Trial Outcomes & Findings for TVT-SECUR as an Office-based Procedure (NCT NCT01137539)

Last Updated: 2017-06-28

Results Overview

Negative response to question #3 on the Urogenital Distress Inventory-6 (UDI-6) questionnaire. Question #3 states, "Do you currently experience urine leakage related to physical activity, coughing or sneezing." If a subject answers "No", this is considered success. If a subject answers "Yes", this is considered failure of treatment.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

24 months

Results posted on

2017-06-28

Participant Flow

Recruitment period: October 2008-May 2009 at medical practice

Participant milestones

Participant milestones
Measure	Gynecare TVT-SECUR System All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence Gynecare TVT-SECUR system: All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TVT-SECUR as an Office-based Procedure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gynecare TVT-SECUR System n=50 Participants All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence Gynecare TVT-SECUR system: All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=99 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants
Age, Continuous	46.7 years STANDARD_DEVIATION 8.8 • n=99 Participants
Sex: Female, Male Female	50 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Race/Ethnicity, Customized White	47 Participants n=99 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 Participants n=99 Participants
Region of Enrollment United States	50 participants n=99 Participants

PRIMARY outcome

Timeframe: 24 months

Population: 46 subjects were analyzed at the 24 month period out of the total 50 subjects enrolled in the study.

Outcome measures

Outcome measures
Measure	Gynecare TVT-SECUR System n=46 Participants All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence Gynecare TVT-SECUR system: All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence
Treatment Success Based on Patient Report on Validated Questionnaire	42 Participants

SECONDARY outcome

Timeframe: 12 months

Population: 49 subjects were analyzed at the 12 month period out of the total 50 subjects enrolled in the study.

Positive response to a satisfaction question

Outcome measures

Outcome measures
Measure	Gynecare TVT-SECUR System n=49 Participants All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence Gynecare TVT-SECUR system: All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence
Patient Satisfaction	47 Participants

Adverse Events

Gynecare TVT-SECUR System

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	Gynecare TVT-SECUR System n=50 participants at risk All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence Gynecare TVT-SECUR system: All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence
Product Issues Mesh Exposure	2.0% 1/50 • Adverse event data collected for 36 months following subject TVT-Secur procedure date.

Additional Information

Salil Khandwala/Medical Director

Michigan Institute of Women's Health

Phone: 313-982-0200

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place