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Transvaginal meshes (TVM) are indicated for the treatment of pelvic organ prolapse (POP) where surgical intervention is necessary. Due to a potential risk of de novo dyspareunia, TVM are mainly used in postmenopausal women and in case of recurrent POP. PROLIFT+M (Trademark) is based on a highly flexible material which is partially absorbable. We suggest that PROLIFT+M has less impact on the vita sexualis than conventional TVM and could also be used for the treatment of younger and/or sexually active women. This study observes women who are routinely treated with PROLIFT+M with regard to their sexual function before and after the surgery. The hypothesis is that there is no worsening in vita sexualis with PROLIFT+M.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROLIFT+M | Patients that undergo surgery due to prolapse POP ≥ stage II with PROLIFT+M device having had ≥ 2x/4 weeks sexual intercourse before surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| vita sexualis | No worsening in vita sexualis (decrease in total score Female Sexual Function Index (FSFI-d) of ≤ 3.3; max. score = 36) measured at 12 months (+/- 1 month) postoperatively as compared to the preoperative score. | 7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| pain during sexual intercourse | No worsening in pain during sexual intercourse (decrease in weighted pain subscore FSFI-d of ≤ 1; max score = 6) measured at 12 months (+/- 1 month) postoperatively compared to preoperative. | 7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative |
| Assessment of pelvic floor function |
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Inclusion Criteria:
Exclusion Criteria:
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Patients visiting specialist in hospitals and specialized doctor's offices scheduled to undergo Prolapse surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Tanja Hülder, Dr.med. | Cantonal Hospital of St. Gallen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Augsburg | Augsburg | Bavaria | 86156 | Germany | ||
| Universitätsklinikum des Saarlandes |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Assessment of pelvic floor function using the validated German pelvic floor questionnaire at 12 months (+/- 1 month) postoperatively compared to preoperative (Deutscher Beckenboden-Fragebogen, validated German Version of the Australian Pelvic Floor Questionnaire |
| 7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative |
| Assessment of patient satisfaction | Assessment of patient satisfaction at 12 months (+/- 1 month) postoperatively using the visual analogue scale (VAS), question regarding reoperation and patient global (PGI) question.VAS: On top of two scales, the question "How satisfied are you with the result of your operation?" is placed. (Facial expressions are put above the line to express satisfaction visually). In addition, the following two questions are asked: "Would you have the operation done again?" and "In the past 12 months how would you rate your condition as opposed to before your recent pelvic floor operation: much better/a little better/about the same/a little worse/much worse" (PGI question). | 12 months (+/- 1 month) Postoperative |
| Assessment of recurrent POP (POP-Q ≥ stage II) | Assessment of recurrent POP (POP-Q ≥ stage II in the operated compartment(s)), mesh erosion/exposure; each measured 3 (12 +/- 2 weeks) and 12 months (+/- 1 month) postoperatively by clinical examination (Speculum, palpation, POP-Q) | 3 months (12 weeks +/- 2) and 12 months (+/- 1 month) postoperatively |
| Safety | Safety (documentation and assessment of medical device incidents; serious incidents and near incidents will be reported to the competent authorities) | until 12 months (+/- 1 month) postoperatively |
| Homburg/Saar |
| Saarland |
| 66424 |
| Germany |
| DRK Krankenhaus Chemnitz-Rabenstein | Chemnitz | Saxony | 09117 | Germany |
| Kantonsspital St.Gallen | Sankt Gallen | St.Gallen | 9007 | Switzerland |