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NCT Number: NCT07612202

Postoperative Vaginal Compression After Prolapse Surgery - an RCT

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.

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Key information

Conditions

Postoperative Care Prolapse Genital Urogynecologic Surgery

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Hillerød, Copenhagen, 3400, Denmark

Location contact

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

CONTACT

[email protected]

00 45 48 29 73 99

Louise Rosenius, Department Secretary

CONTACT

00 45 48 29 37 07

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No postoperative vaginal compression

Other

No vaginal compression through vaginal gauze packing after urogynecolocigal surgery

Postoperative vaginal compression

Other

Postoperative vaginal compression through vaginal gauze packing after urogynecolocigal surger

Primary outcomes

  1. Reccurence of prolapse 3 months postoperatively

    Time frame: 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.

Secondary outcomes

  1. Time to discharge

    Time frame: 48 hours

    Postoperative hospitalization time, defined as the time from the completion of the surgical procedure until the patient is cleared for discharge.

  2. Postoperative voiding

    Time frame: 48 hours

    Number of voidings, voided volume and residual urine volume (measured by abdominal ultrasound scan). Time to first normal voiding, defines as residual urine volume < 150 ml by ultrasound when voiding twice that volume.

  3. Postoperative pain

    Time frame: 48 hours

    Measured once per hour until discharge by visual analog scale score.

  4. Urinary tract infection

    Time frame: 3 months

    UTI measured by self-reporting or prescription issuance.

  5. Postoperative complications

    Time frame: 3-6 months

    Postoperative outpatient contacts due to a complication or suspicion of a postoperative complication.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

00 45 48 29 73 99

Sponsors and collaborators

Lead sponsor

Christiane Marie Bourgin Folke Gam

Other

Collaborators

  • Nordsjaellands Hospital

Registry information

Official study title

A Randomized Controlled Trial on Postoperative Vaginal Compression After Prolapse Surgery

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 28, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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