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Starting soon Not applicable

Postoperative Vaginal Compression After Prolapse Surgery - an RCT

NCT07612202 · tracked via the Priya Life Science Denmark tracker
Sponsor
Christiane Marie Bourgin Folke Gam
Phase
Not applicable
Started
2026-06-03
Last updated
2026-05-28

Condition(s) studied

Postoperative CareProlapse GenitalUrogynecologic Surgery

Investigational drug(s) / intervention(s)

No postoperative vaginal compressionPostoperative vaginal compression

No postoperative vaginal compression: No vaginal compression through vaginal gauze packing after urogynecolocigal surgery

Postoperative vaginal compression: Postoperative vaginal compression through vaginal gauze packing after urogynecolocigal surger

Study summary

The goal of this clinical trial is to learn if omitting postoperative vaginal compression (packing) can facilitate a more efficient recovery after elective surgery for uterovaginal prolapse. The main questions it aims to answer are: Will the omission of vaginal compression result in a non-inferior (unchanged) rate of prolapse recurrence within the first three months after surgery? Does the omission of vaginal compression lead to a shorter hospital stay and a faster return of normal bladder function? Researchers will compare a group that receives no postoperative vaginal compression to a control group that receives standard vaginal gauze packing for two hours to see if skipping the packing leads to shorter hospital stays and faster bladder emptying without increasing the risk of the prolapse returning.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria: * Planned anterior colporrhaphy, posterior colporrhaphy, or cervical amputation at the day surgery department, Nordsjællands Hospital, Capital Region, Denmark * Age 18 years and older . Cognitively capable patient * Received information material as described in the protocol Exclusion criteria: * Failure to pause blood-thinning medication on the day of surgery, if this was planned * Failure to discontinue regular intake of fish oil or ginger extract four weeks prior to the procedure * Immunosuppressed patients * Planned perineorrhaphy * Surgery involving more than two compartments * Non-Danish speaking patients

Primary outcome measure(s)

  • Reccurence of prolapse 3 months postoperatively — 3-6 months
    Prolapse recurrence within the first 3 months postoperatively, defined as one of the following: new treatment for prolapse (pessary or surgery), or prolapse grade 3 or greater, or prolapse grade 2 with concurrent prolapse symptoms.

Trial sites (1)

FacilityCityRegionStatus
Department of Gynecology-Obstetrics, Copenhagen University Hospital - North Zealand Hillerød Copenhagen
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07612202 on ClinicalTrials.gov ↗ ← All trials in Denmark