Trial Outcomes & Findings for Modified Extension Study to the SUmiT Trial: Evaluation of Long Term Therapy With Percutaneous Tibial Nerve Stimulation (PTNS) for Overactive Bladder Symptoms (NCT NCT00928395)

Results Overview

The GRA asked patients, "Compared to the last time you completed this questionnaire, how would you rate your bladder symptoms now?" and was a 7-level Assessment (markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse, markedly worse).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

36 months total

Results posted on

2013-05-16

Participant Flow

Subjects were recruited by investigator sites.

Participant milestones

Participant milestones
Measure	Urgent PC The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
Overall Study STARTED	50
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Modified Extension Study to the SUmiT Trial: Evaluation of Long Term Therapy With Percutaneous Tibial Nerve Stimulation (PTNS) for Overactive Bladder Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Urgent PC n=50 Participants The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants
Age Continuous	60.5 years STANDARD_DEVIATION 15.5 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 36 months total

The GRA asked patients, "Compared to the last time you completed this questionnaire, how would you rate your bladder symptoms now?" and was a 7-level Assessment (markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse, markedly worse).

Outcome measures

Outcome measures
Measure	Urgent PC n=50 Participants The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
Proportion of Patients Reporting "Moderately" or "Markedly" Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline	.77 Proportion of Patients Interval 0.64 to 0.9

SECONDARY outcome

Timeframe: every three months for 36 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: every three months for 36 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: every three months for 36 months

Outcome measures

Outcome data not reported

Adverse Events

Urgent PC

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Urgent PC n=50 participants at risk The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
Surgical and medical procedures Bleeding at needle site	2.0% 1/50 • Number of events 2

Additional Information

Clinical Study Manager

Uroplasty, Inc

Phone: 952-426-6153

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place