Trial Outcomes & Findings for Safety and Efficacy Study on the Implantation of the Tension-Free Vaginal Tape (TVT-Secur) Under Local Anesthesia (NCT NCT00904618)

Results Overview

Local anesthesia satisfaction was assessed with a questionnaire completed by the patients. The patients were asked if they would recommend this type of anesthesia (yes or no).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

48 participants

Primary outcome timeframe

Questionnaire filled 1 week after surgery

Results posted on

2009-05-19

Participant Flow

January 2007 to October 2008 at Centre Hospitalier Universitaire de Sherbrooke (CHUS)

Participant milestones

Participant milestones
Measure	TVT-SECUR This study arm consisted of 48 women operated from January 2007 to October 2008. All patients underwent the implantation of the TVT-SECUR for the treatment of stress urinary incontinence or stress predominant mixed urinary incontinence. The surgery was done under local anesthesia by one high-volume surgeon.
Overall Study STARTED	48
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy Study on the Implantation of the Tension-Free Vaginal Tape (TVT-Secur) Under Local Anesthesia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TVT-SECUR n=48 Participants This study arm consisted of 48 women operated from January 2007 to October 2008. All patients underwent the implantation of the TVT-SECUR for the treatment of stress urinary incontinence or stress predominant mixed urinary incontinence. The surgery was done under local anesthesia by one high-volume surgeon.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants
Age Continuous	58 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Canada	48 participants n=5 Participants

PRIMARY outcome

Timeframe: Questionnaire filled 1 week after surgery

Population: 2 patients did not fill out the questionnaire 1 week after surgery

Local anesthesia satisfaction was assessed with a questionnaire completed by the patients. The patients were asked if they would recommend this type of anesthesia (yes or no).

Outcome measures

Outcome measures
Measure	TVT-SECUR n=46 Participants This study arm consisted of 48 women operated from January 2007 to October 2008. All patients underwent the implantation of the TVT-SECUR for the treatment of stress urinary incontinence or stress predominant mixed urinary incontinence. The surgery was done under local anesthesia by one high-volume surgeon.	U-Method The U-Method is similar to the retropubic tape dissection
Local Anesthesia Satisfaction Yes	43 participants	—
Local Anesthesia Satisfaction No	3 participants	—

SECONDARY outcome

Timeframe: Six months

Population: The 'Hammock' technique, similar to the transobturator tape dissection, was used in the first 23 cases and the 'U-Method', similar to the retropubic tape dissection, in the last 25 cases. Seven patients for the 'Hammock' technique and three patients for the 'U-Method' did not fill out the questionnaire at six months.

A questionnaire with a Likert scale from one to five was used to assess the improvement in stress urinary symptoms at six months for each technique, the 'Hammock' technique and the 'U-Method' (1-Worst, 2-Same, 3-Improved, 4-Almost cured, 5-Cured). Patients had to answer 3 or more on the scale to be considered improved.

Outcome measures

Outcome measures
Measure	TVT-SECUR n=16 Participants This study arm consisted of 48 women operated from January 2007 to October 2008. All patients underwent the implantation of the TVT-SECUR for the treatment of stress urinary incontinence or stress predominant mixed urinary incontinence. The surgery was done under local anesthesia by one high-volume surgeon.	U-Method n=22 Participants The U-Method is similar to the retropubic tape dissection
Improvement in Stress Urinary Symptoms. Improved	11 participants	22 participants
Improvement in Stress Urinary Symptoms. Not improved	5 participants	0 participants

SECONDARY outcome

Timeframe: 15 months

Population: The 'Hammock' technique, similar to the transobturator tape dissection, was used in the first 23 cases and the 'U-Method', similar to the retropubic tape dissection, in the last 25 cases. Interim analysis performed after 23 cases led us to change the technique to the 'U-Method'.

Safety of the sling was assessed with a record of perioperative and postoperative complications. The following are all the complications experienced with the TVT-SECUR for each technique, the 'Hammock' technique and the 'U-Method'.

Outcome measures

Outcome measures
Measure	TVT-SECUR n=25 Participants This study arm consisted of 48 women operated from January 2007 to October 2008. All patients underwent the implantation of the TVT-SECUR for the treatment of stress urinary incontinence or stress predominant mixed urinary incontinence. The surgery was done under local anesthesia by one high-volume surgeon.	U-Method n=23 Participants The U-Method is similar to the retropubic tape dissection
Safety of the Sling. Perioperative urethral laceration	0 Participants	1 Participants
Safety of the Sling. Postoperative vaginal erosions	6 Participants	0 Participants
Safety of the Sling. Postoperative transient urinary retention	0 Participants	2 Participants

Adverse Events

TVT-SECUR

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

Louis-Olivier Gagnon

Centre Hospitalier Universitaire de Sherbrooke

Phone: 1-819-437-4965

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place