Trial · NCT00904618
Safety and Efficacy Study on the Implantation of the Tension-Free Vaginal Tape (TVT-Secur) Under Local Anesthesia
NCT00904618, Phase 2, Completed, Université de Sherbrooke; results first posted 2009-05-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Study on the Implantation of the Tension-Free Vaginal Tape (TVT-Secur) Under Local Anesthesia. Trials, record NCT00904618. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00904618
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study on the Implantation of the Tension-Free Vaginal Tape (TVT-Secur) Under Local Anesthesia
- NCT number
- NCT00904618
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- Université de Sherbrooke
- Conditions
- Urinary Stress Incontinence
- Interventions
- 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%).
- First posted
- 2009-05-19
- Last updated
- 2009-05-19
- Results first posted
- 2009-05-19
- 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.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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'. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Local Anesthesia Satisfaction | Questionnaire filled 1 week after surgery | 2 patients did not fill out the questionnaire 1 week after surgery | participants | NUMBER |
| SECONDARY | Improvement in Stress Urinary Symptoms. | Six months | 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. | participants | NUMBER |
| SECONDARY | Safety of the Sling. | 15 months | 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'. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Local Anesthesia Satisfaction | TVT-SECUR | Yes | 43 | participants | |
| Local Anesthesia Satisfaction | TVT-SECUR | No | 3 | participants | |
| Improvement in Stress Urinary Symptoms. | 'Hammock' Technique | Improved | 11 | participants | |
| Improvement in Stress Urinary Symptoms. | U-Method | Improved | 22 | participants | |
| Improvement in Stress Urinary Symptoms. | 'Hammock' Technique | Not improved | 5 | participants | |
| Improvement in Stress Urinary Symptoms. | U-Method | Not improved | 0 | participants | |
| Safety of the Sling. | 'Hammock' Technique | Perioperative urethral laceration | 0 | Participants | |
| Safety of the Sling. | U-Method | Perioperative urethral laceration | 1 | Participants | |
| Safety of the Sling. | 'Hammock' Technique | Postoperative vaginal erosions | 6 | Participants | |
| Safety of the Sling. | U-Method | Postoperative vaginal erosions | 0 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TVT-SECUR | 48 | |
| Overall Study | COMPLETED | TVT-SECUR | 48 | |
| Overall Study | NOT COMPLETED | TVT-SECUR | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TVT-SECUR | ||
| Total, other adverse events | TVT-SECUR | ||
| Total, serious adverse events | TVT-SECUR |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00904618
GET https://conductscience.org/api/trials/v1/NCT00904618/registered