Trial Outcomes & Findings for Cyclic Versus Continuous Sacral Neuromodulation for LUTS (NCT NCT06170450)
NCT ID: NCT06170450
Last Updated: 2026-07-24
Results Overview
ICIQ-OABqol is a 28 question patient-completed survey evaluating quality of life (QoL) in patients with overactive bladder. Score ranges 25-160 points with greater value indicating increased impact on quality of life.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Baseline to 12 months post-operatively
Results posted on
2026-07-24
Participant Flow
Participant milestones
| Measure |
Cyclic SNM
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to cycling stimulation program mode.
Cyclic SNM: SNM cycling: 8 hours on, 16 hours off
|
Continuous SNM
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to continuous stimulation programming (SNM is continuously stimulating without "off" periods)
Continuous SNM: Continuous SNM: on continuously, no 'off' period
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
21
|
24
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Cyclic SNM
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to cycling stimulation program mode.
Cyclic SNM: SNM cycling: 8 hours on, 16 hours off
|
Continuous SNM
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to continuous stimulation programming (SNM is continuously stimulating without "off" periods)
Continuous SNM: Continuous SNM: on continuously, no 'off' period
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
Baseline Characteristics
Cyclic Versus Continuous Sacral Neuromodulation for LUTS
Baseline characteristics by cohort
| Measure |
Cyclic SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to cycling stimulation program mode.
Cyclic SNM: SNM cycling: 8 hours on, 16 hours off
|
Continuous SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to continuous stimulation programming (SNM is continuously stimulating without "off" periods)
Continuous SNM: Continuous SNM: on continuously, no 'off' period
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=9 Participants
|
22 Participants
n=27 Participants
|
42 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Age, Continuous
|
69 years
STANDARD_DEVIATION 11 • n=9 Participants
|
68 years
STANDARD_DEVIATION 10 • n=27 Participants
|
68 years
STANDARD_DEVIATION 11 • n=267 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=9 Participants
|
25 Participants
n=27 Participants
|
50 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 months post-operativelyICIQ-OABqol is a 28 question patient-completed survey evaluating quality of life (QoL) in patients with overactive bladder. Score ranges 25-160 points with greater value indicating increased impact on quality of life.
Outcome measures
| Measure |
Cyclic SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to cycling stimulation program mode.
Cyclic SNM: SNM cycling: 8 hours on, 16 hours off
|
Continuous SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to continuous stimulation programming (SNM is continuously stimulating without "off" periods)
Continuous SNM: Continuous SNM: on continuously, no 'off' period
|
|---|---|---|
|
Change in ICIQ-OAB-QoL Score
|
-29.4 change in score on a scale
95% Confidence Interval 33 • Interval -43.5 to -15.3
|
-27.0 change in score on a scale
95% Confidence Interval 36 • Interval -40.5 to -13.5
|
SECONDARY outcome
Timeframe: 1 month, 6 months post-operativelyICIQ-OABqol is a 28 question patient-completed survey evaluating quality of life (QoL) in patients with overactive bladder. Score ranges 25-160 points with greater value indicating increased impact on quality of life
Outcome measures
| Measure |
Cyclic SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to cycling stimulation program mode.
Cyclic SNM: SNM cycling: 8 hours on, 16 hours off
|
Continuous SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to continuous stimulation programming (SNM is continuously stimulating without "off" periods)
Continuous SNM: Continuous SNM: on continuously, no 'off' period
|
|---|---|---|
|
Change in ICIQ-OAB-QoL Score
1 month post-operatively
|
-40.0 change in score on a scale
95% Confidence Interval 30 • Interval -51.1 to -28.8
|
-45.7 change in score on a scale
95% Confidence Interval 26 • Interval -56.9 to -34.5
|
|
Change in ICIQ-OAB-QoL Score
6 months post-operatively
|
-25.3 change in score on a scale
95% Confidence Interval 34 • Interval -37.3 to -13.4
|
-44.0 change in score on a scale
95% Confidence Interval 32 • Interval -55.9 to -32.1
|
SECONDARY outcome
Timeframe: 1 month, 6 months, 12 months post-operativelyOAB-q SF is a 19 question patient-completed survey evaluating symptom bother and quality of life in patients with overactive bladder. Scores range 3- 36, higher values indicating increased symptom severity
Outcome measures
| Measure |
Cyclic SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to cycling stimulation program mode.
Cyclic SNM: SNM cycling: 8 hours on, 16 hours off
|
Continuous SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to continuous stimulation programming (SNM is continuously stimulating without "off" periods)
Continuous SNM: Continuous SNM: on continuously, no 'off' period
|
|---|---|---|
|
Change in OAB-q SF
1 month post-operatively
|
-11.1 Change in score on a scale
95% Confidence Interval 6 • Interval -14.1 to -8.2
|
-12.2 Change in score on a scale
95% Confidence Interval 9 • Interval -15.2 to -9.2
|
|
Change in OAB-q SF
6 months post- operatively
|
-7.1 Change in score on a scale
95% Confidence Interval 9 • Interval -10.2 to -4.1
|
-11.9 Change in score on a scale
95% Confidence Interval 8 • Interval -15.0 to -8.9
|
|
Change in OAB-q SF
12 months post-operatively
|
-7.9 Change in score on a scale
95% Confidence Interval 7 • Interval -11.4 to -4.5
|
-8.0 Change in score on a scale
95% Confidence Interval 9 • Interval -11.3 to -4.6
|
SECONDARY outcome
Timeframe: 1 month, 6 months, 12 months post-operativelyThe Overactive Bladder Symptom Score (OABSS) is a 4 question validated symptom assessment tool for patients with OAB and assesses number of episodes of frequency, nocturia, urgency, and urge incontinence. Scores range 0-15 with higher scores indicating higher severity.
Outcome measures
| Measure |
Cyclic SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to cycling stimulation program mode.
Cyclic SNM: SNM cycling: 8 hours on, 16 hours off
|
Continuous SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to continuous stimulation programming (SNM is continuously stimulating without "off" periods)
Continuous SNM: Continuous SNM: on continuously, no 'off' period
|
|---|---|---|
|
Change in Overactive Bladder Symptom Score (OABSS)
6 months post-operatively
|
-1.9 Change in score on a scale
95% Confidence Interval 3 • Interval -3.3 to -0.5
|
-4.5 Change in score on a scale
95% Confidence Interval 4 • Interval -5.9 to -3.2
|
|
Change in Overactive Bladder Symptom Score (OABSS)
12 months post-operatively
|
-2.6 Change in score on a scale
95% Confidence Interval 3 • Interval -4.1 to -1.2
|
-2.6 Change in score on a scale
95% Confidence Interval 4 • Interval -4.0 to -1.2
|
|
Change in Overactive Bladder Symptom Score (OABSS)
1 month post-operatively
|
-3.7 Change in score on a scale
95% Confidence Interval 3 • Interval -5.0 to -2.4
|
-5.3 Change in score on a scale
95% Confidence Interval 4 • Interval -6.7 to -4.0
|
SECONDARY outcome
Timeframe: 1 month, 6 months, 12 months post-operativelyIncontinence Impact Questionnaire SF (IIQ-7) is a 7-item validated questionnaire that assesses urinary symptoms, the symptom bother, and the impact the bother has on patients' quality of life using a 4-point bother scale. Scores range 0-100 (raw score multiplied by 33 1/3 to transform scale) with higher scores indicating higher bother
Outcome measures
| Measure |
Cyclic SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to cycling stimulation program mode.
Cyclic SNM: SNM cycling: 8 hours on, 16 hours off
|
Continuous SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to continuous stimulation programming (SNM is continuously stimulating without "off" periods)
Continuous SNM: Continuous SNM: on continuously, no 'off' period
|
|---|---|---|
|
Change in Incontinence Impact Questionnaire SF (IIQ-7)
1 month post-operatively
|
-39.9 Change in score on a scale
95% Confidence Interval 32 • Interval -51.6 to -28.3
|
-46.6 Change in score on a scale
95% Confidence Interval 31 • Interval -58.4 to -34.9
|
|
Change in Incontinence Impact Questionnaire SF (IIQ-7)
6 months post-operatively
|
-25.9 Change in score on a scale
95% Confidence Interval 37 • Interval -38.2 to -13.5
|
-49.0 Change in score on a scale
95% Confidence Interval 31 • Interval -61.3 to -36.7
|
|
Change in Incontinence Impact Questionnaire SF (IIQ-7)
12 months post-operatively
|
-25.7 Change in score on a scale
95% Confidence Interval 34 • Interval -40.0 to -11.3
|
-34.6 Change in score on a scale
95% Confidence Interval 39 • Interval -48.6 to -20.6
|
SECONDARY outcome
Timeframe: 1 month, 6 months, 12 months post-operativelyUrinary Distress Inventory SF (UDI-6) is a 6 item validated questionnaire that assesses urinary symptoms, the symptom bother, and the impact the bother has on patients' quality of life using a 4-point bother scale. Scores 6 items, range 0-100 (raw score multiplied by 33 1/3 to transform scale) with higher scores indicating higher distress.
Outcome measures
| Measure |
Cyclic SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to cycling stimulation program mode.
Cyclic SNM: SNM cycling: 8 hours on, 16 hours off
|
Continuous SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to continuous stimulation programming (SNM is continuously stimulating without "off" periods)
Continuous SNM: Continuous SNM: on continuously, no 'off' period
|
|---|---|---|
|
Urinary Distress Inventory SF (UDI-6)
1 month post-operatively
|
-20.7 Change in score on a scale
95% Confidence Interval 21 • Interval -28.7 to -12.7
|
-36.2 Change in score on a scale
95% Confidence Interval 21 • Interval -44.3 to -28.1
|
|
Urinary Distress Inventory SF (UDI-6)
6 months post-operatively
|
-15.4 Change in score on a scale
95% Confidence Interval 29 • Interval -23.7 to -7.0
|
-34.6 Change in score on a scale
95% Confidence Interval 19 • Interval -42.9 to -26.3
|
|
Urinary Distress Inventory SF (UDI-6)
12 months post-operatively
|
-15.0 Change in score on a scale
95% Confidence Interval 20 • Interval -24.3 to -5.7
|
-25.5 Change in score on a scale
95% Confidence Interval 25 • Interval -34.6 to -16.5
|
SECONDARY outcome
Timeframe: 1 month, 6 months, 12 months post-operativelyPatient Global Impression of Severity (PGI-S) is a 1-item 4-point scale designed to assess for disease severity where 1 indicates "normal," 2 is "mild," 3 is "moderate," and 4 is "severe." Outcome measured is number of participants per group who reported disease is "severe" at each timepoint.
Outcome measures
| Measure |
Cyclic SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to cycling stimulation program mode.
Cyclic SNM: SNM cycling: 8 hours on, 16 hours off
|
Continuous SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to continuous stimulation programming (SNM is continuously stimulating without "off" periods)
Continuous SNM: Continuous SNM: on continuously, no 'off' period
|
|---|---|---|
|
Patient Global Impression of Severity (PGI-S)
1 month post-operatively
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGI-S)
12 months post-operatively
|
5 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGI-S)
6 months post-operativley
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 1 month, 6 months, 12 months post-operativelyPatient Global Impression of Improvement (PGI-I) is a 1-item scale designed to assess symptom improvement with answer choices: Very much better, Much better, A little better, No change, A little worse, Much worse, Very much worse. Outcome measure includes number of participants per group who reported "very much better" or "much better" at each timepoint
Outcome measures
| Measure |
Cyclic SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to cycling stimulation program mode.
Cyclic SNM: SNM cycling: 8 hours on, 16 hours off
|
Continuous SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to continuous stimulation programming (SNM is continuously stimulating without "off" periods)
Continuous SNM: Continuous SNM: on continuously, no 'off' period
|
|---|---|---|
|
Patient Global Impression of Improvement (PGI-I)
1 month post-operatively
|
9 Participants
|
14 Participants
|
|
Patient Global Impression of Improvement (PGI-I)
6 months post-operatively
|
7 Participants
|
14 Participants
|
|
Patient Global Impression of Improvement (PGI-I)
12 months post-operatively
|
11 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 1 month, 6 months, 12 months post-operativelyChange in Overactive Bladder Satisfaction of Treatment Questionnaire (OAB-SAT-q) is an 11-item validated questionnaire that assesses patients' satisfaction with their OAB treatment within a clinical setting from baseline. Score range 0-100 with higher scores indicating greater treatment satisfaction
Outcome measures
| Measure |
Cyclic SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to cycling stimulation program mode.
Cyclic SNM: SNM cycling: 8 hours on, 16 hours off
|
Continuous SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to continuous stimulation programming (SNM is continuously stimulating without "off" periods)
Continuous SNM: Continuous SNM: on continuously, no 'off' period
|
|---|---|---|
|
Overactive Bladder Satisfaction of Treatment Questionnaire
6 months post-operatively
|
67.3 score on a scale
95% Confidence Interval 22 • Interval 58.9 to 75.8
|
76.9 score on a scale
95% Confidence Interval 20 • Interval 68.8 to 85.1
|
|
Overactive Bladder Satisfaction of Treatment Questionnaire
12 months post-operatively
|
68.3 score on a scale
95% Confidence Interval 16 • Interval 60.4 to 76.1
|
70.5 score on a scale
95% Confidence Interval 13 • Interval 63.0 to 78.0
|
|
Overactive Bladder Satisfaction of Treatment Questionnaire
1 month post-operatively
|
73.5 score on a scale
95% Confidence Interval 13 • Interval 64.1 to 83.0
|
77.8 score on a scale
95% Confidence Interval 22 • Interval 68.5 to 87.1
|
SECONDARY outcome
Timeframe: 1 month, 6 months, 12 months post-operativelyPatients will use 3 days bladder diaries to track voiding episodes per day, voiding episodes per night, pads per day, and urge incontinence episodes per day. Daily voiding frequency will be the voiding episodes per day averaged over 3 day bladder diary.
Outcome measures
| Measure |
Cyclic SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to cycling stimulation program mode.
Cyclic SNM: SNM cycling: 8 hours on, 16 hours off
|
Continuous SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to continuous stimulation programming (SNM is continuously stimulating without "off" periods)
Continuous SNM: Continuous SNM: on continuously, no 'off' period
|
|---|---|---|
|
Change in Voiding Episodes Per Day
1 month post-operatively
|
-3.2 Voiding episodes per day
Interval -4.1 to -2.3
|
-3.3 Voiding episodes per day
Interval -4.2 to -2.3
|
|
Change in Voiding Episodes Per Day
6 months post-operatively
|
-2.2 Voiding episodes per day
Interval -3.3 to -1.1
|
-3.1 Voiding episodes per day
Interval -4.2 to -2.0
|
|
Change in Voiding Episodes Per Day
12 months post-operatively
|
-2.5 Voiding episodes per day
Interval -3.9 to -1.2
|
-2.4 Voiding episodes per day
Interval -3.7 to -1.1
|
SECONDARY outcome
Timeframe: 1 month, 6 months, 12 months post-operativelyPatients will use 3 day bladder diaries to track voiding episodes per day, voiding episodes per night, pads per day, and urge incontinence episodes. Voiding episodes per night will be voiding episodes per night averaged over 3 day bladder diary.
Outcome measures
| Measure |
Cyclic SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to cycling stimulation program mode.
Cyclic SNM: SNM cycling: 8 hours on, 16 hours off
|
Continuous SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to continuous stimulation programming (SNM is continuously stimulating without "off" periods)
Continuous SNM: Continuous SNM: on continuously, no 'off' period
|
|---|---|---|
|
Change in Voiding Episodes Per Night
1 month post-operatively
|
-0.9 Voiding episodes per night
Interval -1.4 to -0.3
|
-0.9 Voiding episodes per night
Interval -1.4 to -0.3
|
|
Change in Voiding Episodes Per Night
6 months post-operatively
|
-0.02 Voiding episodes per night
Interval -0.7 to 0.7
|
-1.1 Voiding episodes per night
Interval -1.8 to -0.4
|
|
Change in Voiding Episodes Per Night
12 months post-operatively
|
-0.1 Voiding episodes per night
Interval -1.0 to 0.8
|
-0.3 Voiding episodes per night
Interval -1.1 to 0.6
|
SECONDARY outcome
Timeframe: 1 month, 6 months, 12 months post-operativelyPatients will use 3 day bladder diaries to track voiding episodes per day, voiding episodes per night, pads per day, and urge incontinence episodes. Pads per day will be the pad count per day averaged over 3 day bladder diary.
Outcome measures
| Measure |
Cyclic SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to cycling stimulation program mode.
Cyclic SNM: SNM cycling: 8 hours on, 16 hours off
|
Continuous SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to continuous stimulation programming (SNM is continuously stimulating without "off" periods)
Continuous SNM: Continuous SNM: on continuously, no 'off' period
|
|---|---|---|
|
Change in Pads Per Day
1 month post-operatively
|
-1.8 Pads per day
Interval -2.7 to -0.9
|
-2.4 Pads per day
Interval -3.3 to -1.6
|
|
Change in Pads Per Day
6 months post-operatively
|
-0.1 Pads per day
Interval -1.2 to 0.9
|
-1.9 Pads per day
Interval -2.9 to -0.9
|
|
Change in Pads Per Day
12 months post-operatively
|
-0.6 Pads per day
Interval -1.9 to 0.7
|
-1.3 Pads per day
Interval -2.6 to 0.02
|
SECONDARY outcome
Timeframe: 1 month, 6 months, 12 months post-operativelyPatients will use 3 day bladder diaries to track voiding episodes per day, voiding episodes per night, pad count per day, and urge incontinence episodes per day. Urge incontinence episodes will be the urge incontinence episodes per day averaged over 3 day bladder diary.
Outcome measures
| Measure |
Cyclic SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to cycling stimulation program mode.
Cyclic SNM: SNM cycling: 8 hours on, 16 hours off
|
Continuous SNM
n=25 Participants
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to continuous stimulation programming (SNM is continuously stimulating without "off" periods)
Continuous SNM: Continuous SNM: on continuously, no 'off' period
|
|---|---|---|
|
Change in Urge Incontinence Episodes Per Day
1 month post-operatively
|
-3.1 Urge incontinence episodes per
Interval -4.1 to -2.0
|
-4.5 Urge incontinence episodes per
Interval -5.7 to -3.4
|
|
Change in Urge Incontinence Episodes Per Day
6 months post-operatively
|
-1.8 Urge incontinence episodes per
Interval -2.9 to -0.6
|
-3.4 Urge incontinence episodes per
Interval -4.5 to -2.2
|
|
Change in Urge Incontinence Episodes Per Day
12 months post-operatively
|
-2.7 Urge incontinence episodes per
Interval -4.2 to -1.2
|
-1.9 Urge incontinence episodes per
Interval -3.4 to -0.5
|
Adverse Events
Cyclic SNM
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Continuous SNM
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cyclic SNM
n=25 participants at risk
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to cycling stimulation program mode.
Cyclic SNM: SNM cycling: 8 hours on, 16 hours off
|
Continuous SNM
n=25 participants at risk
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to continuous stimulation programming (SNM is continuously stimulating without "off" periods)
Continuous SNM: Continuous SNM: on continuously, no 'off' period
|
|---|---|---|
|
Nervous system disorders
Reported uncomfortable stimulation
|
32.0%
8/25 • Number of events 8 • 12 months
|
40.0%
10/25 • Number of events 10 • 12 months
|
|
Infections and infestations
Device infection
|
0.00%
0/25 • 12 months
|
4.0%
1/25 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Surgical removal of device due to infection
|
0.00%
0/25 • 12 months
|
4.0%
1/25 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Surgical revision of device due to malpositioning
|
8.0%
2/25 • Number of events 2 • 12 months
|
4.0%
1/25 • Number of events 1 • 12 months
|
Additional Information
David Sheyn
University Hospitals Cleveland Medical Center
Phone: 440-285-6465
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place