The value of vaginal packing in pelvic floor surgery: a randomised double-blind study
Abstract
Introduction and hypothesis The objective of this study was to evaluate the effect of vaginal packing following pelvic floor surgery with regard to post-operative pain, bleeding and infection. This was a double-blind randomised study of women undergoing vaginal hysterectomy and/or pelvic floor repair at a tertiary urogynaecology unit.Methods The primary outcome of day 1 post-operative pain was assessed using the short-form McGill Pain score. Secondary outcomes were haematological and infective morbidity, evaluated using changes in full blood count, and cultures of midstream urine and high vaginal swabs. A transvaginal ultrasound scan to exclude pelvic haematoma was performed at 6 weeks in all women who underwent vaginal hysterectomy with or without a pelvic floor repair.Results In total, 190 women were recruited: mean age 58.3 years (27-91 years), mean body mass index 27.4 kg/m(2) and median parity 3. Women were randomised into the 'pack' (n = 86) and 'no pack' (n = 87) arms with no demographic differences between the groups. No statistically significant differences in the post-operative pain scores or secondary outcome measures were demonstrated. Incidence of haematoma formation (14.8 % no pack, 7.3 % pack, p = 0.204) was not statistically significant. There were three clinically significant complications in the no pack group and none in the pack group.Conclusions This is the first study to examine pain in association with post-operative vaginal packing. There is no evidence to suggest that packing increases pain scores or post-operative morbidity. A trend towards increased haematoma and significant complications was seen in the no pack group. As vaginal packing does no harm and may be of some benefit it may be argued that packing should be recommended as routine clinical practice.
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Two trials with a total of 266 women evaluated POP surgery with or without vaginal packing.
“POP surgery with or without vaginal packing: two trials with a total of 266 women (Thiagamoorthy 2014; Westermann 2016).”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Thiagamoorthy 2014
In the same trial, there was no difference in postoperative pain scores (McGill Pain Questionnaire) between the vaginal pack and no vaginal pack groups.
“In the same trial, there was no difference in postoperative pain scores (McGill Pain Questionnaire) between the two arms.”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Thiagamoorthy 2014
In one trial, fewer pelvic haematomas on ultrasound at six weeks postoperatively were found in the vaginal pack group (7%) compared with the no vaginal pack group (15%).
“One trial did find fewer pelvic haematomas on ultrasound six weeks postoperatively in the vaginal pack group (7%) versus no vaginal pack group (15%) (Thiagamoorthy 2014).”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Thiagamoorthy 2014
In Thiagamoorthy 2014, the risk of selection bias from allocation concealment was low.
“Allocation concealment (selection bias) Low risk Opaque, sealed envelopes were used to conceal group allocation.”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Thiagamoorthy 2014
In Thiagamoorthy 2014, the risk of selection bias from random sequence generation was unclear.
“Random sequence generation (selection bias) Unclear risk No details were provided on the method used to generate the randomisation sequence.”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Thiagamoorthy 2014
In Thiagamoorthy 2014, the risk of performance bias from blinding of participants and personnel was high.
“Blinding of participants and personnel (performance bias) All outcomes High risk Study personnel and participants were blinded to group allocation until the primary outcome assessment was completed. However, it is possible that participants would have been aware of the presence of the vaginal pack.”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Thiagamoorthy 2014
In Thiagamoorthy 2014, the risk of detection bias from blinding of outcome assessment was low.
“Blinding of outcome assessment (detection bias) All outcomes Low risk All staff subsequently involved in assessing secondary outcome measures were also blinded to the group allocation. Both researchers and patients were informed of patients’ group assignment only after the pain questionnaire had been submitted to the ward sister.”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Thiagamoorthy 2014
In Thiagamoorthy 2014, the randomisation method was not stated.
“Randomisation method: not stated”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Thiagamoorthy 2014
In Thiagamoorthy 2014, intention-to-treat analysis was performed.
“ITT analysis: yes”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Thiagamoorthy 2014
In Thiagamoorthy 2014, the risk of attrition bias from incomplete outcome data was low.
“Incomplete outcome data (attrition bias) All outcomes Low risk Follow‐up rate 91.5%”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Thiagamoorthy 2014
In Thiagamoorthy 2014, trial registration details were not provided.
“Trial registration: no details”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Thiagamoorthy 2014
In Thiagamoorthy 2014, the risk of reporting bias from selective reporting was low.
“Selective reporting (reporting bias) Low risk All prespecified outcomes were reported.”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Thiagamoorthy 2014
In Thiagamoorthy 2014, a power calculation was performed.
“Power calculation: Sample size calculation: yes. Sample size of 86 in each group was calculated to provide 90% power to detect a clinically important difference in McGill Pain Questionnaire responses with an alpha error of 5%.”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Thiagamoorthy 2014
In Thiagamoorthy 2014, the risk of other bias was unclear.
“Other bias Unclear risk Patient‐requested additional analgesia; time to mobilisation and duration of inpatient stay were not reported.”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Thiagamoorthy 2014
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References 27 · Cited by 34
- Authors
- Thiagamoorthy, G., Khalil, A., Cardozo, L., Srikrishna, S., Leslie, G., & Robinson, D.
- Affiliations
- King's College Hospital (GB)
- St George's Hospital (GB)
- Corresponding author
- Thiagamoorthy, G.
- ORCID
- Robinson, D.
- Venue
- International Urogynecology Journal
- Published
- 2013-12-06
- Volume
- 25
- Issue
- 5
- Pages
- 585-591
- ISSN
- 0937-3462 (ISSN-L)
- 1433-3023
- OpenAlex
- W2101977256
- Cited by
- 34
- References
- 27
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 3 · 2023: 4 · 2022: 5 · 2020: 2 · 2019: 3 · 2018: 5 · 2017: 4 · 2016: 3 · 2015: 1
- FWCI
- 1.09
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- www.springer.com/tdm (tdm)
- Locations
- International Urogynecology Journal (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Rheumatology › Pelvic floor disorders treatments
- Health Sciences › Medicine › Obstetrics and Gynecology › Uterine Myomas and Treatments
- Health Sciences › Medicine › Obstetrics and Gynecology › Gynecological conditions and treatments
- Keywords
- vaginal packing, pelvic floor surgery, vaginal hysterectomy, pelvic floor reconstruction, postoperative pain, postoperative hematoma, postoperative infection, postoperative bleeding, urogynecology
- MeSH terms
- Adult, Aged, Aged, 80 and over, Double-Blind Method, Female, Humans, Hysterectomy, Vaginal, Middle Aged, Postoperative Pain, Postoperative Complications, Prospective Studies, Tampons, Surgical, Vagina, Pelvic Floor, Pelvic Organ Prolapse
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