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

NCT ID: NCT00904618

Last Updated: 2009-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-03-31

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.

Conditions

Urinary Stress Incontinence

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

TVT-SECUR - 'Hammock' technique

Intervention Type: PROCEDURE

The surgery was done under local anesthesia by one high-volume surgeon. 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'.

TVT-SECUR - 'U-Method'

Intervention Type: PROCEDURE

The surgery was done under local anesthesia by one high-volume surgeon. 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'.

Local anesthesia (30 to 40 ml of a mixture of 35 ml of lidocaine 2% and 5 ml of bicarbonate 3%).

Intervention Type: DRUG

Local anesthesia consisted of 30 to 40 ml of a mixture of 35 ml of lidocaine 2% and 5 ml of bicarbonate 3%. Sedation was used in association with local anesthesia, including 1 mg of lorazepam sublingual as well as a combination of 0.5 to 2 mg intravenous (IV) of midazolam and 50 to 200 ug IV of fentanyl. Postoperative analgesia consisted of a prescription of 30 tablets of morphine 5 mg.

Interventions

TVT-SECUR - 'Hammock' technique

The surgery was done under local anesthesia by one high-volume surgeon. 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'.

Intervention Type: PROCEDURE

TVT-SECUR - 'U-Method'

The surgery was done under local anesthesia by one high-volume surgeon. 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'.

Intervention Type: PROCEDURE

Local anesthesia (30 to 40 ml of a mixture of 35 ml of lidocaine 2% and 5 ml of bicarbonate 3%).

Local anesthesia consisted of 30 to 40 ml of a mixture of 35 ml of lidocaine 2% and 5 ml of bicarbonate 3%. Sedation was used in association with local anesthesia, including 1 mg of lorazepam sublingual as well as a combination of 0.5 to 2 mg intravenous (IV) of midazolam and 50 to 200 ug IV of fentanyl. Postoperative analgesia consisted of a prescription of 30 tablets of morphine 5 mg.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ethicon, Inc.

INDUSTRY

Sponsor Role: collaborator

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Centre Hospitalier Universitaire de Sherbrooke

Principal Investigators

Le-Mai Tu, MD, MSc, FRCS

Role: PRINCIPAL_INVESTIGATOR

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Locations

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Countries

Canada

Other Identifiers

USherbrooke-001

Identifier Type: -

Identifier Source: org_study_id