NCT06744972

Brief Summary

This study evaluates the recurrence of pelvic organ prolapse and the rate of re-operation after primary surgery for anterior vaginal wall prolapse with native tissue repair in long term follow-up.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
392

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Longer than P75 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
Last Updated

December 20, 2024

Status Verified

December 1, 2024

Enrollment Period

9.6 years

First QC Date

December 17, 2024

Last Update Submit

December 17, 2024

Conditions

Pelvic Organ ProlapseCystocele

Keywords

RecurrenceNative tissue repair

Outcome Measures

Primary Outcomes (1)

  • Rate of re-operations

    Evaluate the risk of re-operation for pelvic organ prolapse and recurrence of surgically treated cystocele.

    Long-term, at least 5 years follow up.

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Female patients treated for cystocele for the first time with native tissue repair.

You may qualify if:

  • cystocele treated with native tissue surgery, medical records reaching until the end of follow-up period

You may not qualify if:

  • history of previous pelvic organ prolapse surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pelvic Organ ProlapseCystoceleRecurrence

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDisease AttributesPathologic Processes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, head of section, gynaecology

Study Record Dates

First Submitted

December 17, 2024

First Posted

December 20, 2024

Study Start

May 1, 2015

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

December 20, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share