ProViS (Prolift+M and Vita Sexualis) Study

Dr. med. Tanja Hülder

Status: Completed

Conditions: Pelvic Organ Prolapse

Study type: Observational

Funder types: Other

Identifiers

NCT01997996

CTU 10/038

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

18 participants in 1 patient group

PROLIFT+M

Description:

Patients that undergo surgery due to prolapse POP ≥ stage II with PROLIFT+M device having had ≥ 2x/4 weeks sexual intercourse before surgery.