Trial Outcomes & Findings for InterStim® Sacral Nerve Modulation Cycling Study (NCT NCT01957137)

Results Overview

Urinary urge incontinent episodes were collected through a diary on daily basis for approximately 4 weeks when subjects were under each cycling setting. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

4 weeks

Results posted on

2017-12-12

Participant Flow

Thirty subjects were enrolled into the study from Sept 10, 2013 through May 22, 2015 from 3 US centers.

Participant milestones

Participant milestones
Measure	All Study Participants Thirty subjects were randomized to 1 of 24 sequences with 4 cycling settings: 2 subjects discontinued early with 1 due to an AE, and 1 due to consent withdrawal. Twenty-eight subjects completed the randomization sequences . After that all subjects went through no stimulation for approximately 4 weeks, which was not part of randomization.
Randomized Portion STARTED	30
Randomized Portion Continuous Stimulation	29
Randomized Portion Cycling Parameter #1	30
Randomized Portion Cycling Parameter #2	28
Randomized Portion Cycling Parameter #3	28
Randomized Portion COMPLETED	28
Randomized Portion NOT COMPLETED	2
No Stimulation STARTED	28
No Stimulation COMPLETED	28
No Stimulation NOT COMPLETED	0

Reasons for withdrawal

Reasons for withdrawal
Measure	All Study Participants Thirty subjects were randomized to 1 of 24 sequences with 4 cycling settings: 2 subjects discontinued early with 1 due to an AE, and 1 due to consent withdrawal. Twenty-eight subjects completed the randomization sequences . After that all subjects went through no stimulation for approximately 4 weeks, which was not part of randomization.
Randomized Portion Adverse Event	1
Randomized Portion Withdrawal by Subject	1

Baseline Characteristics

InterStim® Sacral Nerve Modulation Cycling Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects Who First Finished Unique Randomization Sequences n=24 Participants Baseline descriptions provided were based on 24 subjects who first finished unique randomization sequences, which are those subjects included in the primary analysis of the primary outcome.
Age, Continuous	64.0 years STANDARD_DEVIATION 13.5 • n=93 Participants
Sex: Female, Male Female	24 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Years implanted with InterStim therapy	2.8 years STANDARD_DEVIATION 3.1 • n=93 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: 24 subjects who first completed the unique randomization sequences were included in the analysis.

Urinary urge incontinent episodes were collected through a diary on daily basis for approximately 4 weeks when subjects were under each cycling setting. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.

Outcome measures

Outcome measures
Measure	Continuous n=24 Participants Subjects received continuous stimulation for approximately 4 weeks.	Cycling Parameter #1 n=24 Participants Subjects received cycling parameter #1 for approximately 4 weeks.	Cycling Parameter #2 n=24 Participants Subjects received cycling parameter #2 for approximately 4 weeks.	Cycling Parameter #3 n=24 Participants Subjects received cycling parameter #3 for approximately 4 weeks.
Number of Urinary Urge Incontinent (UUI) Episodes Per Day - Randomized Portion	1.64 Number of UUI episodes/ Day Standard Deviation 1.40	1.82 Number of UUI episodes/ Day Standard Deviation 1.97	1.44 Number of UUI episodes/ Day Standard Deviation 1.20	1.76 Number of UUI episodes/ Day Standard Deviation 1.76

SECONDARY outcome

Timeframe: 4 week

Population: 24 subjects who first completed unique randomization sequences were included in the analysis.

Each UUI episode was rated on following scales: 0=None, 1=Mild, 2=Moderate, 3=Severe, which were collected through a diary on daily basis for approximately 4 weeks when subjects were under each cycling setting. The average degree of urgency per UUI episode was calculated from the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.

Outcome measures

Outcome measures
Measure	Continuous n=24 Participants Subjects received continuous stimulation for approximately 4 weeks.	Cycling Parameter #1 n=24 Participants Subjects received cycling parameter #1 for approximately 4 weeks.	Cycling Parameter #2 n=24 Participants Subjects received cycling parameter #2 for approximately 4 weeks.	Cycling Parameter #3 n=24 Participants Subjects received cycling parameter #3 for approximately 4 weeks.
Degree of Urgency - Randomized Portion	1.83 units on a scale Interval 1.48 to 2.19	1.80 units on a scale Interval 1.44 to 2.16	1.54 units on a scale Interval 1.17 to 1.91	1.65 units on a scale Interval 1.29 to 2.01

SECONDARY outcome

Timeframe: 4 weeks

Population: 24 subjects who first completed unique randomization sequences were included in the analysis.

Number of pad use were collected through a diary on daily basis for approximately 4 weeks when subjects were under each cycling setting. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.

Outcome measures

Outcome measures
Measure	Continuous n=24 Participants Subjects received continuous stimulation for approximately 4 weeks.	Cycling Parameter #1 n=24 Participants Subjects received cycling parameter #1 for approximately 4 weeks.	Cycling Parameter #2 n=24 Participants Subjects received cycling parameter #2 for approximately 4 weeks.	Cycling Parameter #3 n=24 Participants Subjects received cycling parameter #3 for approximately 4 weeks.
Number of Pads Used Per Day - Randomized Portion	1.10 Pads per day Interval 0.67 to 1.52	1.16 Pads per day Interval 0.73 to 1.58	1.17 Pads per day Interval 0.74 to 1.59	1.20 Pads per day Interval 0.78 to 1.63

SECONDARY outcome

Timeframe: 4 weeks

Population: 24 subjects who first completed unique randomization sequences were included in the analysis.

Summary statistics of GRA at different cycling settings are provided. The GRA assessed incontinence symptoms as compared to symptoms prior to subject's entry into the study. Subjects were asked how much their incontinence changed since starting the study: markedly worse, moderately worse, mildly worse, same, slightly improved, moderately improved, or markedly improved. The responses to the symptom change were categorized into three levels for the analysis: worse (markedly worse, moderately worse, mildly worse), same (same), better (slightly improved, moderately improved, or markedly improved). Percentages of subjects reported worse, same or better under each cycling setting since starting the study are presented.

Outcome measures

Outcome measures
Measure	Continuous n=24 Participants Subjects received continuous stimulation for approximately 4 weeks.	Cycling Parameter #1 n=24 Participants Subjects received cycling parameter #1 for approximately 4 weeks.	Cycling Parameter #2 n=24 Participants Subjects received cycling parameter #2 for approximately 4 weeks.	Cycling Parameter #3 n=24 Participants Subjects received cycling parameter #3 for approximately 4 weeks.
Global Response Assessment (GRA) - Randomized Portion Better	29 Percent of Subjects	38 Percent of Subjects	54 Percent of Subjects	42 Percent of Subjects
Global Response Assessment (GRA) - Randomized Portion Same	25 Percent of Subjects	21 Percent of Subjects	17 Percent of Subjects	38 Percent of Subjects
Global Response Assessment (GRA) - Randomized Portion Worse	46 Percent of Subjects	42 Percent of Subjects	29 Percent of Subjects	21 Percent of Subjects

SECONDARY outcome

Timeframe: 4 Weeks

Population: 28 subjects who received no stimulation were included in the analysis.

UUI episodes were collected through a diary on daily basis for approximately 4 weeks when subjects were under no stimulation. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.

Outcome measures

Outcome measures
Measure	Continuous n=28 Participants Subjects received continuous stimulation for approximately 4 weeks.	Cycling Parameter #1 Subjects received cycling parameter #1 for approximately 4 weeks.	Cycling Parameter #2 Subjects received cycling parameter #2 for approximately 4 weeks.	Cycling Parameter #3 Subjects received cycling parameter #3 for approximately 4 weeks.
Number of UUI Episodes Per Day - no Stimulation	1.97 Number of UUI episodes/ Day Standard Deviation 2.04	—	—	—

SECONDARY outcome

Timeframe: 4 weeks

Population: 28 subjects who received no stimulation were included in the analysis.

Each UUI episode was rated on following scales: 0=None, 1=Mild, 2=Moderate, 3=Severe, which were collected through a diary on daily basis for approximately 4 weeks when subjects were under no stimulation. The average degree of urgency per UUI episode was calculated from the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.

Outcome measures

Outcome measures
Measure	Continuous n=28 Participants Subjects received continuous stimulation for approximately 4 weeks.	Cycling Parameter #1 Subjects received cycling parameter #1 for approximately 4 weeks.	Cycling Parameter #2 Subjects received cycling parameter #2 for approximately 4 weeks.	Cycling Parameter #3 Subjects received cycling parameter #3 for approximately 4 weeks.
Degree of Urgency - no Stimulation	1.77 units on a scale Standard Deviation 0.64	—	—	—

SECONDARY outcome

Timeframe: 4 Weeks

Population: 28 subjects who received no stimulation were included in the analysis.

Number of pad use were collected through a diary on daily basis for approximately 4 weeks when subjects were under no stimulation. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.

Outcome measures

Outcome measures
Measure	Continuous n=28 Participants Subjects received continuous stimulation for approximately 4 weeks.	Cycling Parameter #1 Subjects received cycling parameter #1 for approximately 4 weeks.	Cycling Parameter #2 Subjects received cycling parameter #2 for approximately 4 weeks.	Cycling Parameter #3 Subjects received cycling parameter #3 for approximately 4 weeks.
Number of Pads Used Per Day - no Stimulation	1.23 Pad use / day Standard Deviation 1.22	—	—	—

SECONDARY outcome

Timeframe: 4 Weeks

Population: 28 subjects who received no stimulation were included in the analysis.

Summary of GRA under no stimulation setting is provided. The GRA assessed incontinence symptoms as compared to symptoms prior to subject's entry into the study. Subjects were asked how much their incontinence changed since starting the study: markedly worse, moderately worse, mildly worse, same, slightly improved, moderately improved, or markedly improved. The responses to the symptom change were categorized into three levels for the analysis: worse (markedly worse, moderately worse, mildly worse), same (same), better (slightly improved, moderately improved, or markedly improved).

Outcome measures

Outcome measures
Measure	Continuous n=28 Participants Subjects received continuous stimulation for approximately 4 weeks.	Cycling Parameter #1 Subjects received cycling parameter #1 for approximately 4 weeks.	Cycling Parameter #2 Subjects received cycling parameter #2 for approximately 4 weeks.	Cycling Parameter #3 Subjects received cycling parameter #3 for approximately 4 weeks.
Global Response Assessment - no Stimulation Better	43 Percent of Subjects	—	—	—
Global Response Assessment - no Stimulation Same	21 Percent of Subjects	—	—	—
Global Response Assessment - no Stimulation Worse	36 Percent of Subjects	—	—	—

SECONDARY outcome

Timeframe: 4 Weeks

Population: 28 subjects who received no stimulation were included in the analysis.

Summary of adverse device effects when subjects were under no stimulation is provided. Percentage of subjects experiencing any type of Adverse Device Effect under no stimulation is presented.