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The purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence: TVT and TVT-O.
Urinary stress incontinence (USI) is a frequent pathology in women. Surgical treatment is required in 30 to 50% of women presenting with USI. Several surgical techniques are currently available.
At the present time, the placement of suburethral slings is one of the most efficient techniques. Furthermore, the placement of a suburethral sling is known to be associated with a low rate of complications.
Currently, two approaches are available for the placement of a suburethral sling: retropubic approach (TVT) and trans-obturator approach (TVT-O). The efficacy of these two approaches seem equivalents. However, the morbidity related to these two techniques is probably different. In retrospective studies, the retropubic approach is associated with a higher rate of bladder perforation. On the other hand, the trans-obturator approach is supposed to be associated with a higher rate of post-operative pain.
Thus, the purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence: TVT and TVT-O.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surgical placement of a suburethral sling tvt or tvt-o | Device |
| Measure | Description | Time Frame |
|---|---|---|
| pre operative complication: rate of bladder perforation | ||
| post operative complication: rate of post-operative pain |
| Measure | Description | Time Frame |
|---|---|---|
| efficacy: disparation of urinary incontinence | ||
| safety: sexual behaviour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xavier Deffieux, MD | Hopital Antoine Beclere, Clamart, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Amiens | 80000 | France | |||
| Centre Hospitalier Universitaire |
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| Angers |
| 49000 |
| France |
| CHU Pellegrin | Bordeaux | 33000 | France |
| Hopital Saint Andre | Bordeaux | 33000 | France |
| CH Chambery | Chambéry | 73000 | France |
| Hopital Antoine Beclere | Clamart | 92140 | France |
| Hôtel Dieu | Clermont-Ferrand | 63058 | France |
| CH Dunkerque | Dunkirk | 59000 | France |
| Centre Hospitalier Paul Ardier | Issoire | 63500 | France |
| Chu Nancy | Nancy | France |
| CH Caremeau | Nîmes | 30000 | France |
| Hopital Diaconesses Croix Saint Simon | Paris | 75012 | France |
| CH Rennes | Rennes | 35000 | France |
| CH Rouen | Rouen | 76000 | France |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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