Vaginal Packing Following Laparoscopic SacrocolpopexyNCT02943525
Vaginal Packing After Laparoscopic Sacrocolpopexy
A study testing vaginal packing in people with Vaginal Packing Following Laparoscopic Sacrocolpopexy and Pelvic Organ Prolapse, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
Vaginal packing is used routinely following vaginal reconstructive surgery, however, no recommendation regarding vaginal packing after laparoscopic sacrocolpopexy exists. Despite little data to support the practice, purported benefits better positioning and fixation of the mesh, improving incorporation of the mesh by… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Packing Following Laparoscopic Sacrocolpopexy, Pelvic Organ Prolapse
- What is being tested?
- vaginal packing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 1 siteCzechia
- Study dates
- 14 Nov 2016to 2 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Laparoscopic sacrocolpopexy without a suburethral sling
- Pelvic organ prolapse stage > 2
- Speak and read Czech
- Can to understand the informed consent
Who cannot join
- Any other surgery than sacrocolpopexy
- Concurrent hysterectomy or opening of the vagina during the surgery.
- Vaginal, uterine, cervical or ovarian malignancy
- Clotting disorder, taking anticoagulation
- Having intraoperative blood loss greater than 500 ml
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Department of Obstetrics and Gynecology, Charles University Hospital
Pilsen, 30460
About this study
Official title: Vaginal Packing After Laparoscopic Sacrocolpopexy; Patient Pain and Satisfaction in Short Follow-up and Surgery Outcome and Complications in One Year Follow-up
Vaginal packing is used routinely following vaginal reconstructive surgery, however, no recommendation regarding vaginal packing after laparoscopic sacrocolpopexy exists. Despite little data to support the practice, purported benefits better positioning and fixation of the mesh, improving incorporation of the mesh by its fixation and reduced blood loss. Patients often complain of discomfort associated with the packing or its removal. The aim of this randomized controlled is to compare the subjective impressions of pain and bother in women undergoing laparoscopic sacrocolpopexy treated with and without packing. The investigators also aim to assess differences in postoperative bacteriuria, urine retention and hemoglobin levels on day 5 after the surgery and surgery outcome and complications at one year after the surgery in those with and without packing.
- Being tested
- vaginal packing
- Keywords
- vaginal packing, pelvic organ prolapse, pain and satisfaction
- Medical subject headings
- Pelvic Organ Prolapse, Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal packingProcedure or surgery
Packing vagina with a Boric acid soaked gauze at the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| packing | Experimental | Patients after laparoscopic sacrocolpopexy with a vaginal packing at the end of surgery Receives: Procedure: vaginal packing |
| no packing | No intervention | Patients after laparoscopic sacrocolpopexy without a vaginal packing at the end of surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain assessed using VAS
Visual analog scale (VAS)
Measured: The first post-operative day before extraction of the packing
Satisfaction with the overall postoperative course assessed using VAS
VAS
Measured: Postoperative day 5
Prolapse recurrence
Pelvic Organ Prolapse Quantification System (POP-Q) classification - the most descending compartment >-1cm from hymen
Measured: 1 year after the surgery
Surgery related complications
According to the International Continence Society / International UroGynecology Association Joint Terminology and Classification Report of the complications related directly to the insertion of prostheses (meshes, implants, tapes) \& grafts in female pelvic floor surgery
Measured: From the surgery until 1 year after the surgery
Postoperative pain assessed using the McGill Questionnaire
McGill Questionnaire
Measured: The first post-operative day before extraction of the packing
Secondary outcomes (3)
Number of analgesics used
Measured: From the end of the surgery until the first postoperative day
Positive urine culture
Measured: Postoperative day 5
Satisfaction with surgery assessed using VAS
VAS
Measured: Postoperative day 1 before packing extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study start14 Nov 2016
- Primary completion1 Jun 2022
- Study completion2 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Vaginal Packing Following Laparoscopic SacrocolpopexyStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zdenek Rusavy, Charles University, Czech Republic
- Investigators
- Zdenek Rusavy, MD PhD, Principal investigator, Medical Faculty in Pilsen, Charles University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943525
- Sponsor's protocol ID
- PACKING
- Status last verified
- Mar 2026
- First submitted
- 21 Oct 2016
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Thiagamoorthy G, Khalil A, Cardozo L, Srikrishna S, Leslie G, Robinson D. The value of vaginal packing in pelvic floor surgery: a randomised double-blind study. Int Urogynecol J. 2014 May;25(5):585-91. doi: 10.1007/s00192-013-2264-y. Epub 2013 Dec 6.
PubMed 24310987Westermann LB, Crisp CC, Oakley SH, Mazloomdoost D, Kleeman SD, Benbouajili JM, Ghodsi V, Pauls RN. To Pack or Not to Pack? A Randomized Trial of Vaginal Packing After Vaginal Reconstructive Surgery. Female Pelvic Med Reconstr Surg. 2016 Mar-Apr;22(2):111-7. doi: 10.1097/SPV.0000000000000238.
PubMed 26825408Rusavy Z, Marinic Veverkova A, Smazinka M, Kalis V. Vaginal packing after laparoscopic sacrocolpopexy - postoperative pain and satisfaction: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2026 Jan;316:114815. doi: 10.1016/j.ejogrb.2025.114815. Epub 2025 Nov 5.
PubMed 41202691Rusavy Z, Marinic Veverkova A, Smazinka M, Kalis V. Vaginal packing after laparoscopic sacrocolpopexy and surgical outcome after one year: A randomized controlled trial. Acta Obstet Gynecol Scand. 2025 Dec;104(12):2331-2338. doi: 10.1111/aogs.70067. Epub 2025 Oct 10.
PubMed 41070594
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Packing After Laparoscopic Sacrocolpopexy; Patient Pain and Satisfaction in Short Follow-up and Surgery Outcome and Complications in One Year Follow-up
- ClinicalTrials.gov ID
- NCT02943525
- Acronym / sponsor ID
- PACKING
- Keywords
- vaginal packing, pelvic organ prolapse, pain and satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 14 Nov 2016 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 2 Jul 2023 (actual)
- First posted
- 24 Oct 2016 (estimated)
- 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.
Vaginal packing is used routinely following vaginal reconstructive surgery, however, no recommendation regarding vaginal packing after laparoscopic sacrocolpopexy exists. Despite little data to support the practice, purported benefits better positioning and fixation of the mesh, improving incorporation of the mesh by its fixation and reduced blood loss. Patients often complain of discomfort associated with the packing or its removal. The aim of this randomized controlled is to compare the subjective impressions of pain and bother in women undergoing laparoscopic sacrocolpopexy treated with and without packing. The investigators also aim to assess differences in postoperative bacteriuria, urine retention and hemoglobin levels on day 5 after the surgery and surgery outcome and complications at one year after the surgery in those with and without packing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| packing | Experimental | Procedure: vaginal packingPatients after laparoscopic sacrocolpopexy with a vaginal packing at the end of surgery |
| no packing | No intervention | –Patients after laparoscopic sacrocolpopexy without a vaginal packing at the end of surgery |
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)
- Laparoscopic sacrocolpopexy without a suburethral sling
- Pelvic organ prolapse stage > 2
- Speak and read Czech
- Can to understand the informed consent
Key exclusion criteria (5 listed)
- Any other surgery than sacrocolpopexy
- Concurrent hysterectomy or opening of the vagina during the surgery.
- Vaginal, uterine, cervical or ovarian malignancy
- Clotting disorder, taking anticoagulation
- Having intraoperative blood loss greater than 500 ml
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 |
|---|---|---|
| vaginal packingPacking vagina with a Boric acid soaked gauze at the end of surgery | Procedure or surgery | packing |
Primary outcome
Postoperative pain assessed using VAS
Time frame: The first post-operative day before extraction of the packing
Visual analog scale (VAS)
Satisfaction with the overall postoperative course assessed using VAS
Time frame: Postoperative day 5
VAS
Prolapse recurrence
Time frame: 1 year after the surgery
Pelvic Organ Prolapse Quantification System (POP-Q) classification - the most descending compartment >-1cm from hymen
Surgery related complications
Time frame: From the surgery until 1 year after the surgery
According to the International Continence Society / International UroGynecology Association Joint Terminology and Classification Report of the complications related directly to the insertion of prostheses (meshes, implants, tapes) \& grafts in female pelvic floor surgery
Postoperative pain assessed using the McGill Questionnaire
Time frame: The first post-operative day before extraction of the packing
McGill Questionnaire
3 secondary outcomes
Number of analgesics used
Time frame: From the end of the surgery until the first postoperative day
Positive urine culture
Time frame: Postoperative day 5
Satisfaction with surgery assessed using VAS
Time frame: Postoperative day 1 before packing extraction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 24310987Thiagamoorthy G, Khalil A, Cardozo L, Srikrishna S, Leslie G, Robinson D. The value of vaginal packing in pelvic floor surgery: a randomised double-blind study. Int Urogynecol J. 2014 May;25(5):585-91. doi: 10.1007/s00192-013-2264-y. Epub 2013 Dec 6.
- Background: PubMed 26825408Westermann LB, Crisp CC, Oakley SH, Mazloomdoost D, Kleeman SD, Benbouajili JM, Ghodsi V, Pauls RN. To Pack or Not to Pack? A Randomized Trial of Vaginal Packing After Vaginal Reconstructive Surgery. Female Pelvic Med Reconstr Surg. 2016 Mar-Apr;22(2):111-7. doi: 10.1097/SPV.0000000000000238.
- Derived from this study: PubMed 41202691Rusavy Z, Marinic Veverkova A, Smazinka M, Kalis V. Vaginal packing after laparoscopic sacrocolpopexy - postoperative pain and satisfaction: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2026 Jan;316:114815. doi: 10.1016/j.ejogrb.2025.114815. Epub 2025 Nov 5.
- Derived from this study: PubMed 41070594Rusavy Z, Marinic Veverkova A, Smazinka M, Kalis V. Vaginal packing after laparoscopic sacrocolpopexy and surgical outcome after one year: A randomized controlled trial. Acta Obstet Gynecol Scand. 2025 Dec;104(12):2331-2338. doi: 10.1111/aogs.70067. Epub 2025 Oct 10.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Zdenek Rusavy, MD PhD principal investigator
Medical Faculty in Pilsen, Charles University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vaginal packing in people with Vaginal Packing Following Laparoscopic Sacrocolpopexy and Pelvic Organ Prolapse, run by Charles University, Czech Republic at 1 site in Czechia.
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 5 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: finished, as of the sponsor's last update on 19 Mar 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 Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain assessed using VAS (time frame: The first post-operative day before extraction of the packing). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02943525, which also lists 4 linked publications.
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 19 Mar 2026.