Trial Outcomes & Findings for Cycling Versus Continuous Mode in Neuromodulator Programming (NCT NCT02551822)
NCT ID: NCT02551822
Last Updated: 2018-04-27
Results Overview
The Overactive Bladder Questionnaire (OAB-q) assesses symptom bother \& health-related quality of life (HRQL) for overactive bladder. The short form OAB-q SF, provides a quick assessment of symptom bother, consisting of a 6-item symptom bother scale. The questionnaire is on a 6 point scale, 1 indicates symptom is not bothersome (best outcome), 6 indicates symptom bothers the participant "a very great deal" (worst possible outcome). The majority of the participants were missing the HRQL portion of the questionnaire, so this portion of the questionnaire was not included in the analysis. These are the raw scores ranges for each question prior to being transformed. The possible scores for complete surveys range from 13 (if the participant marked "not bothersome" for all 6) to 78 (if the participant marked "a very great deal" for all 6 questions) once transformed. The reported numbers are the transformed scores \[(actual raw score-lowest possible score)/possible raw score range\] X 100.
COMPLETED
NA
32 participants
Three months after change in program from cycling to continuous or vice versa.
2018-04-27
Participant Flow
9 participants were withdrawn or lost to follow-up prior to randomization. 32 participants enrolled and 23 were randomized.
Participant milestones
| Measure |
Cycling, Then Continuous
Women will be randomized to the continuing or cycling arm at 0 months. At 3 months, women will report for their second postoperative visit. Prior to this visit, study subjects will complete the third 3-day voiding diary and record pad usage. At the visit, women will complete the OAB-q SF as well as the PGI-I, and will be queried regarding any complications since the start of the use of their modulator. At the 3 month visit, women who were assigned to continuous stimulation will be switched to cycling stimulation and women who were assigned to cycling stimulation will be switched to continuous stimulation. Women again will report for clinical follow-up at six months. Women will be asked to complete a fourth 3 day voiding diary. In addition, women will be asked to record any complications that they have had in the preceding 3 months. At this clinic visit women will once again complete the OAB-q SF and PGI-I.
|
Continuous, Then Cycling
Women will be randomized to the continuing or cycling arm at 0 months. At 3 months, women will report for their second postoperative visit. Prior to this visit, study subjects will complete the third 3-day voiding diary and record pad usage. At the visit, women will complete the OAB-q SF as well as the PGI-I, and will be queried regarding any complications since the start of the use of their modulator. At the 3 month visit, women who were assigned to continuous stimulation will be switched to cycling stimulation and women who were assigned to cycling stimulation will be switched to continuous stimulation. Women again will report for clinical follow-up at six months. Women will be asked to complete a fourth 3 day voiding diary. In addition, women will be asked to record any complications that they have had in the preceding 3 months. At this clinic visit women will once again complete the OAB-q SF and PGI-I.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cycling Versus Continuous Mode in Neuromodulator Programming
Baseline characteristics by cohort
| Measure |
Group A (Cycling, Then Continuous)
n=11 Participants
Sacral neuromodulator devices (implanted pulse generator) will be programmed to on-off cycles (on 16 seconds, off 8 seconds). This means the devices are not continuously on. Rather they are on a "cycling" program.
sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation.
The first intervention (cycling) occurred at baseline, and the second intervention occurred at 3 months (continuous).
|
Group B (Continuous, Then Cycling)
n=12 Participants
Sacral neuromodulator devices (implanted pulse generator) will be programmed to be on continuously. This means the devices are continuously on. They are on a "continuous" program.
sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation.
The first intervention (continuous) occurred at baseline, and the second intervention occurred at 3 months (cycling).
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.8 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
63.4 years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
66.5 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic Latina
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Three months after change in program from cycling to continuous or vice versa.Population: Two participants in group A and two participants in group B withdrew from the study prior to completion.
The Overactive Bladder Questionnaire (OAB-q) assesses symptom bother \& health-related quality of life (HRQL) for overactive bladder. The short form OAB-q SF, provides a quick assessment of symptom bother, consisting of a 6-item symptom bother scale. The questionnaire is on a 6 point scale, 1 indicates symptom is not bothersome (best outcome), 6 indicates symptom bothers the participant "a very great deal" (worst possible outcome). The majority of the participants were missing the HRQL portion of the questionnaire, so this portion of the questionnaire was not included in the analysis. These are the raw scores ranges for each question prior to being transformed. The possible scores for complete surveys range from 13 (if the participant marked "not bothersome" for all 6) to 78 (if the participant marked "a very great deal" for all 6 questions) once transformed. The reported numbers are the transformed scores \[(actual raw score-lowest possible score)/possible raw score range\] X 100.
Outcome measures
| Measure |
Cycling, Then Continuous
n=11 Participants
Sacral neuromodulator devices (implanted pulse generator) will be programmed to on-off cycles (on 16 seconds, off 8 seconds). This means the devices are not continuously on. Rather they are on a "cycling" program.
sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation.
|
Continuous, Then Cycling
n=12 Participants
Sacral neuromodulator devices (implanted pulse generator) will be programmed to be on continuously. This means the devices are continuously on. They are on a "continuous" program.
sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation.
|
|---|---|---|
|
Overactive Bladder Questionnaire-Short Form (OABq) Short Form Symptom Bother Scale Result
Baseline
|
68.3 units on a scale
Standard Deviation 22.3
|
66.3 units on a scale
Standard Deviation 27.0
|
|
Overactive Bladder Questionnaire-Short Form (OABq) Short Form Symptom Bother Scale Result
3 Months
|
30.3 units on a scale
Standard Deviation 20.7
|
38.0 units on a scale
Standard Deviation 22.0
|
|
Overactive Bladder Questionnaire-Short Form (OABq) Short Form Symptom Bother Scale Result
6 Months
|
24.7 units on a scale
Standard Deviation 20.7
|
53.3 units on a scale
Standard Deviation 27.0
|
SECONDARY outcome
Timeframe: Three months after change in program from cycling to continuous or vice versa.Population: 2 Participants from group A and two participants from group B withdrew from the study prior to completion.
Bladder Diaries (BD) are a useful clinical tool and one of the most common outcome measure used in studies of urinary incontinence and other forms of lower urinary tract dysfunction. The patient is asked to prospectively record the frequency, number and volume of voids and incontinence episodes. The National Institutes of Health (NIH) recommends diary duration of at least three days for research studies.
Outcome measures
| Measure |
Cycling, Then Continuous
n=11 Participants
Sacral neuromodulator devices (implanted pulse generator) will be programmed to on-off cycles (on 16 seconds, off 8 seconds). This means the devices are not continuously on. Rather they are on a "cycling" program.
sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation.
|
Continuous, Then Cycling
n=12 Participants
Sacral neuromodulator devices (implanted pulse generator) will be programmed to be on continuously. This means the devices are continuously on. They are on a "continuous" program.
sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation.
|
|---|---|---|
|
Voiding Diary: Urge Incontinence Episodes
Baseline
|
6.9 Number of leaks per day on 3 day diary
Standard Deviation 3.4
|
8.1 Number of leaks per day on 3 day diary
Standard Deviation 6.5
|
|
Voiding Diary: Urge Incontinence Episodes
Change to 3 Months
|
-1.3 Number of leaks per day on 3 day diary
Standard Deviation 4.5
|
-2.9 Number of leaks per day on 3 day diary
Standard Deviation 7.4
|
|
Voiding Diary: Urge Incontinence Episodes
Change to 6 Months
|
-.35 Number of leaks per day on 3 day diary
Standard Deviation 5.7
|
-2.5 Number of leaks per day on 3 day diary
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Three months after change in program from cycling to continuous or vice versa.Population: 2 Participants in group A and 2 participants in group B withdrew from the study prior to completion.
The Patient Global Impression of Improvement (PGI-I) scale is a global index that may be used to rate the response of a condition to a therapy. It is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a 7 point scale, 1 indicating the participant's condition is "Very much better" (best possible outcome), and 7 being "Very much worse" (worst possible outcome). The answers to the 7 questions were then averaged to a score.
Outcome measures
| Measure |
Cycling, Then Continuous
n=11 Participants
Sacral neuromodulator devices (implanted pulse generator) will be programmed to on-off cycles (on 16 seconds, off 8 seconds). This means the devices are not continuously on. Rather they are on a "cycling" program.
sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation.
|
Continuous, Then Cycling
n=12 Participants
Sacral neuromodulator devices (implanted pulse generator) will be programmed to be on continuously. This means the devices are continuously on. They are on a "continuous" program.
sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation.
|
|---|---|---|
|
Patient Global Impression of Improvement (PGI-I) Questionnaire Scale Results
3 Months
|
2.6 units on a scale
Standard Deviation 1.3
|
2.6 units on a scale
Standard Deviation .79
|
|
Patient Global Impression of Improvement (PGI-I) Questionnaire Scale Results
6 Months
|
2.5 units on a scale
Standard Deviation 1.5
|
2.7 units on a scale
Standard Deviation 1.7
|
Adverse Events
Arm 1: Cycling
Arm 2: Continuous
Serious adverse events
| Measure |
Arm 1: Cycling
n=23 participants at risk
Sacral neuromodulator devices (implanted pulse generator) will be programmed to on-off cycles (on 16 seconds, off 8 seconds). This means the devices are not continuously on. Rather they are on a "cycling" program.
sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation.
|
Arm 2: Continuous
n=23 participants at risk
Sacral neuromodulator devices (implanted pulse generator) will be programmed to be on continuously. This means the devices are continuously on. They are on a "continuous" program.
sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation.
|
|---|---|---|
|
Nervous system disorders
Seizure
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
Other adverse events
| Measure |
Arm 1: Cycling
n=23 participants at risk
Sacral neuromodulator devices (implanted pulse generator) will be programmed to on-off cycles (on 16 seconds, off 8 seconds). This means the devices are not continuously on. Rather they are on a "cycling" program.
sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation.
|
Arm 2: Continuous
n=23 participants at risk
Sacral neuromodulator devices (implanted pulse generator) will be programmed to be on continuously. This means the devices are continuously on. They are on a "continuous" program.
sacral neuromodulator: The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Falls
|
21.7%
5/23
|
17.4%
4/23
|
|
Infections and infestations
Current Urinary Tract Infection
|
4.3%
1/23
|
8.7%
2/23
|
|
Gastrointestinal disorders
Changes in bowel movements
|
8.7%
2/23
|
17.4%
4/23
|
|
Renal and urinary disorders
New Treatments for OAB
|
8.7%
2/23
|
4.3%
1/23
|
|
Renal and urinary disorders
Stopped medications for OAB
|
0.00%
0/23
|
8.7%
2/23
|
|
Surgical and medical procedures
Outpatient Surgery
|
8.7%
2/23
|
8.7%
2/23
|
Additional Information
Dr. Yuko Komesu, MD
University of New Mexico Health Sciences Center, Department of Obstetrics & Gynecology, Division of Urogynecology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place