Postoperative CareNCT07612202
Postoperative Vaginal Compression After Prolapse Surgery - an RCT
A study testing No postoperative vaginal compression and Postoperative vaginal compression in people with Postoperative Care and Prolapse Genital, run by Christiane Marie Bourgin Folke Gam at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Care, Prolapse Genital, Urogynecologic Surgery
- What is being tested?
- No postoperative vaginal compression and Postoperative vaginal compression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Jun 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Christiane M. B. F. Gam, MD, PhD contact
Denmark1 site
Department of Gynecology-Obstetrics, Copenhagen University Hospital - North Zealand
Hillerød, Copenhagen, 3400
Christiane M. B. F. Gam, MD, PhD, 00 45 48 29 73 99, christiane.marie.bourgin.folke.gam@regionh.dk
Louise Rosenius, Department Secretary, 00 45 48 29 37 07
About this study
Official title: 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.
- Conditions
- Postoperative Care, Prolapse Genital, Urogynecologic Surgery
- Being tested
- No postoperative vaginal compression, Postoperative vaginal compression
- Keywords
- postoperative, randomised ccontrolled trial, vaginal compression, prolapse surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No postoperative vaginal compressionOther
No vaginal compression through vaginal gauze packing after urogynecolocigal surgery
Postoperative vaginal compressionOther
Postoperative vaginal compression through vaginal gauze packing after urogynecolocigal surger
| Study group | Role | What they receive |
|---|---|---|
| Posterior colporrhaphy | Active comparator | Not described Receives: Other: No postoperative vaginal compression; Other: Postoperative vaginal compression |
| Collum amputation/Manchester procedure | Active comparator | Not described Receives: Other: No postoperative vaginal compression; Other: Postoperative vaginal compression |
| Anterior colporrhaphy | Active comparator | Not described Receives: Other: No postoperative vaginal compression; Other: Postoperative vaginal compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-6 months
Secondary outcomes (5)
Time to discharge
Postoperative hospitalization time, defined as the time from the completion of the surgical procedure until the patient is cleared for discharge.
Measured: 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.
Measured: 48 hours
Postoperative pain
Measured once per hour until discharge by visual analog scale score.
Measured: 48 hours
Urinary tract infection
UTI measured by self-reporting or prescription issuance.
Measured: 3 months
Postoperative complications
Postoperative outpatient contacts due to a complication or suspicion of a postoperative complication.
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start3 Jun 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christiane Marie Bourgin Folke Gam
- Sponsor type
- University, hospital or other
- Collaborators
- Nordsjaellands Hospital
- Responsible party
- Sponsor-investigator, Christiane Marie Bourgin Folke Gam, Nordsjaellands Hospital
- Investigators
- Christiane M. B. F. Gam, MD, PhD, Principal investigator, Departement og Gynecology-Obstetrics, Copenhagen University Hospital - North Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612202
- Sponsor's protocol ID
- p-2026-21529
- Other IDs
- H-26002005
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Permission not sought at ethical comittee.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on Postoperative Vaginal Compression After Prolapse Surgery
- ClinicalTrials.gov ID
- NCT07612202
- Acronym / sponsor ID
- p-2026-21529
- Conditions
- Postoperative Care, Prolapse Genital, Urogynecologic Surgery
- Keywords
- postoperative, randomised ccontrolled trial, vaginal compression, prolapse surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Christiane Marie Bourgin Folke GamUniversity, hospital or other
- Collaborators
- Nordsjaellands Hospital
- Study start
- 3 Jun 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No postoperative vaginal compressionNo vaginal compression through vaginal gauze packing after urogynecolocigal surgery | Other | Anterior colporrhaphy, Collum amputation/Manchester procedure, Posterior colporrhaphy |
| Postoperative vaginal compressionPostoperative vaginal compression through vaginal gauze packing after urogynecolocigal surger | Other | Anterior colporrhaphy, Collum amputation/Manchester procedure, Posterior colporrhaphy |
Primary outcome
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.
5 secondary outcomes
Time to discharge
Time frame: 48 hours
Postoperative voiding
Time frame: 48 hours
Postoperative pain
Time frame: 48 hours
Urinary tract infection
Time frame: 3 months
Postoperative complications
Time frame: 3-6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No. Permission not sought at ethical comittee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christiane M. B. F. Gam, MD, PhD contact
Christiane M. B. F. Gam, MD, PhD principal investigator
Departement og Gynecology-Obstetrics, Copenhagen University Hospital - North Zealand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No postoperative vaginal compression and Postoperative vaginal compression in people with Postoperative Care and Prolapse Genital, run by Christiane Marie Bourgin Folke Gam at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christiane M. B. F. Gam, MD, PhD (00 45 48 29 73 99, christiane.marie.bourgin.folke.gam@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reccurence of prolapse 3 months postoperatively (time frame: 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.