NCT04478747

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
318

participants targeted

Target at P75+ for not_applicable

Timeline
80mo left

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Jul 2020Dec 2032

First Submitted

Initial submission to the registry

June 15, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
11.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2031

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2032

Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

11.4 years

First QC Date

June 15, 2020

Last Update Submit

September 19, 2025

Conditions

Prolapse, Vaginal Vault

Outcome Measures

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

    5 years

Secondary Outcomes (5)

  • 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

Study Arms (3)

Transvaginal mesh

ACTIVE COMPARATOR

BSC mesh (A.M.I., Feldkirch, Austria) is attached to the sacrospinosus ligaments and to the apical part of the vagina.

Procedure: TVM

Colposacropexy with the apical fixation only

ACTIVE COMPARATOR

EndoGYNious (A.M.I.) CSP mesh is attached laparoscopically to the apical part of the vagina.

Procedure: Colposacropexy

Colposacropexy with the apical and the levator fixation

ACTIVE COMPARATOR

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.

Procedure: Colposacropexy

Interventions

TVMPROCEDURE

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

Transvaginal mesh
ColposacropexyPROCEDURE

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

Colposacropexy with the apical and the levator fixationColposacropexy with the apical fixation only

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki Naistenklinikka

Helsinki, Finland

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Tomi Mikkola, Prof.

CONTACT

+358504271187tomi.mikkola@hus.fi

Camilla Isaksson, MD

CONTACT

camilla.isaksson@hus.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior consultant

Study Record Dates

First Submitted

June 15, 2020

First Posted

July 21, 2020

Study Start

July 1, 2020

Primary Completion (Estimated)

December 1, 2031

Study Completion (Estimated)

December 1, 2032

Last Updated

September 24, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)