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CompletedNCT06744972Updated Dec 20, 2024

Native Tissue Repair in Pelvic Organ Prolapse -Long-term Results and Risk of Re-operation

An observational study in Pelvic Organ Prolapse and Cystocele, sponsored by Turku University Hospital. Completed. Open to female participants. Per ClinicalTrials.gov, last updated 2024-12-20.

Sponsored by Turku University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
392
Sex
Female
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Study 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.

Read the detailed description

This was a retrospective cohort study including patients undergoing their first surgical intervention for pelvic organ prolapse in Turku University Hospital gynecology department in the years 2000-2005. The point of interest was to study patients with prolapse of the anterior vaginal compartment (i.e. cystocele) with native tissue repair surgical approach as treatment. We made a search from the medical database of surgical procedures for operation codes LEF00 (i.e.anterior colporraphy and LEF13 (i.e. vaginal hysterectomy of descended uterus with/without vaginal/perineal molding) during the studied period. Initially, we found 699 patients with matching operating codes and for those, we went through their medical records. From the final study population, we excluded those who had previously had an operation for pelvic organ prolapse and those whose primary operation didn't include anterior colporraphy and those who weren't eligible for long term follow-up. Thus, the study population constituted of 392 subjects who were followed through medical records until the end of October 2018.

From the medical records, we collected the day of birth, the date of the primary operation, body mass index, history of vaginal childbirth and cesarean section (if available), history of incontinence surgery, the grade of cystocele and diagnosis and before surgery, the operation code and executed surgical procedures, possible complications, and the history of possible re-operations. Also, the date of death was reported as well as the date of changing residence outside the Hospital District of Varsinais-Suomi.

All gathered information were saved without personal details.

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Conditions studied

  • Pelvic Organ Prolapse
  • Cystocele

Keywords

  • Recurrence
  • Native tissue repair
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In context

Cystocele

62 studies on the registry are indexed under Cystocele; 4 are open to participants now.

This study's enrollment of 392 is above the median of 300 across 19 observational studies indexed under Cystocele.

Browse Cystocele studies →

Lead sponsor

Turku University Hospital is the lead sponsor of 280 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • history of previous pelvic organ prolapse surgery
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
392 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Rate of re-operations

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

    Time frame: Long-term, at least 5 years follow up.

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06744972
Lead sponsor
Turku University Hospital
Responsible party
Pia Heinonen (MD, PhD, head of section, gynaecology, Turku University Hospital) — Principal investigator
First posted
Dec 20, 2024
Start date
May 2015
Primary completion
Dec 2024
Completion
Dec 2024
Last update
Dec 20, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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