Urge Incontinence
Conditions
Keywords
urge/frequency, urge incontinence, Interstim, after success Interstim planning IPG placement
Brief summary
Sacral Nerve Stimulation (SNS) delivers non-painful, mild electrical pulses to the sacral nerves to modulate the reflexes that influence the bladder, sphincter, and pelvic floor to improve or restore normal voiding function. Sacral nerve stimulation is indicated for refractory voiding dysfunction including urinary urgency/frequency, urinary urge incontinence, and nonobstructive urinary retention. Since its introduction, SNS has undergone significant improvements in design and application so that implantation is now a minimally invasive procedure under local and intravenous (IV) sedation. However, despite the progress made in advancing this therapy to a minimally invasive procedure, there are neither data nor guidelines on ideal program settings. The purpose of this study is to evaluate the programming parameter of cyclic versus continuous stimulation on efficacy of the therapy. If the therapy is equally efficacious at both settings, the cyclic setting has the advantage of resulting in a longer battery life.
Detailed description
The components of SNS include a quadripolar lead wire that is placed adjacent to a sacral nerve root (typically S3), and an implantable pulse generator (IPG) that the lead wire is attached to. The IPG provides the electrical impulse and has several parameters that are amenable to adjustment including rate, strength and length of stimulation. Additionally, the stimulation can be programmed to be continuous or cyclic. If the therapy is equally efficacious at both settings, the cyclic setting has the advantage of resulting in a longer battery life. This would prolong the time interval between IPG replacements which would reduce the number of times a patient is exposed to a surgical procedure and may have a substantial impact on reducing cost to the healthcare system. Participants will be randomized into one of two groups: either cyclic stimulation or continuous stimulation after IPG placement and will continue with this setting for four weeks. Subjects will return to the office 4 weeks post-op. They will complete a 3-day consecutive voiding diary just prior to their study visit. The subject will then undergo reprogramming to change the stimulation to the alternate pattern (from cyclic to continuous or vice versa as appropriate) keeping all other parameters the same. Subjects will be asked to return to the office 4 weeks after being switched to the alternate setting. She will complete a 3-day consecutive voiding diary just prior to the visit. The subject will also be asked their preference of mode of stimulation and the reason for their choice. After this visit, the participant will be switched to the mode of stimulation that is most efficacious for her.
Interventions
DEVICEInterstim (SNS)
Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy
Sponsors
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* You are eligible to participate in this study if you have the diagnosis of urge/frequency or urge incontinence and have undergone a successful Interstim trial and are planning on proceeding with IPG placement. * All subjects must have had a minimum of a 50% improvement of one or more of the parameters being measured on the voiding diary to be considered a candidate for implant. * Eligibility criteria also include non-pregnant women over the age of 18 who are able to provide informed consent and are willing to accept randomization.
Exclusion criteria
* You are not eligible to participate in this study if: * you are under 18 years of age; * pregnant or planning to become pregnant; * have underlying neurological disease; * stress incontinence; * unable to read English; * inability to complete the voiding diary; and * inability to complete the follow-up visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Micturitions in 24 Hours | After 4 weeks of stimulation a 3-day consecutive voiding diary was completed | Collected in the 3 day voiding diary depending on their primary diagnosis |
| Number of Urge Incontinence Episodes in 24 Hours | After 4 weeks of stimulation a 3-day consecutive voiding diary was completed | Collected in the 3 day voiding diary depending on their primary diagnosis |
Countries
United States
Participant flow
Recruitment details
Medical clinic over the course of 2 years
Pre-assignment details
No participants were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Interstim - Continuous Stimulation First, Then Cyclic Stimulation Continuous stimulation
Interstim (SNS) : Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy | 18 |
| Interstim - Cyclic Stimulation First, Then Continuous Stimulation Cyclic stimulation
Interstim (SNS) : Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy | 14 |
| Total | 32 |
Baseline characteristics
| Characteristic | Interstim - Cyclic Stimulation First, Then Continuous Stimulation | Interstim - Continuous Stimulation First, Then Cyclic Stimulation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 9 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 9 Participants | 16 Participants |
| Age, Continuous | 63.4 years STANDARD_DEVIATION 10.8 | 65.6 years STANDARD_DEVIATION 12.3 | 64.6 years STANDARD_DEVIATION 11.6 |
| Region of Enrollment United States | 14 participants | 18 participants | 32 participants |
| Sex: Female, Male Female | 14 Participants | 18 Participants | 32 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 14 |
| other Total, other adverse events | 0 / 18 | 0 / 14 |
| serious Total, serious adverse events | 0 / 18 | 0 / 14 |
Outcome results
Primary
Number of Micturitions in 24 Hours
Collected in the 3 day voiding diary depending on their primary diagnosis
Time frame: After 4 weeks of stimulation a 3-day consecutive voiding diary was completed
Population: Data was insufficient to be analyzed and therefore no resulting data was collected.
Primary
Number of Urge Incontinence Episodes in 24 Hours
Collected in the 3 day voiding diary depending on their primary diagnosis
Time frame: After 4 weeks of stimulation a 3-day consecutive voiding diary was completed
Population: Data was insufficient to be analyzed and therefore no resulting data was collected.