ProViS (Prolift+M and Vita Sexualis) Study

Study Overview
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Brief Summary
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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.

Official Title
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ProViS (Prolift+M TM and Vita Sexualis) Study

Conditions
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Pelvic Organ Prolapse

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient understands the nature and content of the trial POP ≥ stage II (according to the POP-Q system (18)) Sexual intercourse ≥ 2x/4 weeks Written informed consent Negative pregnancy test in women of childbearing potential Women ≥ 18 years Exclusion Criteria: Concomitant surgery at the inner genitalis (e.g. colporrhaphy, sacrocolpopexy, sacrospinous fixation, hysterectomy); concomitant suburethral slings and bulking agents are allowed Unable to read or speak German Women < 18 years Women who are pregnant or breastfeeding or planning future pregnancies Acute infection(s), e.g. untreated urogenital infections

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PROLIFT+M<br>Patients that undergo surgery due to prolapse POP ≥ stage II with PROLIFT+M device having had ≥ 2x/4 weeks sexual intercourse before surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic Organ Prolapse, PROLIFT+M, Vita sexualis