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

NCT00904618 | Completed Phase 2 Results

• 1 other identifier: USherbrooke-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Stress Incontinence

Keywords

Suburethral slings; Urethra; Urinary incontinence; Urinary stress incontinence

Outcome Measures

Primary Outcomes (1)

• Local Anesthesia Satisfaction

  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).

  Questionnaire filled 1 week after surgery

Secondary Outcomes (2)

• Improvement in Stress Urinary Symptoms.

  Six months

• Safety of the Sling.

  15 months

Study Arms (1)

TVT-SECUR

EXPERIMENTAL

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; 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%).

Interventions

TVT-SECUR - 'Hammock' technique 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

TVT-SECUR - 'U-Method' 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

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

TVT-SECUR

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Ethicon, Inc.: collaborator

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence

Interventions

Anesthesia, Local; Lidocaine

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

The single-surgeon single-center experience and the lack of objective outcome evaluation. A measurement bias of the 'U-Method' because of a learning curve for the cases using the 'Hammock' technique.

Results Point of Contact

• Title: Louis-Olivier Gagnon
• Organization: Centre Hospitalier Universitaire de Sherbrooke

louis.olivier.gagnon@gmail.com

1-819-437-4965

Study Officials

• Le-Mai Tu, MD, MSc, FRCS

  Centre de recherche du Centre hospitalier universitaire de Sherbrooke

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 11, 2009
• First Posted: May 19, 2009
• Study Start: January 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: May 19, 2009
• Results First Posted: May 19, 2009

Record last verified: 2009-04

Locations

CA (1)