Laparoscopic Pectopexy and Laparoscopic Colporrhaphies in Pelvic Organ Prolapse Treatment

• Conditions: Vaginal Vault Prolapse; Uterine Prolapse; Cystocele, Midline; Rectocele; Female

• Registration Number: NCT06902909
• Lead Sponsor: Tampere University Hospital

Brief Summary

This prospective cohort study investigates the surgical outcomes of laparoscopic pectopexy and laparoscopic colporraphy performed at the Wellbeing Services County of South Ostrobothnia. The primary outcome measure is to assess changes in sensation of bulge and pressure. Secondary outcome measures include evaluating other prolapse symptoms and pain, quality of life, anatomical correction of prolapse, surgical safety parameters, and postoperative complications. Approximately 40-50 laparoscopic pectopexies will be performed over two years by a single experienced surgeon. The study requires preoperative and postoperative assessments, including standardized patient questionnaires and anatomical measurements.

Detailed Description

The study aims to evaluate the effects of laparoscopic pectopexy and colporraphy on pelvic organ prolapse (POP) symptoms, anatomical prolapse repair, and surgical outcomes. The primary outcome measure is the presence of a bulging sensation 12 months after surgery. Secondary outcome measure includes additional prolapse-related symptoms, residual urine volume, pelvic pain, urinary incontinence, and safety parameters such as intraoperative blood loss and complications. Anatomical correction will be assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system.

All surgical procedures will be performed by a single experienced surgeon with over five years of experience and more than 100 laparoscopic pectopexies performed. Patients will undergo laparoscopic pectopexy, with or without concomitant anterior and posterior vaginal wall repair using sutures. The pectopexy procedure utilizes a 3x15 cm Dynamesh PRP PVDF mesh, secured with absorbable monofilament thread to the vaginal cuff or with non-absorbable multifilament sutures to the uterine cervical stump.

Study Timeline

• Study Start: 2024-02-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-03-24
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-30
• Last Update Posted: 2025-03-30
• Primary Completion: 2027-02-28
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Symptomatic pelvic organ prolapse
• Uterine or vaginal vault prolapse reaching the hymenal ring (POP-Q classification: ≥0 cm)
• If uterus in situ, consent for supracervical hysterectomy
• Suitable for laparoscopic mesh surgery
• Age: 18-79 years
• Non-pregnant, no pregnancy desire.
• Sufficient Finnish language skills
• Concurrent anterior and/or posterior prolapse repair if POP-Q criteria met: tvl >8 cm and Aa, Ba, Ap, Bp ≥0

Exclusion Criteria

• Unwillingness to undergo surgery or mesh implantation
• High anesthetic or surgical risk due to comorbidities
• Indication for laparoscopic sacrocolporectopexy due to rectal intussusception
• Desire to preserve the uterus
• Pregnancy or planning future pregnancy
• Inability to understand Finnish or study-related forms due to cognitive impairments
• Need for concomitant urinary incontinence surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient-reported postoperative sensation of bulging at 12 months postoperatively	From the enrollment til follow-up visit at 12 months postoperatively	During the history-taking process, symptoms such as a sensation of bulging or pressure are actively inquired about and documented accordingly. Results variables are presented as counts and percentages.

Secondary Outcome Measures

Name	Time	Method
Change in Pelvic Floor Organ function (PFDI-20 score)	From enrollment til the follow-up visit 12 months postoperatively	Patients are asked preoperatively and postoperatively to complete the Pelvic Floor Distress Inventory (PFDI-20) that contains 4 different scores: POPDI-6, CRADI-8, UDI-6 and PFDI-20 Sum score. For statistical analysis about measurement score changes, paired t-test will be used. The differences are considered to be statistically significant at p-value of \<0.05.
Change in sexual function and urinary incontinence (PISQ-12 score).	From the enrollment til follow-up visit at 12 months postoperatively	Patients are asked preoperatively and postoperatively to complete the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). For statistical analysis about measurement score change, paired t-test will be used. The differences are considered to be statistically significant at p-value of \<0.05.
Change in quality of life. (15D questionnaire score)	From the enrollment til follow-up visit at 12 months postoperatively	Patients are asked preoperatively and postoperatively to complete the Quality of Life 15D questionnaire. For statistical analysis about measurement score changes, paired t-test will be used. The differences are considered to be statistically significant at p-value of \<0.05.
Change in pelvic pain (VAS score)	From the enrollment til follow-up visit at 12 months postoperatively	Patients are asked to self-complete the Visual Analogue Scale (VAS) for pelvic pain both preoperatively and postoperatively. They are instructed to mark a cross or vertical line on a horizontal line labeled only with the endpoints: 0 (no pain) and 10 (worst possible pain), with no other numbers visible. A special ruler is used to determine the exact score based on the position of the mark, with results recorded to the nearest 0.5 points. For statistical analysis of changes in VAS scores, a paired t-test will be used. Differences will be considered statistically significant at a p-value of \<0.05.
Post voiding residual in ml.	From enrollment til the follow-up visit 12 months postoperatively	Postvoid residual (PVR) is measured by ultrasound during a transvaginal gynecological examination. Two dimensions are measured in centimeters in the sagittal plane, while the third dimension is consistently set at 10 cm. The PVR volume (in cubic centimeters) is calculated using the ellipsoid formula: a(cm)× b(cm) × c(10cm) × 0.52. One cubic centimeter is considered equivalent to one milliliter. For statistical analysis of changes in PVR measurements, a paired t-test will be used. Differences will be considered statistically significant at a p-value of \<0.05.
Duration of surgery in minutes	From the beginning of surgery til the end of surgery	During surgery, the following time measurements are recorded: total operative time (in minutes), defined as the duration from skin incision to completion of skin closure; and procedure-specific time (in minutes), which includes the time required for dissection of the pectopexy area, mesh application, and colporrhaphies. The results will be presented as the mean duration ± standard deviation (in minutes) and illustrated in a figure, with the X-axis representing individual cases and the Y-axis representing time in minutes for both types of measurements.
Estimated blood loss in ml	From the beginning of surgery til the end of surgery.	Estimated blood loss during surgery will be recorded in milliliters (ml). The results will be presented as the mean ± standard deviation in ml.
Surgical Complications according to Clavien-Dindo classification.	From the beginning of surgery til 30 days postoperatively	Surgical complications are recorded according to the Clavien-Dindo classification, from the beginning of surgery until 30 days postoperatively. Each adverse event is classified based on the Clavien-Dindo grading system. The results will be presented as counts and percentages of the study population in a table, where each complication is listed in a separate row and each grade of the Clavien-Dindo classification is represented in a separate column.
Hospitalisation duration in days	From the hospitalisation for surgery til discharge home.	The duration of hospitalization is recorded in days, calculated from the hospitalisation for surgery until the day of discharge. The results will be presented as the mean ± standard deviation (in days).
Anatomical correction of prolapse according POP-Q classification	Right before the operaton til follow-up visit at 12 months postoperatively	Anatomical correction is assessed during gynecological examination using the POP-Q system, both preoperatively and at the 12-month follow-up. The following points are measured: GH, PB, TVL, Aa, Ba, C, D, Ap, and Bp. For statistical analysis of changes in these measurements, a paired t-test will be used. Differences will be considered statistically significant at a p-value of \<0.05.
Global impression of improvement. (PGI-I questionnaire)	At follow-up visit 12 months postoperatively	Patient global impression of improvement (PGI-I) questionnaire is asked to fulfill by follow-up visit. It contains one question and seven answers. The results will be presented as counts and percentage for each possible answer.
Re-operation rate due to recurrence of vaginal apical prolapse, cystocele or rectocele.	From the end of surgery til follow-up visit at 12 months postoperatively	The re-operation rate due to recurrence of vaginal apical prolapse, cystocele, rectocele will be recorded. Results will be presented as the number and percentage of patients requiring re-operation during the follow-up period.

Trial Locations

Locations (1)

The Wellbeing Services County of South Ostrobothnia; 🇫🇮 Seinäjoki, Finland