Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • TVM

    Procedure/Surgery

    Transvaginal mesh operation using BSC mesh (A.M.I., Feldkirch, Austria)

  • Colposacropexy

    Procedure/Surgery

    Colposacropexy using EndoGYNious mesh (A.M.I., Feldkirch, Austria)

Treatment groups

318 Participants
are divided into 3 treatment groups
Group A: Transvaginal meshActive comparator 1 intervention
Group B: Colposacropexy with the apical fixation onlyActive comparator 1 intervention
Group C: Colposacropexy with the apical and the levator fixationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Subjective success; defined as the absence of vaginal bulge

Negative response to PDFI-20, question 3, at one-year following the surgery

Time frame
5 years

Secondary outcomes

1

Peri and post-operative complications

peri- and post-operative complications as recorded in medical charts

Time frame
1 year
2

Post-operative pain

Pain is evaluated by visual analogue scale (VAS; 0-10) scale

Time frame
1 year
3

Objective efficacy

simplified POP-Q

Time frame
1 year
4

Re-operation rate

re-operations

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Helsinki University Central Hospital

Lead sponsor

Source ClinicalTrials.gov
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