Transvaginal Mesh vs. Laparoscopic Colposacropexy- Study
ConditionProlapse, Vaginal Vault
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-99
SponsorHelsinki University Central Hospital
About this trial
The main objective of the study is to compare subjective efficacy of trans vaginal mesh and laparoscopic colposakropexy (CSP) in women with an apical prolapse. The CSP group is further divided into two sub-groups; one where the mesh fixation is only at the apical part of the vagina, and another where the fixation is also extended to the levator plane.
The secondary outcomes are safety (peri- and post-surgery complications, pain, erosion), objective efficacy (simplified POP-Q), and re-operation rate. Subjective outcome also includes the assessment of sexual satisfaction. Cost-effectiveness is studied by comparing both direct costs and QALYs.
Eligibility criteria
Qualifiers
Age over 18 years and capability to understand the study protocol either in Finnish or Swedish.
Objectively diagnosed symptomatic apical prolapse (leading apical prolapse (points C/D) ≥ -2) and a history of previous POP operation including hysterectomy.
No need for any other concomitant operations except colporrhaphies and possible prophylactic salpingo-oophorectomy in CSP groups
Disqualifiers
A history of serious or prolonged pain after any operation or current or previous prolonged (over 6 months) pain of any reason.
BMI over 40
Regular use of systemic corticosteroid medication.
Incapability to understand the study protocol.
Trial design
Treatments tested in this trial
- TVM
- Colposacropexy
Treatment groups
318 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov