NCT04478747|Recruiting
Transvaginal Mesh vs. Laparoscopic Colposacropexy- Study
TVM vs LCSP
Women's Apical Pelvic Organ Prolapse Treatment - a Randomized Controlled Trial Comparing Transvaginal and Laparoscopic Mesh Surgery
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TVM vs LCSP
Women's Apical Pelvic Organ Prolapse Treatment - a Randomized Controlled Trial Comparing Transvaginal and Laparoscopic Mesh Surgery
Sponsor study identifier
interventional
318
1 country
1
Study Start
July 1, 2020
Actual (reported)Primary Completion
December 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 15, 2020
Actual (reported)July 1, 2020
Actual (reported)July 21, 2020
Actual (reported)December 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Subjective success; defined as the absence of vaginal bulge
Negative response to PDFI-20, question 3, at one-year following the surgery
5 years
Peri and post-operative complications
1 year
Post-operative pain
1 year
Objective efficacy
1 year
Re-operation rate
1 year
Cost-effectiveness
1 year
BSC mesh (A.M.I., Feldkirch, Austria) is attached to the sacrospinosus ligaments and to the apical part of the vagina.
EndoGYNious (A.M.I.) CSP mesh is attached laparoscopically to the apical part of the vagina.
EndoGYNious (A.M.I.) CSP mesh is attached laparoscopically to the apical part of the vagina with fixation reaching to the level of the levator planes.
Transvaginal mesh operation using BSC mesh (A.M.I., Feldkirch, Austria)
Colposacropexy using EndoGYNious mesh (A.M.I., Feldkirch, Austria)
Helsinki Naistenklinikka
Helsinki, Finland
First Submitted
June 15, 2020
First Posted
July 21, 2020
Study Start
July 1, 2020
Actual (reported)Primary Completion
December 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Prospective Study for Vaginal Vault Prolapse After Hysterectomy: Comparison of Two Surgical Methods
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Study Completion
December 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 24, 2025
Record last verified: 2025-09
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Source: ClinicalTrials.gov.
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