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

This study has been completed.
Sponsor:
Collaborator:
Ethicon, Inc.
Information provided by:
Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT00904618
First received: March 11, 2009
Last updated: May 18, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Urinary Stress Incontinence
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%).
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Better Short-Term Outcomes With The 'U-Method' Compared to the 'Hammock' Technique for the Implantation of the TVT-SECUR Under Local Anesthesia

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Local Anesthesia Satisfaction [ Time Frame: Questionnaire filled 1 week after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in Stress Urinary Symptoms. [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Safety of the Sling. [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: January 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Procedure: 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'.
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'.
Drug: 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.

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of stress urinary incontinence or stress predominant mixed urinary incontinence
  • Acceptance of local anesthesia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904618

Locations
Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
Ethicon, Inc.
Investigators
Principal Investigator: Le-Mai Tu, MD, MSc, FRCS Centre Hospitalier Universitaire de Sherbrooke
  More Information

No publications provided

Responsible Party: Le-Mai Tu, Centre Hospitalier Universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT00904618     History of Changes
Other Study ID Numbers: USherbrooke-001
Study First Received: March 11, 2009
Results First Received: March 11, 2009
Last Updated: May 18, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Université de Sherbrooke:
Suburethral slings
Urethra
Urinary incontinence
Urinary stress incontinence

Additional relevant MeSH terms:
Urinary Incontinence, Stress
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Anesthetics
Lidocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014