ProViS (Prolift+M TM and Vita Sexualis) Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 4
- Primary Endpoint
- vita sexualis
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
vita sexualis
Time Frame: 7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative
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.
Secondary Outcomes
- Assessment of pelvic floor function(7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative)
- Assessment of patient satisfaction(12 months (+/- 1 month) Postoperative)
- pain during sexual intercourse(7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative)
- Assessment of recurrent POP (POP-Q ≥ stage II)(3 months (12 weeks +/- 2) and 12 months (+/- 1 month) postoperatively)
- Safety(until 12 months (+/- 1 month) postoperatively)
Investigators
Dr. med. Tanja Hülder
Dr. med. Tanja Hülder
Cantonal Hospital of St. Gallen