Urinary Stress Incontinence
Conditions
Keywords
Suburethral slings, Urethra, Urinary incontinence, Urinary stress incontinence
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.
Interventions
PROCEDURETVT-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'.
PROCEDURETVT-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'.
DRUGLocal 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.
Sponsors
Ethicon, Inc.
Université de Sherbrooke
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of stress urinary incontinence or stress predominant mixed urinary incontinence * Acceptance of local anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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'. |
Countries
Canada
Participant flow
Recruitment details
January 2007 to October 2008 at Centre Hospitalier Universitaire de Sherbrooke (CHUS)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 48 |
| Total | 48 |
Baseline characteristics
| Characteristic | TVT-SECUR |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 18 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age Continuous | 58 years STANDARD_DEVIATION 11 |
| Region of Enrollment Canada | 48 participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | — / — |
| serious Total, serious adverse events | — / — |
Outcome results
Primary
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).
Time frame: Questionnaire filled 1 week after surgery
Population: 2 patients did not fill out the questionnaire 1 week after surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TVT-SECUR | Local Anesthesia Satisfaction | Yes | 43 participants |
| TVT-SECUR | Local Anesthesia Satisfaction | No | 3 participants |
Secondary
Improvement in Stress Urinary Symptoms.
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TVT-SECUR | Improvement in Stress Urinary Symptoms. | Improved | 11 participants |
| TVT-SECUR | Improvement in Stress Urinary Symptoms. | Not improved | 5 participants |
| U-Method | Improvement in Stress Urinary Symptoms. | Improved | 22 participants |
| U-Method | Improvement in Stress Urinary Symptoms. | Not improved | 0 participants |
Comparison: The test applies to the number of participants improved.p-value: 0.0087Fisher Exact
Secondary
Safety of the Sling.
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TVT-SECUR | Safety of the Sling. | Perioperative urethral laceration | 0 Participants |
| TVT-SECUR | Safety of the Sling. | Postoperative vaginal erosions | 6 Participants |
| TVT-SECUR | Safety of the Sling. | Postoperative transient urinary retention | 0 Participants |
| U-Method | Safety of the Sling. | Perioperative urethral laceration | 1 Participants |
| U-Method | Safety of the Sling. | Postoperative vaginal erosions | 0 Participants |
| U-Method | Safety of the Sling. | Postoperative transient urinary retention | 2 Participants |