Transvaginal mesh repair of recurrent vaginal prolaps (prolift technique); a cross sectional study of 65 cases in a Dutch teaching hospital.

Transvaginal mesh repair of recurrent vaginal prolaps (prolift technique); a cross sectional study of 65 cases in a Dutch teaching hospital. - Follow up study after meshimplantation for recurrent vaginal prolapse

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35178

Enrollment

Registered

2012-03-29

Start date

2012-05-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prolapse vaginal prolapse

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Women who underwent mesh implantation surgery for recurrent vaginal prolapse in Medisch Centrum Leeuwarden between April 2008 and April 2011.

Exclusion criteria

Exclusion criteria: -

Design outcomes

Primary

Measure	Time frame
Using the POP-Q test during gynecological examination the anatomical outcome will be assessed. These outcomes will be compared to those prior to the correction of the pelvic floor dysfunction.	—

Secondary

Measure	Time frame
- General quality of life will be assessed by using a standardized measurement (Rand-36). - Urinary and defecatory symptoms will be analyzed by using validated disease specific questionnaires concerning quality of life (Urogenital Disease Inventory, Defecation Distress Inventory and Incontinence Impact Questionnaire). - PISQ-12 translated to Dutch will be used to assess sexual functioning, where as some selected items from the Vragenlijst Seksuele Disfuncties will complement PISQ-12 questionnaire. - Satisfaction with outcome after surgery among the women will be assessed by asking them to answer the question if they are satisfied by the result of the surgical procedure. Multiple choice answers will be provided by the Likert Scale that ranges from very dissatisfied tot very satisfied in 5 points. For the analysis of these answers, we will dichotomize those answers and divide them in very dissatisfied/dissatisfied/moderately satisfied and satisfied/very satisfied. Remaining secondary endpoint is the time needed for complete recovery. The women will be asked after how many days, weeks or months they felt completely recovered after surgery. Likert Scale will also be used to range five different answers: within 2 weeks, 2-4 weeks, 1- months, 3-6 months and beyond 6 months. Dichotomizing these answers will also take place in this analysis, within 3 months and beyond 3 months.	—

Measure

Time frame

- General quality of life will be assessed by using a standardized measurement (Rand-36). - Urinary and defecatory symptoms will be analyzed by using validated disease specific questionnaires concerning quality of life (Urogenital Disease Inventory, Defecation Distress Inventory and Incontinence Impact Questionnaire). - PISQ-12 translated to Dutch will be used to assess sexual functioning, where as some selected items from the *Vragenlijst Seksuele Disfuncties* will complement PISQ-12 questionnaire. - Satisfaction with outcome after surgery among the women will be assessed by asking them to answer the question if they are satisfied by the result of the surgical procedure. Multiple choice answers will be provided by the Likert Scale that ranges from very dissatisfied tot very satisfied in 5 points. For the analysis of these answers, we will dichotomize those answers and divide them in very dissatisfied/dissatisfied/moderately satisfied and satisfied/very satisfied. Remaining secondary endpoint is the time needed for complete recovery. The women will be asked after how many days, weeks or months they felt completely recovered after surgery. Likert Scale will also be used to range five different answers: within 2 weeks, 2-4 weeks, 1- months, 3-6 months and beyond 6 months. Dichotomizing these answers will also take place in this analysis, within 3 months and beyond 3 months.

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Countries

Netherlands

Outcome results