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Trial registered on ANZCTR


Registration number
ACTRN12618001582246
Ethics application status
Approved
Date submitted
24/05/2018
Date registered
24/09/2018
Date last updated
1/02/2019
Date data sharing statement initially provided
1/02/2019
Date results information initially provided
1/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of stimulation on overactive bladder patients
Scientific title
A prospective feasibility study evaluating the implantation procedure and stimulation effects of tibial and/or saphenous nerve stimulation on patients with overactive bladder (OAB)
Secondary ID [1] 294989 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overactive bladder 308004 0
Condition category
Condition code
Renal and Urogenital 307039 307039 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undergo implantation of a neurostimulator lead under the skin of the lower leg, and randomised 2:1 to determine electrode position facing either the tibial nerve or subcutaneous tissue (saphenous nerve). An external peripheral nerve stimulator will be attached to the lead and stimulation testing will be conducted to optimise individual participant stimulation parameters as determined by the physician to deliver 2 hours of stimulation daily for 5 days, with an optional additional stimulation period of 10 days. The external peripheral nerve stimulator and lead will be dressed in a waterproof dressing and instructions provided to the patient on care for the dressing, with weekly visit to the site for a dressing change. Stimulation compliance will be monitored through neurostimulator analytics. The lead will be removed following the last day of stimulation.
Intervention code [1] 301324 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Active

Outcomes
Primary outcome [1] 306018 0
Paresthesia coverage map as reported by participant
Timepoint [1] 306018 0
Assessed at day 5 for the previous 5 days
Primary outcome [2] 306019 0
Paresthesia quality questionnaire scale designed specifically for the study
Timepoint [2] 306019 0
Assessed at day 5 for the previous 5 days
Primary outcome [3] 306020 0
Incontinence symptoms:through 3 day Voiding Diary to assess feasibility
Timepoint [3] 306020 0
Days 2-4
Secondary outcome [1] 347342 0
Incontinence quality of life (I-QOL Questionnaire)
Timepoint [1] 347342 0
Day 5
Secondary outcome [2] 347343 0
Bladder symptom Questionnaire (OAB-q)
Timepoint [2] 347343 0
Day 5
Secondary outcome [3] 347441 0
Incidence, severity & relatedness of all Adverse Events as reported by patients to the Investigator and medical records review by Investigator to assess study procedure feasibility
Timepoint [3] 347441 0
Day 19 (or Day 29 with optional additional 10 day stimulation)
Secondary outcome [4] 352111 0
Successful placement to lead as confirmed by EMG (Electromyography) to assess procedure feasibility
Timepoint [4] 352111 0
Implantation

Eligibility
Key inclusion criteria
1. Males and females who are 18-75 years of age at the time of enrollment
2. Be willing and capable of giving informed consent
3. Be willing and able to comply with study-related requirements, procedures.
4. Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
5. Have been diagnosed with OAB
6. Have an average of 10 or more frequency events per day in a 3-Day Voiding Diary
7. Have 2 or more urinary incontinence episodes in a 3-Day Voiding Diary
8. Will be able to provide clear, thoughtful responses to questions and questionnaires
9. Be able to toilet self and have and maintain personal hygiene
10. Be able to sense and tolerate tibial nerve stimulation.
11. If on current medications, be on a stable dose (no new, discontinued, or change in dose) of all prescribed medication for at least 4 weeks prior to the trial
12. Females of childbearing age must have a negative urine pregnancy test at baseline
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, neuropathy or uncontrolled diabetes mellitus
2. Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcomes
3. Be allergic, or have shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body
4. Have a condition currently requiring or likely to require the use of MRI or diathermy
5. Be at risk for an infection or have an active systemic or local infection
6. Have a current Urinary Tract Infection
7. Be unable to keep the dressing clean during and in between visits.
8. Be currently using a marketed device for treatment of their incontinence (including but not limited to Interstim®)
9. Have had Botox treatment for their OAB in the previous 4 months.
10. Have Current use of TENS in pelvic region, back or legs
11. PTNS treatment in the previous 12 weeks prior to enrollment
12. Use of investigational drug/device therapy within past 4 weeks
13. Be concomitantly participating in another clinical study.
14. Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and/or illicit
15. Pregnancy
16. Have prior surgical or trauma scar tissue in the target area for lead implantation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The subject demographics will be tabulated and descriptive statistics will be estimated. These include means (or medians) and standard deviations (or inter-quartile ranges) for continuous or ordinal variables

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment postcode(s) [1] 22783 0
2220 - Hurstville
Recruitment postcode(s) [2] 23925 0
3550 - Bendigo

Funding & Sponsors
Funding source category [1] 299575 0
Commercial sector/Industry
Name [1] 299575 0
Veressa Medical Inc
Address [1] 299575 0
Veressa Medical
1375 Perry St Columbus
Ohio 43201
United States
Country [1] 299575 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Five Corners Pty Ltd
Address
13/76 Reserve Road
Artarmon
NSW 2064
Country
Australia
Secondary sponsor category [1] 298889 0
None
Name [1] 298889 0
Address [1] 298889 0
Country [1] 298889 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300477 0
Bellberry Limited HREC
Ethics committee address [1] 300477 0
129 Glen Osmond Road
Eastwood
SA 5063
Ethics committee country [1] 300477 0
Australia
Date submitted for ethics approval [1] 300477 0
29/12/2017
Approval date [1] 300477 0
20/02/2018
Ethics approval number [1] 300477 0

Summary
Brief summary
This study is a prospective feasibility study evaluating the implantation procedure and stimulation effects of tibial and/or saphenous nerve stimulation on patients with overactive bladder (OAB). Participants who meet the selection criteria will be enrolled in this study will be implanted with a neurostimulator system and randomised (2:1) to receive tibial or saphenous nerve stimulation. The purpose of this study is to evaluate the implantation procedure and stimulation paresthesia of tibial or saphenous nerve stimulation on patients with OAB using a commercial lead and the effects the stimulation has on symptoms of OAB. This study will help in the design a novel implanted stimulator and introducer
and in the development of a larger scale study to evaluate the safety and effectiveness of the implant. All participants will receive stimulation for 5 consecutive days before having their lead removed and returning for a final follow-up visit 14 days post-removal. Participants will be assessed for number of bladder voids, paresthesia coverage & quality, quality of life and incidence of adverse events.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83778 0
Dr William Lynch
Address 83778 0
St George Urology
Suite 205
Waratah Private Hospital
31 Dora Street
Hurstville NSW 2220
Country 83778 0
Australia
Phone 83778 0
+61 2 9553 7110
Fax 83778 0
Email 83778 0
info@uro.net.au
Contact person for public queries
Name 83779 0
Dr William Lynch
Address 83779 0
St George Urology
Suite 205
Waratah Private Hospital
31 Dora Street
Hurstville NSW 2220
Country 83779 0
Australia
Phone 83779 0
+61 2 9553 7110
Fax 83779 0
Email 83779 0
info@uro.net.au
Contact person for scientific queries
Name 83780 0
Dr William Lynch
Address 83780 0
St George Urology
Suite 205
Waratah Private Hospital
31 Dora Street
Hurstville NSW 2220
Country 83780 0
Australia
Phone 83780 0
+61 2 9553 7110
Fax 83780 0
Email 83780 0
info@uro.net.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Informed consent form states that individual data will not be made publicly available.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary