NCT07612202

Brief 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.

Trial Health

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Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
30mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress1%
Jun 2026Dec 2028

First Submitted

Initial submission to the registry

May 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

June 3, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

May 21, 2026

Last Update Submit

May 21, 2026

Conditions

Postoperative CareProlapse GenitalUrogynecologic Surgery

Keywords

postoperativerandomised ccontrolled trialvaginal compressionprolapse surgery

Outcome Measures

Primary Outcomes (1)

  • Reccurence of prolapse 3 months postoperatively

    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.

    3-6 months

Secondary Outcomes (5)

  • Time to discharge

    48 hours

  • Postoperative voiding

    48 hours

  • Postoperative pain

    48 hours

  • Urinary tract infection

    3 months

  • Postoperative complications

    3-6 months

Study Arms (3)

Posterior colporrhaphy

ACTIVE COMPARATOR
Other: No postoperative vaginal compressionOther: Postoperative vaginal compression

Collum amputation/Manchester procedure

ACTIVE COMPARATOR
Other: No postoperative vaginal compressionOther: Postoperative vaginal compression

Anterior colporrhaphy

ACTIVE COMPARATOR
Other: No postoperative vaginal compressionOther: Postoperative vaginal compression

Interventions

No postoperative vaginal compressionOTHER

No vaginal compression through vaginal gauze packing after urogynecolocigal surgery

Anterior colporrhaphyCollum amputation/Manchester procedurePosterior colporrhaphy
Postoperative vaginal compressionOTHER

Postoperative vaginal compression through vaginal gauze packing after urogynecolocigal surger

Anterior colporrhaphyCollum amputation/Manchester procedurePosterior colporrhaphy

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gynecology-Obstetrics, Copenhagen University Hospital - North Zealand

Hillerød, Copenhagen, 3400, Denmark

Location

Study Officials

  • Christiane M. B. F. Gam, MD, PhD

    Departement og Gynecology-Obstetrics, Copenhagen University Hospital - North Zealand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christiane M. B. F. Gam, MD, PhD

CONTACT

00 45 48 29 73 99christiane.marie.bourgin.folke.gam@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Semi-masked as surgeon will only know 5 minutes before surgery ends whther patient has been randomized to intervention or not.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study includes 3 arms : 1) patients planned for anterior colporrhaphy 2) patients planned for posterior colporrhaphy and 3) patients planned for collum amputation/Manchester procedure. Each arm is randomized to either postoperative vaginal compression or the omission of it.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 21, 2026

First Posted

May 28, 2026

Study Start

June 3, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

May 28, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Permission not sought at ethical comittee.

Locations

DK(1)