Methods
This was a single-centre double-blind parallel randomized controlled trial performed at a tertiary care teaching hospital (University Hospital, Faculty of Medicine in Pilsen, Charles University) in Pilsen, Czechia. The recruitment occurred in the study period November 2016 – June 2022. Approval was obtained from the Ethics committee of the Faculty of Medicine in Pilsen, Charles University (approval number 411/2016, approved October 6, 2016) prior to study commencement. The trial was registered in clinicaltrials.gov registry ( NCT02943525, registered October 21, 2016). All women with pelvic organ prolapse stage > 2 according to POPQ classification admitted for LSC without concomitant hysterectomy or with
supracervical hysterectomy were considered eligible for enrolment. Women undergoing any other surgery, concomitant vaginal surgery including suburethral sling or where vagina was opened during the surgery (e.g. during concurrent hysterectomy), were excluded from the study. Other exclusion criteria included clotting disorders, anticoagulant use as well as vaginal, uterine or ovarian malignancy. In addition, women with lost or incompletely filled-in pain questionnaire were excluded from this postoperative pain and satisfaction analysis. The primary outcome of the study was postoperative pain on day one after the surgery. The secondary outcomes were patient satisfaction with surgery on postoperative day 1 and satisfaction with the overall postoperative course, bacteriuria and anaemia on postoperative day 4.
The patients were enrolled either in consultation office or after admission to the hospital after signing the informed consent. Prior to the surgery the women underwent a complex urogynecologic examination including POP-Q staging, quality of life assessment and pelvic floor ultrasound. The surgical technique remained constant for the study period as described previously in detail 9, 10and was performed by four certified urogynaecologists proficient in the LSC surgical technique. Upon completion of the procedure, a surgical nurse opened an opaque sealed envelope to reveal each subject’s allocated study arm (1:1 randomization). This timing was chosen to reduce any bias or change in the surgical procedure as a result of the subject’s randomization 4. Patients in the intervention arm had a 100% cotton, fine mesh gauze, 7x150cm, soaked with 3% boric acid solution tightly packed into their vagina. The patients and the caring staff were both blinded regarding the allocated group until assessment of the primary outcome on day 1 after the surgery to avoid any bias. The postoperative pain was managed according to a standard clinical protocol equally regardless of allocated group. It was a standard to provide continuous morphine 0.5 – 2 mg per hour on the day of the surgery and then paracetamol 1g or metamizole 2.5g for breakthrough pain. The day after the surgery before potential extraction of the pack, the women were asked to complete the validated Czech version of the short form McGilll Pain Questionnaire 11. The short form of the McGill Pain Questionnaire provides five scores: sensory, affective, and total scores from the descriptors, and overall intensity scores from the Present Pain Intensity and Visual Analog Scale 12. Patient satisfaction was evaluated on a scale from 0 for “not satisfied” to 10 for “very satisfied” on the postoperative day 1 for overall satisfaction after surgery and on postoperative day 4 for overall satisfaction with the postoperative course. VAS was measured in mm and recorded in cm after rounding. Midstream urine sample was collected for culture and blood was taken for haemoglobin level assessment on postoperative day 4.
An independent statistician provided statistical analysis and advice throughout the study. The power calculation for the main outcome measure was adopted from a study by Thiagamoorthy et al., which calculated that 86 patients in each group were required to reject the null hypothesis of no difference between the groups with alpha 0.05 and 90 % power 5. The power calculation for patient satisfaction assessment using VAS was adopted from the study by Westerman et al.; 37 participants per group were needed to detect a mean difference of 14 mm on a 100-mm VAS with 90% power and an alpha of 0.05 4. More women were enrolled in the groups for assessment of surgical outcome and complications in one-year follow-up in the second part of this randomized controlled trial. All data were stored and collected using a clinical database and evaluated by the following statistical analyses depending on distribution of normality: Wilcoxon pair test, χ2 test, Kruskal-Wallis test, Fisher exact test, Median Two Sample test. P-value under 0.05 was considered statistically significant.