Clinical trial NCT01997996: ProViS (Prolift+M and Vita Sexualis) Study
Official title: ProViS (Prolift+M TM and Vita Sexualis) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Keywords: Pelvic Organ Prolapse
PROLIFT+M
Vita sexualis
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients visiting specialist in hospitals and specialized doctor's offices scheduled to undergo Prolapse surgery.

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.


Eligibility criteria: 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

Primary outcomes:
measure: vita sexualis
timeFrame: 7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative
Secondary outcomes:
measure: pain during sexual intercourse
timeFrame: 7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative
measure: Assessment of pelvic floor function
timeFrame: 7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative
measure: Assessment of patient satisfaction
timeFrame: 12 months (+/- 1 month) Postoperative
measure: Assessment of recurrent POP (POP-Q ≥ stage II)
timeFrame: 3 months (12 weeks +/- 2) and 12 months (+/- 1 month) postoperatively
measure: Safety
timeFrame: until 12 months (+/- 1 month) postoperatively
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Klinikum Augsburg
state: Bayern
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes
state: Saarland
city: Chemnitz
country: Germany
facility: DRK Krankenhaus Chemnitz-Rabenstein
state: Sachsen
city: St.Gallen
country: Switzerland
facility: Kantonsspital St.Gallen
Study officials:
affiliation: Cantonal Hospital of St. Gallen
name: Tanja Hülder, Dr.med.
role: STUDY_CHAIR
References: