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

• Sponsor: Université de Sherbrooke (Other)
• Overall Status: Completed
• CT.gov ID: NCT00904618
• Collaborator: Ethicon, Inc. (Industry)
• Enrollment: 48
• Location: 1
• Arm: 1
• Duration (Months): 26
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	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

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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'.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Clinical diagnosis of stress urinary incontinence or stress predominant mixed urinary incontinence

• Acceptance of local anesthesia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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 de recherche du Centre hospitalier universitaire de Sherbrooke

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00904618
• Other Study ID Numbers: USherbrooke-001
• First Posted: May 19, 2009
• Last Update Posted: May 19, 2009
• Last Verified: Apr 1, 2009

• Keywords provided by , ,: Suburethral slings; Urethra; Urinary incontinence; Urinary stress incontinence
• Additional relevant MeSH terms: Urinary Incontinence, Stress; Lidocaine

Study Results

Participant Flow

Recruitment Details	January 2007 to October 2008 at Centre Hospitalier Universitaire de Sherbrooke (CHUS)

Arm/Group Title	TVT-SECUR
Arm/Group Description	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.
Period Title: Overall Study
STARTED	48
COMPLETED	48
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	TVT-SECUR
Arm/Group Description	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.
Overall Participants	48
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	30 62.5%
>=65 years	18 37.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58 (11)
Sex: Female, Male (Count of Participants)
Female	48 100%
Male	0 0%
Region of Enrollment (participants) [Number]
Canada	48 100%

Outcome Measures

1. Primary Outcome

Title	Local Anesthesia Satisfaction
Description	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).
Time Frame	Questionnaire filled 1 week after surgery

Outcome Measure Data

Analysis Population Description

2 patients did not fill out the questionnaire 1 week after surgery

Arm/Group Title	TVT-SECUR
Arm/Group Description	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.
Measure Participants	46
Yes	43 89.6%
No	3 6.3%

2. Secondary Outcome

Title	Improvement in Stress Urinary Symptoms.
Description	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.
Time Frame	Six months

Outcome Measure Data

Analysis Population Description

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. Seven patients for the 'Hammock' technique and three patients for the 'U-Method' did not fill out the questionnaire at six months.

Arm/Group Title	'Hammock' Technique	U-Method
Arm/Group Description	The 'Hammock' technique is similar to the transobturator tape dissection.	The U-Method is similar to the retropubic tape dissection
Measure Participants	16	22
Improved	11 22.9%	22 NaN
Not improved	5 10.4%	0 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	TVT-SECUR, U-Method
	Comments	The test applies to the number of participants improved.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0087
	Comments
	Method	Fisher Exact
	Comments

3. Secondary Outcome

Title	Safety of the Sling.
Description	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'.
Time Frame	15 months

Outcome Measure Data

Analysis Population Description

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'.

Arm/Group Title	'Hammock' Technique	U-Method
Arm/Group Description	The 'Hammock' technique is similar to the transobturator tape dissection.	The 'U-Method' is similar to the retropubic tape dissection.
Measure Participants	25	23
Perioperative urethral laceration	0 0%	1 NaN
Postoperative vaginal erosions	6 12.5%	0 NaN
Postoperative transient urinary retention	0 0%	2 NaN

Adverse Events

Arm/Group Title	TVT-SECUR
Arm/Group Description	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.

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.