Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in Home
Phase: NA
Conditions: Overactive Bladder
Sponsor: Theranova, L.L.C.

November 7, 2019 
Page 1 of 2 
CRD-12-1076-01 
Leo-U OAB Aim 2 Clinical Protocol 
Rev A 
 
Title 
Nerve stimulation’s effectiveness at UI frequency in overactive 
patients in home 
NCT# 
NCT03595215 
Objectives 
To demonstrate safety and effectiveness of nerve stimulation using 
the Leo-U TranStim System 
Indications for 
Use/Patient Population 
Leo-U TranStim System is intended for use in patients suffering 
overactive bladder (OAB) and associated symptoms of urinary 
urgency, urinary frequency, and urge incontinence (UI). Subjects will 
receive treatment sessions of Nerve Stimulation each week for 8 
weeks, at home. 
Trial Design 
Single center feasibility, non-randomized, unblinded, Non-Significant 
Risk (NSR) trial. 
Number of Subjects 
11 
Number of Sites 
1 
Inclusion Criteria 
Candidates must meet ALL of the following: 
1. Females 
2. 55-100 years old 
3. Have an average urinary frequency of ≥ 8 voids per 24 hours 
(based on a pre-treatment 3-day voiding “training” diary) 
4. Have self-reported bladder symptoms of more than 3 months 
5. Are ambulatory and able to use the toilet independently 
6. Have been off antimuscarinics, anticholinergics or beta-3 
agonists for at least 2 weeks prior to enrollment OR on a stable 
dose for the prior 3 months 
7. Patient has urinary urge incontinence of ≥ 8 episodes from a 3-
day diary (with incontinence associated at urge level moderate or 
severe) 
8. Able to provide informed consent 
9. Capable and willing to follow all study-related procedures 
Exclusion Criteria 
Candidates cannot meet ANY of the following: 
1. Have primary complaint of stress urinary incontinence 
2. Have a pacemaker or implantable defibrillator 
3. Had botox injections in the bladder or pelvic floor muscles in the 
past 12 months 
4. Have a current urinary tract or vaginal infection 
5. Have an active implantable SNS device (InterStim & Bion) 
6. Have been diagnosed with peripheral neuropathy or nerve 
damage 
7. Currently pregnant 
8. Deemed unsuitable for enrollment in study by the investigator 
based on subjects' history or physical examination 

November 7, 2019 
Page 2 of 2 
CRD-12-1076-01 
Leo-U OAB Aim 2 Clinical Protocol 
Rev A 
Procedures 
1. Subjects will sign the Informed Consent and be screened for 
eligibility in the study. Subjects will receive receive the voiding 
diaries and questionnaires, which will be completed at home. 
2. Subjects will complete “training” voiding diary. 
3. Subjects will complete another 3-day voiding diary and an OAB-q 
to establish a baseline. 
4. Once questionnaires are complete, subjects will visit the site, and 
receive instructions on how to use the TranStim device. 
5. Subjects will bring the TranStim device with them for in-home 
use. For 8 weeks, subjects will self-administer minutes of 
TranStim therapy. The patient will fill out voiding diary and an 
OAB-q at the start of their 5th and 8th week of treatment. 
6. Subjects will return to the clinic at the after their 8th treatment 
week to determine if there are any SAEs or UADEs. Subjects will 
return study related materials to the site during this last visit. 
Endpoints 
Efficacy Endpoints (following Leo-U TranStim therapy): 
1. At least 50% decrease in the number of UI episodes 
compared to pre-treatment 
2. At least 20% decrease in micturitions per day compared to 
pre-treatment 
3. At least 15% improvement in incontinence QoL scores 
compared to pre-treatment 
 
Primary Safety Endpoint 
The incidence and severity of Adverse Events (AEs) including device 
and procedure-related AEs. The incidence and severity of SAEs 
(regardless of relationship to device or procedure). Primary safety 
endpoints will be evaluated at follow-up visit.   
Safety 
Adverse Events (both expected and unexpected) will be recorded 
and reported appropriately throughout the study.  
Sample Size Calculation  This is an open-label feasibility study with the goal of providing proof 
of-principle data for TranStim. Therefore, we will be evaluating the 
results for trends that support further investigation. Nonetheless, by 
having each subject serve as her own control, using a repeated 
measures ANOVA, a sample size of 10 will provide sufficient power 
to detect an effect size of 0.7 (α=0.05, power=0.80). Eleven subjects 
will be enrolled to account for a 10% drop-out rate.