Evaluation of the Use of Synthetic Glue for Mesh Fixation in Laparoscopic Sacrocolpopexy

To determine whether or not the duration of fixation of the implant to the anterior and posterior vaginal walls using adhesive is statistically significantly shorter in minutes compared to standard fixation using sutures. The statistical evaluation will be based on time measured with a stopwatch (minutes). The time is measured from the start of fixation of the implant to the vaginal walls until it is completely anchored to the vaginal walls. This objective does not evaluate the time required for complete fixation of the implant including fixation to the promotorium, but only the time required to fix the implant to the vagina.

The total time (in minutes) required to manipulate the implant - from its insertion into the abdominal cavity to its fixation to the promontory (including fixation to the cervix and vaginal walls). The total time required for implant fixation between the two groups will be analyzed.

The total operative time (in minutes) is defined as the interval from the initial placement of all laparoscopic trocars to their subsequent removal. A statistical evaluation will be conducted to compare the total time required to complete the surgical procedure between the two groups.

All perioperative and all postoperative complications will be monitored. The severity of postoperative complications will be assessed according to the Clavien-Dindo classification.

All patients will receive analgesics during the postoperative period in accordance with the prevailing therapeutic protocol at the Gynecology and Obstetrics Clinic of the University Hospital Brno. The intensity of pain experienced by patients in the postoperative period will be documented using the Visual Analogue Scale (VAS 0-10) at 6, 24, and 48 hours following surgery. Furthermore, the necessity for opioid analgesics to manage pain will be documented. Subsequent analyses will compare the two groups with respect to the necessity of analgesic and opioid analgesic utilization in the early postoperative period.

In the late postoperative period (6 and 12 months), the recurrence of pelvic organ prolapse will be assessed in each compartment using a standardized Pelvic Organ Prolapse Quantification System (POP-Q). A finding of Ba ≥ -1, Bp ≥ -1, or C > TVL/2 is considered a recurrence. A statistical comparison will be conducted to evaluate the incidence of recurrence between the two groups.

Pelvic Floor Disability Index (PFDI-20) - This is a short form that provides a comprehensive assessment of the impact of pelvic floor disorders on women's quality of life. The PFDI-20 consists of 3 scales, including the Urinary Distress Inventory-6 (UDI-6), the Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6) and the Colorectal-Anal Distress Inventory-8 (CRADI-8). The PFDI-20 serves the role of both a symptom inventory and a measure of the degree of bother and distress caused by the broad array of pelvic floor symptoms. Lower scores indicate less distress caused by the presence of pelvic floor dysfunction symptoms. A comparative analysis of the groups will be performed in relation to the change in subjective perception of difficulties, as assessed by the PFDI-20, after surgery at predetermined intervals.

The Pelvic Floor Impact Questionnaire-7 (PFIQ-7) is a health-related quality-of-life questionnaire to assess life impact in women with pelvic floor disorders. The questionnaire incorporates scales from the Urinary Impact Questionnaire (UIQ-7), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ-7) and the Colorectal-Anal Impact Questionnaire-7 (CRAIQ-7). The emphasis of the questionnaire is directed towards the impact of pelvic discomfort on the day-to-day activities of the individual. The PFIQ-7 is a valuable tool for measuring changes in symptom severity over time, both before and after treatment, and as such is a useful addition to the existing array of health-related quality-of-life questionnaires. A comparative analysis of the groups will be performed in relation to the change in health-related quality of life, as assessed by the PFIQ-7, after surgery at predetermined intervals.

International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) - A questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in men and women. where higher scores indicate greater symptom severity. This tool determines the change from baseline - improvement or deterioration of urinary incontinence and will be used as a screening tool for de-novo urinary incontinence after surgery. Additionally, it includes a self-diagnostic item to help identify the type of incontinence. A comparative analysis of the groups will be performed in relation to urinary incontinence and de-novo urinary incontinence after surgery at predetermined intervals.

The PISQ-IR (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised) is a validated evaluation tool for the assessment of female sexual function in women with female pelvic floor disorders. The PISQ-IR is composed of multiple domains that address different aspects of sexual function. The single summary score will be used to evaluate change from baseline in both groups. Moreover, the individual domains of the questionnaire will be evaluated separately. A comparative analysis of the groups will be performed in relation to the change in sexual functions after surgery.

The Patient Global Imression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy. The PGI-I indicates overall satisfaction with post-operative condition based on this scale:

• Very much better; 2. Much better; 3. A little better; 4. No change; 5. A little worse; 6. Much worse; 7. Very much worse.

The PGI-I will be utilized to evaluate patient satisfaction with the postoperative status in comparison to the preoperative status. The patient will complete the PGI-I at predefined postoperative intervals 8-12 weeks, 6 and 12 months. Subsequently, a comparative analysis of the two groups will be performed on patient satisfaction with the postoperative condition.

The position of the implant will be measured using transperineal and transvaginal ultrasound. The position will be measured as a distance (in millimeters) of the lowermost visible mesh echogenicity from the bladder neck on the anterior vaginal wall and from the perineum on the posterior vaginal wall. A comparative analysis of the implant position in the two study groups will be conducted to ascertain whether the method of fixation exerts an influence on implant placement.

Any postoperative mesh complications associated with the implant will be recorded using a Prosthesis/Graft Complication Classification Code for both groups. The calculation will be made using the official IUGA/ICS classification tool available from: https://www.ics.org/complication

This part of the study aims to evaluate the total cost of care using adhesive fixation versus standard laparoscopic intracorporeal suturing. The cost of adhesive materials and applicators is significant compared to suture-only methods; however, if adhesive use reduces operative time considerably, financial savings may be achieved. The Controlling Department of University Hospital Brno will provide reports to assess total hospitalization costs, expressed in Czech crowns, which include material, operating room, and postoperative care expenses. These reports will be available three months post-discharge. The study seeks to compare hospitalization costs for adhesive fixation and conventional procedures.