Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001576415
Ethics application status
Approved
Date submitted
4/10/2016
Date registered
15/11/2016
Date last updated
6/11/2019
Date data sharing statement initially provided
3/12/2018
Date results provided
3/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Sacral neuromodulation for the treatment of detrusor hyperreflexia with impaired contractility (DHIC)
Scientific title
Sacral neuromodulation for the treatment of detrusor hyperreflexia with impaired contractility (DHIC)
Secondary ID [1] 290262 0
None
Universal Trial Number (UTN)
U1111-1188-3249
Trial acronym
SDOIC Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Detrusor overactivty and impaired bladder contraction 300490 0
Condition category
Condition code
Renal and Urogenital 300345 300345 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Detrusor hyperactivity with impaired contractility (DHIC) is a common clinical entity that is poorly understood, under-recognized, and difficult to effectively manage. It is a condition in which patients unexpectedly display detrusor overactivity (DO) during storage, yet are unable to mount a sufficient detrusor contraction during voiding to completely empty the bladder. It is theorised that SNM would potentially treat both aspects of DHIC, the DO and poorly contractile bladder. Currently, there are no studies evaluating the efficacy of SNM for DHIC. In this study, we aim to evaluate the efficacy of SNM for treating DHIC.
Patients with urodynamically proven DHIC will undergo a two stage surgical procedure performed under general anaesthesia (GA) and then local anaesthesia with sedation. The 1st stage procedure will involve a tined lead insertion into the S3 foramina and corresponding nerve root. This procedure is performed with the patient in the prone position and under GA. This tined lead is connected to an external battery and a trial of SNS.
Patients are trialled for 2 weeks (occasionally 3 weeks). Patients stay on the same program for the trial duration, unless their response is lower than a 50% improvement in symptoms. Symptom parameters are measured using a Patient Management Worksheet. For patients with DHIC we initially generally leave them on one program for at least 5 days. At this point if their symptoms have not improved we then consider changing their program. Patients can change their own program during the trial and after consultation. Patients document symptom control for each program. The duration of each programming session will be approximately 20 minutes. The programming will be done by a specialist representative from Medtronic who has specialist training in SNS programming and the senior author of the study.

During a trial, patients can access 3 programs stored in their SNS controller. Patients are usually given C1, C2, & C3 or C2, C3 & C4 depending on motor response in theatre, amplitude limit and patient comfort.

Different controller program specifications
C1: Electrode combination 0-/3+, Time 210 micro seconds, Frequency 25 Hz
C2: Electrode combination 1-/3+, Time 210 micro seconds, Frequency 25 Hz
C3: Electrode combination 2-/0+, Time 210 micro seconds, Frequency 25 Hz
C4: Electrode combination 3-/0+, Time 210 micro seconds, Frequency 25 Hz
C5: Electrode combination ,1-/3+, Time 210 micro seconds, Frequency 25 Hz
C6: Electrode combination 1-,2-/3+ 2, Time 210 micro seconds, Frequency 25 Hz
C6: Electrode combination -,3-/0+, Time 210 micro seconds, Frequency 25 Hz

Thus settings be a will adjusted on a case-by-case basis to provide optimal patient symptom relief, minimize patient discomfort, and maximize neurostimulator battery life. Patients that report an improvement of greater than 50% in urgency, urge incontinence, and frequency will be offered a stage 2 procedure. The stage 2 procedure is performed in the lateral position under sedation. If the patient has had an adequate response that the implantable battery is placed in a tissue pocket in the buttock. The duration of SNS is indefinite if the patient has a good response. Adherence to the desired treatment and device function will be check by 6 month interrogation of the Medtronic sacral nerve stimulator.
Intervention code [1] 296057 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299805 0
Patients that underwent a stage 2 procedure and had a implantable battery placed will be followed up for improvement in there lower urinary tract symptoms.

Treatment response will be assessed by nternational Consultation on Incontinence Modular Questionnaire on overactive bladder (ICIQ-OAB),
Timepoint [1] 299805 0
These indices will be recorded at baseline, two weeks post first stage 2 procedure, and at 3 months, 6 months and 12 months post procedure to assess treatment response. Success will defined as greater than 50% symptom improvement in urgency, urge incontinence, and frequency,
Primary outcome [2] 299963 0
Patients will also examined for improvements in voiding. Median voided volumes, median post void residual volumes (PVR) by clean intermittent catheterization (CIC) will be examined
Timepoint [2] 299963 0
These indices will be recorded at baseline, two weeks post first stage 2 procedure, and at 3 months, 6 months and 12 months post procedure to assess treatment response. Success will defined as greater than 50% reduction in PVR,
Secondary outcome [1] 328181 0
Patient experience and response to treatment will be patient Global Impression of Improvement (PGI-I).
Timepoint [1] 328181 0
These indices will be recorded at baseline, two weeks post first stage 2 procedure, and at 3 months, 6 months and 12 months post procedure

Eligibility
Key inclusion criteria
All patients with urodynamically proven DHIC are included in study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with evidence bladder outlet (BOO), pelvic organ prolapse, stress urinary incontinence, and neurogenic bladder are excluded

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Pending

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/08/2015
Date of last participant enrolment
Anticipated
Actual
30/09/2018
Date of last data collection
Anticipated
1/12/2019
Actual
2/11/2018
Sample size
Target
15
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6765 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 6766 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 14411 0
3084 - Heidelberg
Recruitment postcode(s) [2] 14412 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 294630 0
Self funded/Unfunded
Name [1] 294630 0
Dr Johan Gani
Country [1] 294630 0
Australia
Primary sponsor type
Individual
Name
Dr Johan Gani
Address
Melbourne Bladder clinic
49 Erin Street
Richmond
Victoria 3121
Country
Australia
Secondary sponsor category [1] 293494 0
None
Name [1] 293494 0
Address [1] 293494 0
Country [1] 293494 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296071 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 296071 0
Ethics committee country [1] 296071 0
Australia
Date submitted for ethics approval [1] 296071 0
04/05/2015
Approval date [1] 296071 0
16/06/2015
Ethics approval number [1] 296071 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69442 0
Mr Johan Gani
Address 69442 0
Melbourne Bladder Clinic
49 Erin Street
Richmond
Victoria 3121
Country 69442 0
Australia
Phone 69442 0
+61 3 9428 2232
Fax 69442 0
Email 69442 0
[email protected]
Contact person for public queries
Name 69443 0
Derek Hennessey
Address 69443 0
Austin Health
Department of Urology
145 Studley Road
Heidelberg
Victoria 3084
Country 69443 0
Australia
Phone 69443 0
+61 3 9496 5000
Fax 69443 0
Email 69443 0
[email protected]
Contact person for scientific queries
Name 69444 0
Derek Hennessey
Address 69444 0
Austin Health
Department of Urology
145 Studley Road
Heidelberg
Victoria 3084
Country 69444 0
Australia
Phone 69444 0
+61 3 9496 5000
Fax 69444 0
Email 69444 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data is anonymous and No IPD is available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.