Postoperative Vaginal Compression After Prolapse Surgery - an RCT

NCT07612202 — Not applicable, Not yet recruiting, 360 participants, Christiane Marie Bourgin Folke Gam

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A Randomized Controlled Trial on Postoperative Vaginal Compression After Prolapse Surgery

Registry	NCT07612202
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, supportive care
Enrollment	360 (Estimated)
Sponsor	Christiane Marie Bourgin Folke Gam (Other); collaborators: Nordsjaellands Hospital
Conditions	Postoperative Care, Prolapse Genital, Urogynecologic Surgery
Interventions	No postoperative vaginal compression, Postoperative vaginal compression (Other)
Dates	start 2026-06-03 (estimated), primary completion 2028-06-01 (estimated), completion 2028-12-01 (estimated), first posted 2026-05-28, last updated 2026-05-28
Locations	1 site in Denmark

-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.

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+Arms and interventions

Arm	Type	Interventions
Posterior colporrhaphy	Active comparator	Other: No postoperative vaginal compression; Other: Postoperative vaginal compression
Collum amputation/Manchester procedure	Active comparator	Other: No postoperative vaginal compression; Other: Postoperative vaginal compression
Anterior colporrhaphy	Active comparator	Other: No postoperative vaginal compression; Other: Postoperative vaginal compression

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

+Outcome measures

Primary outcomes

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.

Secondary outcomes

Time to discharge [48 hours]: Postoperative hospitalization time, defined as the time from the completion of the surgical procedure until the patient is cleared for discharge.
Postoperative voiding [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.
Postoperative pain [48 hours]: Measured once per hour until discharge by visual analog scale score.
Urinary tract infection [3 months]: UTI measured by self-reporting or prescription issuance.
Postoperative complications [3-6 months]: Postoperative outpatient contacts due to a complication or suspicion of a postoperative complication.

+Eligibility

Sex: Female, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Department of Gynecology-Obstetrics, Copenhagen University Hospital - North Zealand	Hillerød, Copenhagen	Denmark

+Investigators

Christiane M. B. F. Gam, MD, PhD, Principal investigator, Departement og Gynecology-Obstetrics, Copenhagen University Hospital - North Zealand