactive Bladder quality of life (ICIQ-OABqol)  
(In OAB participants only) 
X 
 
 
 
X 
X 
X 
 
AUA Urinary Symptom Index (AUA-SI)  
(In UR participants only) 
X 
 
 
 
X 
X 
X 
 
O’ Leary Sant  
(In UF participants only) § 
X 
 
 
 
X 
X 
X 
 
Cleveland Clinic Florida- Fecal incontinence Score 
(CCF-FIS)§ 
X 
 
 
 
X 
X 
X 
 
Fecal Incontinence Quality of Life (FIQL)Ϫ 
X 
 
 
 
X 
X 
X 
 
Cleveland Clinic Constipation Score (CCCS)§ 
X 
 
 
 
X 
X 
X 
 
Patient Assessment of Constipation Symptoms 
(PAC-SYM) ϪϪ 
X 
 
 
 
X 
X 
X 
 
Sexual Dysfunction questionnatires §§:  
Female Sexual Function Index (FSFI)/  
Sexual Health Inventory for Men (SHIM) 
X 
 
 
 
X 
X 
X 
 
Participant Satisfaction with Treatment and Charging 
questionnaireϮϮ 
 
 
 
 
X 
X 
X 
 
Conversion questionnaire 
 (in participants that had a prior Interstim full system  
and subsequently received an Axonics implant) 
X 
 
 
 
X 
X 
 
 
Medication Usage & Healthcare Utilization 
X 
 
X 
 
X 
X 
X 
X 
Adverse Event Form 
 
X 
X 
X 
X 
X 
X 
X 
Device Performance 
 
X 
 
X 
X 
X 
X 
X 
*For PNE evaluations, ** For Tined lead evaluations, ***Reset to Day 0 at INS Activation ¥ At the time of consent 
Ϯ A question on “time to experience efficacy with Trial” will be asked at this time-point 
§ At baseline, all participants will be administered these questionnaires. At follow-up, these questionnaires will be administered in 
participants that meet the following criteria at baseline: O’Leary Sant will be administered only in participants with baseline score ≥6; CCF-
FIS will only be administered in participants with baseline CCF-FIS score ≥6 or participants that reported as having FI on the Patient 
Symptoms Questionnaire; CCCS will only be administered in participants with baseline CCCS score ≥15.  
Ϫ At baseline and follow-up visits, this questionnaire will be administered only in participants with baseline CCF-FIS score ≥6 or participants 
that reported as having FI on the Patient Symptoms Questionnaire 
ϪϪ At baseline and follow-up visits, this questionnaire will be administered only in participants with baseline CCCS score ≥15 
ϮϮ Charging-related questions from this questionnaire will not be administered at Trial Evaluation and 1-4 Week(s) Visit 
§§ Gender-specific Sexual Dysfunction questionnaires will be administered only in participants who responded being sexually active at the 
time of the study visit. FSFI is a female-specific questionnaire, and SHIM is a male-specific questionnaire.  

Document Title:  Clinical Trial Protocol, Axonics SNM Registry Study (ARTISTRY) 
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Document Number: 105-0076 
Rev: B 
1 
STUDY DESCRIPTION 
 
History/Rationale 
 
The American Urological Association guidance document provides an extensive and systematic literature 
review on the use of SNM for voiding dysfunction1. The guidance states that given the negative effects 
on quality of life associated with severe incontinence and frequency, the panel judged that benefits of 
SNM in the appropriate patients outweigh the risks/burdens.  
 
The Axonics® SNM System (Axonics System) is FDA-approved and indicated for the treatment for bladder 
and bowel symptoms including overactive bladder (OAB), non-obstructive urinary retention (UR) and 
fecal incontinence (FI). As of August 2020, the Axonics System has been commercially implanted in 
approximately 4000 patients2. Additionally, two sponsored clinical studies (RELAX-OAB & ARTISAN-SNM) 
have implanted a total of 180 patients with symptoms of Overactive Bladder (OAB), including UUI, and 
urgency-frequency alone or in combination with UUI.  Long-term results from both of these studies show 
that the Axonics System is safe and effective. Specifically, at 2 years, the ARTISAN-SNM study showed 
93% success rate in patients with UUI2. Similarly, the RELAX-OAB study showed a 90% responder rate in 
OAB patients at 2 years3.  
 
Purpose 
 
The ARTISTRY study is a post-market, clinical study designed to assess the real world clinical outcomes 
with use  of the Axonics Sacral Neuromodulation System(s) for the treatment of the symptoms of OAB,  
UR, and FI.   
 
Safety  
The following types of Adverse Events will be recorded in the ARTISTRY study:  
• Serious Adverse Events (SAEs), regardless of relatedness to the device 
or procedure 
• Device-related AEs  
The definition of Serious Adverse Events is provided in Section 7.5. 
Specifically, the number and participant rates of device-related AEs (including device-related SAEs) will 
be tabulated and reported.  
 
Outcome Measures 
The following metrics will be measured according to the study schedule in Table 1: 
 
 
1 Gormley, E. A., Lightner, D. J., Burgio, K. L., Chai, T. C., Clemens, J. Q., Culkin, D. J., Vasavada, S. P. (2014). Diagnosis and 
treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. Retrieved from 
https://www.auanet.org/common/pdf/education/clinical-guidance/Adult-Urodynamics.pdf. 
2 Company data on file up to end of August 2020 
3 Blok B, Van Kerrebroeck P, de Wachter S, et al. Two-year safety and efficacy outcomes for the treatment of overactive 
bladder using a long-lived rechargeable sacral neuromodulation system. Neurourol Urodyn. 2020;39(4):1108-1114.  

Document Title:  Clinical Trial Protocol, Axonics SNM Registry Study (ARTISTRY) 
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Axonics Confidential 
Document Number: 105-0076 
Rev: B 
For all indications: 
 Patient Symptom Questionnaire 
 Participant satisfaction with treatment and charging questionnaire  
 Edmonton Frail scale for participants >65 years old 
 Medication usage & Healthcare utilization 
 Device performance metrics 
 Device-related Adverse Events (AEs) 
 Serious Adverse Events (SAE) 
For OAB:  
 International Consortium for Incontinence Questionnaire-  Overactive Bladder quality of 
life  (ICIQ-OABqol) 
For UF : 
 O’ Leary Sant score  
For UR:  
 AUA Urinary Symptom Index (AUA-SI) 
For FI:  
 Cleveland Clinic Florida Fecal Incontinence Score (CCF-FIS)  
 Fecal Incontinence Quality of Life (FIQL) 
For Constipation:  
 Cleveland Clinic Constipation Score (CCCS)  
 Patient Assessment of Constipation Symptoms (PAC-SYM) 
For Sexual Dysfunction:  
 Female Sexual Function Index (FSFI) 
 Sexual health Inventory for Men (SHIM) 
 
For participants that had a prior InterStim System: 
 Conversion questionnaire 
 
Study Justification 
The study will be a prospective, multi-center, single-arm, post-market registry study. Participant 
outcomes will be compared to their baseline, with participants serving as their own control.   
The study is anticipated to begin enrollment in the last quarter of 2020 and is expected to complete 
enrollment in approximately 24 months. The study will be conducted at approximately 30 centers in the 
United States and Canada. The scheduled visits are shown in the Study Schematic (Figure 1) and Study 
Visit Schedule (Table 1).  Figure 2 shows the Participant Flowchart throughout the study. Participants will 
be permitted unscheduled visits as needed.