Advertisement

Topics

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

2014-08-27 03:22:02 | BioPortfolio

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.

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.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Urinary Stress Incontinence

Intervention

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

Location

Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke
Quebec
Canada
J1H 5N4

Status

Completed

Source

Universitaire de Sherbrooke

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:22:02-0400

Clinical Trials [2167 Associated Clinical Trials listed on BioPortfolio]

TVT-SECUR as an Office-based Procedure

This is a pilot study to assess the feasibility and success of performing the TVT-Secur in the office setting. Endpoints would be success, complications, and patient and physician acceptan...

Secur-Fit Advanced Outcomes Study

This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Secur-Fit Advanced Hip Stem for primary total hip arthroplasty with a cementle...

TVT-SECUR A Pilot Study for the Treatment of Stress Urinary Incontinence

The primary objective of this study is to obtain clinical performance information on the GYNECARE TVT-SECUR* System (Tension-free Support for Incontinence) in women with stress urinary inc...

Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI)

This is a prospective, non-randomized, observational, multicentre (5 sites) study in which subjects that have surgically-correctable Stress Urinary Incontinence undergo a TVT SECUR operati...

Transvaginal Tape (TVT) Secur Versus TVT Randomised Controlled Trial (RCT)

This randomized multi-centre trial will recruit women with stress urinary incontinence who need surgical treatment for their condition. 300 women will be allocated either to receive a TVT...

PubMed Articles [17237 Associated PubMed Articles listed on BioPortfolio]

Facelift Performed Safely Under Local Anesthesia With Oral Sedation: Analysis of 174 Patients.

Anesthesia for elective ambulatory procedures must provide appropriate pain control while minimizing perioperative risk. Local anesthesia in combination with oral sedation provides a safe office-based...

Sub-muscular Breast Augmentation Using Tumescent Local Anesthesia.

Tumescent local anesthesia (TLA) consists of infiltration of saline solution with lidocaine and epinephrine into the tissues to obtain regional anesthesia and vasoconstriction. The use of TLA in augme...

Possibilities of thermographic rating the level of microcirculation with local anesthesia in dentistry.

It is known that the reduction of blood vessels by epinephrine that are part of the local anesthetic leads to a decrease in oxygen intake and the development of hypoxia, which has a significant effect...

A modification to Schneiderian membrane perforation repair technique: The Hammock Approach.

Schneiderian membrane perforation is one of the most common intra-surgical complications occurring during maxillary sinus elevation procedures. The management of these perforations is essential to acc...

Conscious sedation during subcutaneous implantable cardioverter-defibrillator implantation using the intermuscular technique.

The subcutaneous implantable cardioverter-defibrillator (S-ICD) system is an established therapy for the prevention of sudden cardiac death (SCD) and an alternative to a transvenous implantable cardio...

Medical and Biotech [MESH] Definitions

A local anesthetic of the amide type now generally used for surface anesthesia. It is one of the most potent and toxic of the long-acting local anesthetics and its parenteral use is restricted to spinal anesthesia. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1006)

A technique using a pneumatic, high-pressure stream of aluminum oxide to remove DENTAL ENAMEL; DENTIN; and restorative materials from teeth. In contrast to using DENTAL HIGH-SPEED EQUIPMENT, this method usually requires no dental anesthesia (ANESTHESIA, DENTAL) and reduces risks of tooth chipping and microfracturing. It is used primarily for routine DENTAL CAVITY PREPARATION.

Test for tissue antigen using either a direct method, by conjugation of antibody with fluorescent dye (FLUORESCENT ANTIBODY TECHNIQUE, DIRECT) or an indirect method, by formation of antigen-antibody complex which is then labeled with fluorescein-conjugated anti-immunoglobulin antibody (FLUORESCENT ANTIBODY TECHNIQUE, INDIRECT). The tissue is then examined by fluorescence microscopy.

A mass spectrometric technique that is used for the analysis of large biomolecules. Analyte molecules are embedded in an excess matrix of small organic molecules that show a high resonant absorption at the laser wavelength used. The matrix absorbs the laser energy, thus inducing a soft disintegration of the sample-matrix mixture into free (gas phase) matrix and analyte molecules and molecular ions. In general, only molecular ions of the analyte molecules are produced, and almost no fragmentation occurs. This makes the method well suited for molecular weight determinations and mixture analysis.

Procedure in which an anesthetic such as a gas or mixture of gases is inhaled through a tube into the lungs.

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

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Anesthesiology
An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...

Stress
Stress is caused by your perception of situations around you and then the reaction of your body to them. The automatic stress response to unexpected events is known as 'fight or flight'. Discovered by Walter Cannon in 1932, it is the release of h...


Searches Linking to this Trial