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It is unknown whether it is best to do the TVT( procedure for urinary stress incontinence in women) at the time of prolapse surgery or at a later date. Women with both conditions were randomized to both procedures together or the TVT 3 months after the prolapse surgery. Any or no leakage when couching was the main end-point, evaluated 1 year after the last surgery
All women were evaluated by the POP-Q (pelvic Organ Prolapse Quantification) prior to surgery and 1 year after.
Examination for urinary leakage was done prior to surgery and 1 year after. Group 2 was also examined after prolapse surgery to see if TVT was still needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Group I, Prolapse repair and TVT concomitantly |
|
| 2 | Active Comparator | Group II, Prolapse repair and TVT 3 months afterwards if necessary |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal Repair for prolapse, TVT procedure | Procedure |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Any or no leakage of urine when coughing | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The cure of urinary stress incontinence (USI) by only prolapse surgery | 1 year | |
| Result of prolapse surgery in two intervention strategies in women suffering from both genital prolapse and USI | 1 year |
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Inclusion Criteria: Pelvic Organ Prolapse that needs surgical repair and objectively proven urinary stress incontinence -
Exclusion Criteria: Not agreed to participate in randomization
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Borstad, MD | Michael Abdelnoor Phd, Department of epidemiology (same hospital) | Principal Investigator |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014549 | Urinary Incontinence |
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| TVT and Prolapse surgery | Procedure |
|
|
| 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 |