Plain English Summary
Background and study aims
When people have an overactive bladder or bowel incontinence they have problems with their bladder-storage function or with an inability to control bowel movements. This happens because there is muscle and nerve damage that is associated with things like aging or giving birth. An overactive bladder or bowel incontinence is usually treated with various behavioral techniques, such as exercises to train bladder or bowel training, and medication. If these treatments failed, then a treatment called nerve stimulation is often used. This procedure uses a thin wire placed close to the sacrum (tailbone) where it passes near the sacral nerves which carry signals to the bladder and muscles in the bowel. This procedure is often done with a trial of a temporary wire or as an advanced procedure in which the permanent electrode (conductor) is implanted. When the doctors perform the placement, they use an imaging tool called fluoroscopy that guides them while the stimulator wire is being placed. This is a type of medical imaging that shows an X-ray image on a monitor. During a fluoroscopy procedure, an X-ray beam is passed through the body. The image is transmitted to a monitor so the movement of an instrument through the body can be seen in detail. The use of x-rays carries a minor risk as it uses radiator. Ultrasound imaging (sonography) uses high-frequency sound waves. Because ultrasound images are captured in real-time, they can also show movement of the body's internal organs as well as blood flowing through the blood vessels. Unlike X-ray imaging, there is no ionizing radiation exposure associated with ultrasound imaging. The aim of this study is to look at the effectiveness of ultrasound imaging to implant the InterStim® neurostimulator (a nerve stimulation device).
Who can participate?
Adults with overactive bladder or bowel incontinence for whom standard treatments using exercises or medication have not worked.
What does the study involve?
Participants are randomly allocated to one of two groups. Participants in both groups have the InterStim® neurostimulator device implanted in the sacral (tailbone) region using standard surgical techniques. Those in the first group have the device placed using fluoroscopy to guide placement of needles. This involves using a special x-ray machine to continually take pictures to show where the device should be placed. Those in the second group have the device placed under ultrasound guidance. This involves using an ultrasound probe to show the area of interest on a monitor so the device can be correctly placed. The time taken to perform the procedures is recorded in both groups. At the start of the study, two weeks after surgery and two years later, participants in both groups complete questionnaires to assess their quality of life.
What are the possible benefits and risks of participating?
Participants in the ultrasound group may benefit from not being exposed to radiation from x-rays. There are no notable risks involved with participating.
Where is the study run from?
Metro Health Hospital (USA)
When is the study starting and how long is it expected to run for?
January 2015 to March 2018
Who is funding the study?
Metro Health Hospital (USA)
Who is the main contact?
Dr Jaschar Shakuri-Rad
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2015-005
Study information
Scientific title
Prospective randomized blinded study evaluating ultrasound versus fluoroscopy guided sacral InterStim® lead placement
Acronym
Study hypothesis
Study aim:
The aim of the study is to compare outcomes of ultrasound versus fluoroscopically guided placement of sacral neuromodulation foramen needles.
Hypothesis:
Ultrasound guided placement will significantly reduce fluoroscopy time and produce equivalent patient symptom control.
Ethics approval
Metro Health Institutional Review Board, 03/03/2015, ref: 2015-005
Study design
Single-center blinded prospective randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Overactive bladder, fecal incontinence
Intervention
Eligible participants are randomly assigned into either the fluoroscopy or ultrasound group. Randomization is performed using a computer generated randomization number which assigns each patient to either the fluoroscopy or ultrasound arm. The surgeon is blinded to randomization until just prior to the start of the procedure. Patients are blinded to randomization for the duration of the study.
Group 1: Participants undergo placement of InterStim neurostimulator foramen needles under fluoroscopic guidance. This involves placing the patient prone on the operating room table. After induction of anesthesia, a foramen needle is placed in the S3 foramen under live fluoroscopy (continuous x-ray). Once adequate position of the needle is confirmed, the remainder of the procedure is performed per manufacturers recommendations (Please see www.medtronic.com for details).
Group 2: Participants undergo placement of InterStim neurostimulator foramen needles under ultrasound guidance. This involves placing the patient prone on the operating room table. After induction of anesthesia, a foramen needle is advanced into the S3 foramen under live ultrasound guidance. Once adequate position of the needle is confirmed, the remainder of the procedure is performed per manufacturers recommendations (please see www.medtronic.com for details).
Patients in both groups are then followed for two years under the current study protocol to determine long term outcomes.
Intervention type
Device
Phase
Drug names
Primary outcome measures
Overall surgery time is measured in seconds until the end of surgery
Secondary outcome measures
1. Number of skin punctures made during the surgical procedure
2. Quality of life is assessed using the following questionnaires at baseline, 4 weeks and 2 years:
2.1. The International Consultation on Incontinence Modular Questionnaire Overactive Bladder Symptoms Quality of Life (ICIQ-OABqol) for urinary symptoms
2.2. The Overactive Bladder Symptom Score (OABSS) for urinary symptoms
2.3. The Fecal Incontinence Quality of Life Scale (FIQL) for fecal incontinence
Overall trial start date
20/01/2015
Overall trial end date
03/03/2018
Reason abandoned
Eligibility
Participant inclusion criteria
1. Diagnosis of overactive bladder, non-obstructive urinary retention, or fecal incontinence
2. Aged 18 years or older
3. Failure of previous conservative measures (i.e. behavior modification, biofeedback, pelvic floor training, at least one antimuscarinic or beta-agonist medication)
4. Medically fit to undergo proposed surgery
5. Patient able to consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Forty in total. Twenty in each arm.
Participant exclusion criteria
1. Pregnant or planning on becoming pregnant
2. Severe or uncontrolled diabetes with peripheral nerve involvement
3. Knowledge of planned MRI or other procedures precluding implantation of device or need for removal
4. Severe BPH, prostate cancer, urethral stricture, or other mechanical obstruction
5. Active urinary tract, skin, or soft tissue infection
Recruitment start date
04/03/2015
Recruitment end date
03/03/2016
Locations
Countries of recruitment
United States of America
Trial participating centre
Metro Health Hospital
5900 Byron Center Ave
Wyoming
49519
United States of America
Sponsor information
Organisation
Metro Health Hospital
Sponsor details
5900 Byron Center Ave
Wyoming
49519
United States of America
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Metro Health Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Plans to share and/or publish the results of this study through means of medical journals, posters, and scientific seminars.
IPD Sharing plan:
Planned publication of participant level data in a peer reviewed journal. Any additional information or data may be obtained after a formal request, which may have to be approved by our IRB department to ensure patient data protection as outlined in local, state, and national guidelines (HIPPA).
Intention to publish date
31/03/2017
Participant level data
Other
Results - basic reporting
Publication summary