BASIC Study
Research type
Research Study
Full title
Basic Evaluation Lead Post-Market Clinical Follow-up (BASIC) Study
IRAS ID
269558
Contact name
Alice Melotti
Contact email
Sponsor organisation
Medtronic
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 9 months, 31 days
Research summary
The purpose of this study is to gather further information on the use of the InterStim Basic Evaluation lead and accessories, which is a commercially available device.
When the communication between the nerves, brain, bladder and muscles that control urination are not working correctly, the bladder can become overactive resulting in an increased or uncontrollable need to pass urine.
Patients with an overactive bladder can be treated with a procedure called Sacral neuromodulation, which is a device implanted under the skin, that sends small electrical pulses through a lead to the sacral nerves, which are involved in bladder control.
Often a temporary system is first used to assess whether this approach will be suitable and effective for the patient. This is called a Basic Evaluation. This study will use the InterStim Basic Evaluation lead and accessories.
The Sacral nerves are comprised of both motor and sensory nerves. As a result, during Basic Evaluation the electrical impulses can produce a motor or sensory response in patients such as a mild pulling or tingling sensation in the genitals or anus/back passage.
The primary aim of the study is to assess the proportion of subjects who demonstrate a motor or sensory response during the InterStim basic evaluation lead placement.
The study will also review patient satisfaction with the InterStim basic evaluation lead, how easy the device is to use and whether there was any change in the study participants bladder symptoms.
Study participants will need to complete a urinary dairy at the start of the study (baseline) for 3 days to assess if they are good candidates for the therapy, and for maximum 7 days following the InterStim basic evaluation lead placement procedure.
A minimum of 100 patients will be enrolled, at approximately 30 hospitals across Europe, Canada, and the United States.REC name
London - Surrey Research Ethics Committee
REC reference
19/LO/1500
Date of REC Opinion
29 Oct 2019
REC opinion
Further Information Favourable Opinion