Laparoscopic Pectopexy and Laparoscopic Colporrhaphies in Pelvic Organ Prolapse Treatment

NCT06902909 | Enrolling By Invitation

• 1 other identifier: R23076
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Vault Prolapse; Uterine Prolapse; Cystocele, Midline; Rectocele; Female

Keywords

laparoscopic pectopexy; laparoscopic colporraphy

Outcome Measures

Primary Outcomes (1)

• Patient-reported postoperative sensation of bulging 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.

  From the enrollment til follow-up visit at 12 months postoperatively

Secondary Outcomes (12)

• Change in Pelvic Floor Organ function (PFDI-20 score)

  From enrollment til the follow-up visit 12 months postoperatively

• Change in sexual function and urinary incontinence (PISQ-12 score).

  From the enrollment til follow-up visit at 12 months postoperatively

• Change in quality of life. (15D questionnaire score)

  From the enrollment til follow-up visit at 12 months postoperatively

• Change in pelvic pain (VAS score)

  From the enrollment til follow-up visit at 12 months postoperatively

• Post voiding residual in ml.

  From enrollment til the follow-up visit 12 months postoperatively

Study Arms (1)

Laparoscopic pectopexy with or without concomitant laparoscopic colporraphy

Patients undergoing laparoscopic pectopexy for pelvic organ prolapse, with or without concomitant laparoscopic anterior and posterior vaginal wall repair using sutures. The procedure involves the placement of a 3x15 cm Dynamesh PRP PVDF mesh to the vaginal apex or uterine cervical stump with monofilament and multifilament sutures and anchored to the pectineal ligaments bilaterally. Follow-up assessments will be conducted 12 months postoperatively to evaluate symptom relief, anatomical correction, and surgical safety.

Eligibility Criteria

• Age: 18 Years - 79 Years
• Gender Eligibility Details: Laparoscopic pectopexy and colporrhaphies are gynecological surgeries and are therefore exclusively offered to patients who are female by birth.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic vaginal or uterine prolapse at least to the hymenal level and who have an indication for vaginal apex (DeLancey level I) prolapse repair using mesh are being recruited for the surgery.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampere University Hospital: lead
• Seinajoki Central Hospital: collaborator

Study Sites (1)

The Wellbeing Services County of South Ostrobothnia

Seinäjoki, 60200, Finland

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse; Uterine Prolapse; Cystocele; Rectocele

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hernia

Study Officials

• Kirsi Kuismanen, MD, PhD

  Tampere University

  STUDY CHAIR

• Kari Nieminen, MD, PhD

  Tampere University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 30, 2025
• Study Start: February 1, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)