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

Phase 2

Completed

Conditions: Urinary Stress Incontinence

Interventions: Procedure: TVT-SECUR - 'Hammock' technique
Procedure: TVT-SECUR - 'U-Method'
Drug: Local anesthesia (30 to 40 ml of a mixture of 35 ml of lidocaine 2% and 5 ml of bicarbonate 3%).

Registration Number: NCT00904618

Lead Sponsor: Université de Sherbrooke

Brief Summary: The objective was to observe the satisfaction of local anesthesia during the implantation of the TVT-SECUR for the treatment of stress urinary incontinence, with the use of questionnaires completed by the patients, and to evaluate the short-term efficacy and safety of the sling, with a comparison of the two techniques of implantation: the 'U-Method' and the 'Hammock' technique.

Detailed Description: Stress urinary incontinence (SUI) is a common problem, affecting women of all ages. Treatment options for SUI include physiotherapy and surgical interventions, such as retropubic operations and midurethral slings. Conventional retropubic and transobturator tapes are the preferred choice for most surgeons, because of their wide applicability, technical simplicity and clinical efficacy. The retropubic tape has been effective for many years, but exposes the patients to serious complications, such as bladder perforations, principally because of the use of the retropubic space for the fixation of the tape. In an attempt to avoid the retropubic space, the second generation of slings, the transobturator tape, was introduced. However, prolonged postoperative groin pain as well as vascular injuries have been reported.

The last generation of midurethral slings, the tension-free vaginal tape system (TVT-SecurTM, Gynecare, Ethicon, Somerville, NJ, USA), introduced in 2005, attempts to lower the number of complications, by involving only a small vaginal incision and no exit wound. This 8-cm long laser-cut polypropylene mesh can potentially be implanted under local anesthesia, because of a less-invasive technique using minimal vaginal dissection as well as avoidance of retropubic space and obturator fossa. In the case of conventional midurethral slings, even if their implantation under local anesthesia has been studied and proven relatively safe, this practice has not gained popularity.

This was a prospective, clinical study with primary objective to observe the satisfaction of local anesthesia during the implantation of the TVT-SECUR, with the use of questionnaires completed by the patients. The secondary objective was to observe the short-term efficacy and safety of the sling. The final objective was to compare the two techniques of implantation: the 'U-Method' and the 'Hammock' technique.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 48

Inclusion Criteria

Clinical diagnosis of stress urinary incontinence or stress predominant mixed urinary incontinence
Acceptance of local anesthesia

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TVT-SECUR	TVT-SECUR - 'Hammock' technique	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.
TVT-SECUR	TVT-SECUR - 'U-Method'	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.
TVT-SECUR	Local anesthesia (30 to 40 ml of a mixture of 35 ml of lidocaine 2% and 5 ml of bicarbonate 3%).	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.

Primary Outcome Measures

Name	Time	Method
Local Anesthesia Satisfaction	Questionnaire filled 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).

Secondary Outcome Measures

Name	Time	Method
Improvement in Stress Urinary Symptoms.	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.
Safety of the Sling.	15 months	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'.