Postoperative Vaginal Compression After Prolapse Surgery - an RCT

A Randomized Controlled Trial on Postoperative Vaginal Compression After Prolapse Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Care; Prolapse Genital; Urogynecologic Surgery
• Intervention / Treatment: Other: No postoperative vaginal compression; Other: Postoperative vaginal compression

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christiane M. B. F. Gam, MD, PhD; Phone Number: 00 45 48 29 73 99; Email: christiane.marie.bourgin.folke.gam@regionh.dk

Study Locations

• Denmark
  • Copenhagen
    • Hillerød, Copenhagen, Denmark, 3400
      • Department of Gynecology-Obstetrics, Copenhagen University Hospital - North Zealand
      • Contact: Christiane M. B. F. Gam, MD, PhD; Phone Number: 00 45 48 29 73 99; Email: christiane.marie.bourgin.folke.gam@regionh.dk
      • Contact: Louise Rosenius, Department Secretary; Phone Number: 00 45 48 29 37 07

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Posterior colporrhaphy	Other: No postoperative vaginal compression; No vaginal compression through vaginal gauze packing after urogynecolocigal surgery; Other: Postoperative vaginal compression; Postoperative vaginal compression through vaginal gauze packing after urogynecolocigal surger
Active Comparator: Collum amputation/Manchester procedure	Other: No postoperative vaginal compression; No vaginal compression through vaginal gauze packing after urogynecolocigal surgery; Other: Postoperative vaginal compression; Postoperative vaginal compression through vaginal gauze packing after urogynecolocigal surger
Active Comparator: Anterior colporrhaphy	Other: No postoperative vaginal compression; No vaginal compression through vaginal gauze packing after urogynecolocigal surgery; Other: Postoperative vaginal compression; Postoperative vaginal compression through vaginal gauze packing after urogynecolocigal surger

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Christiane Marie Bourgin Folke Gam
• Collaborators: Nordsjaellands Hospital
• Investigators: Principal Investigator: Christiane M. B. F. Gam, MD, PhD, Departement og Gynecology-Obstetrics, Copenhagen University Hospital - North Zealand

Study record dates

Study Major Dates

• Study Start (Estimated): June 3, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: postoperative; randomised ccontrolled trial; prolapse surgery; vaginal compression
• Other Study ID Numbers: p-2026-21529; H-26002005 (Other Identifier: The Committees on Health Research Ethics in the Capital Region of Denmark)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Permission not sought at ethical comittee.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No