Trial Outcomes & Findings for Trial of Continuous Versus Cyclic Stimulation in Interstim Therapy (NCT NCT00928499)

NCT ID: NCT00928499

Last Updated: 2021-10-06

Results Overview

Collected in the 3 day voiding diary depending on their primary diagnosis

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 32 participants
• Primary outcome timeframe: After 4 weeks of stimulation a 3-day consecutive voiding diary was completed
• Results posted on: 2021-10-06

Participant Flow

Medical clinic over the course of 2 years

No participants were excluded.

Participant milestones

Measure	Continuous Stimulation First, Then Cyclic Stimulation Continuous stimulation first, then cyclic stimulation Interstim (SNS) : Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy	Cyclic Stimulation First, Then Continuous Stimulation Cyclic stimulation first, then continuous stimulation Interstim (SNS) : Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy
Overall Study STARTED	18	14
Overall Study COMPLETED	18	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of Continuous Versus Cyclic Stimulation in Interstim Therapy

Baseline characteristics by cohort

Measure	Interstim - Continuous Stimulation First, Then Cyclic Stimulation n=18 Participants Continuous stimulation Interstim (SNS) : Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy	Interstim - Cyclic Stimulation First, Then Continuous Stimulation n=14 Participants Cyclic stimulation Interstim (SNS) : Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Age, Continuous	65.6 years STANDARD_DEVIATION 12.3 • n=5 Participants	63.4 years STANDARD_DEVIATION 10.8 • n=7 Participants	64.6 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	14 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	14 participants n=7 Participants	32 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Collected in the 3 day voiding diary depending on their primary diagnosis

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Collected in the 3 day voiding diary depending on their primary diagnosis

Outcome measures

Outcome data not reported

Adverse Events

Interstim - Continuous, Then Cyclic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Interstim - Cyclic, Then Continuous

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Karen Noblett, MD

University of California, Irvine

Phone: 714-456-8564

Email: knoblett@uci.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place