Skip to content

Sacral neuromodulation for the treatment of detrusor hyperreflexia with impaired contractility (DHIC)

Sacral neuromodulation for the treatment of detrusor hyperreflexia with impaired contractility (DHIC)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001576415
Acronym
SDOIC Trial
Enrollment
20
Registered
2016-11-15
Start date
2015-08-06
Completion date
2018-09-30
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

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 was first described by Resnick in 1987, as the second most common cause of urinary incontinence in institutionalized elderly people. Although initially described in frail institutionalized elderly, DHIC has been increasingly recognized as a cause of lower urinary tract symptoms (LUTS) in elderly patients . DHIC was identified as the principal dysfunction in up to 8-18% of elderly patients referred for urodynamic studies, furthermore DHIC was more commonly seen in men. There is no defined treatment algorithm for patients with DHIC, but typically, patients have been treated based on the severity of their particular symptoms. Sacral neuromodulation (SNM) is currently approved as a treatment for both idiopathic DO, and non-obstructive urinary retention independently. 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.

Interventions

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

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.

Sponsors

Dr Johan Gani
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All patients with urodynamically proven DHIC are included in study.

Exclusion criteria

Patients with evidence bladder outlet (BOO), pelvic organ prolapse, stress urinary incontinence, and neurogenic bladder are excluded

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026