Trial Outcomes & Findings for Study of Urgent PC Versus Sham Effectiveness in Treatment of Overactive Bladder Symptoms (NCT NCT00771264)

Last Updated: 2012-04-18

Results Overview

A responder was defined as reporting bladder symptoms as moderately or markedly improved on a 7-level GRA at week 13 after completing 12, 30-minute, consecutive weekly intervention sessions.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

220 participants

Primary outcome timeframe

13 weeks

Results posted on

2012-04-18

Participant Flow

Subjects were recruited by investigator sites with limited advertising

Participant milestones

Participant milestones
Measure	Urgent PC	Sham / Placebo
Overall Study STARTED	110	110
Overall Study COMPLETED	103	105
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Urgent PC Versus Sham Effectiveness in Treatment of Overactive Bladder Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Urgent PC n=110 Participants	Sham / Placebo n=110 Participants	Total n=220 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	54 Participants n=5 Participants	64 Participants n=7 Participants	118 Participants n=5 Participants
Age, Categorical >=65 years	56 Participants n=5 Participants	46 Participants n=7 Participants	102 Participants n=5 Participants
Age Continuous	62.5 years STANDARD_DEVIATION 14.6 • n=5 Participants	60.2 years STANDARD_DEVIATION 15.2 • n=7 Participants	61.3 years STANDARD_DEVIATION 14.9 • n=5 Participants
Sex: Female, Male Female	86 Participants n=5 Participants	88 Participants n=7 Participants	174 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants
Region of Enrollment United States	110 participants n=5 Participants	110 participants n=7 Participants	220 participants n=5 Participants

PRIMARY outcome

Timeframe: 13 weeks

Population: Intent to treat

A responder was defined as reporting bladder symptoms as moderately or markedly improved on a 7-level GRA at week 13 after completing 12, 30-minute, consecutive weekly intervention sessions.

Outcome measures

Outcome measures
Measure	Urgent PC n=110 Participants	Sham / Placebo n=110 Participants
The Global Response Assessment (GRA) for Overall Bladder Symptoms to Compare the Proportion of Subjects Reporting "Moderately" or "Markedly Improved" Responses on the GRA After 12 Interventions of Randomized Therapy, in an Intent to Treat Analysis.	60 participants	23 participants

Adverse Events

Urgent PC

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Sham / Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Urgent PC n=110 participants at risk	Sham / Placebo n=110 participants at risk
Surgical and medical procedures ankle bruising	0.91% 1/110 • Number of events 1	0.00% 0/110
Surgical and medical procedures discomfort at needle site	1.8% 2/110 • Number of events 2	0.00% 0/110
Surgical and medical procedures bleeding at needle site	2.7% 3/110 • Number of events 5	0.00% 0/110
Surgical and medical procedures tingling in leg	0.91% 1/110 • Number of events 1	0.00% 0/110

Additional Information

Susan Holman, Cheif Operating Officer

Uroplasty, Inc.

Phone: 952-426-6143

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place