Clinical trial NCT06902909: Laparoscopic Pectopexy and Laparoscopic Colporrhaphies in Pelvic Organ Prolapse Treatment
Official title: Laparoscopic Pectopexy and Laparoscopic Colporrhaphies in Pelvic Organ Prolapse Treatment
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Vaginal Vault Prolapse
Uterine Prolapse
Cystocele, Midline
Rectocele; Female
Keywords: laparoscopic pectopexy
laparoscopic colporraphy
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Seinajoki Central Hospital
First posted: 2025-03-30
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient-reported postoperative sensation of bulging at 12 months postoperatively
timeFrame: From the enrollment til follow-up visit at 12 months postoperatively
Secondary outcomes:
measure: Change in Pelvic Floor Organ function (PFDI-20 score)
timeFrame: From enrollment til the follow-up visit 12 months postoperatively
measure: Change in sexual function and urinary incontinence (PISQ-12 score).
timeFrame: From the enrollment til follow-up visit at 12 months postoperatively
measure: Change in quality of life. (15D questionnaire score)
timeFrame: From the enrollment til follow-up visit at 12 months postoperatively
measure: Change in pelvic pain (VAS score)
timeFrame: From the enrollment til follow-up visit at 12 months postoperatively
measure: Post voiding residual in ml.
timeFrame: From enrollment til the follow-up visit 12 months postoperatively
measure: Duration of surgery in minutes
timeFrame: From the beginning of surgery til the end of surgery
measure: Estimated blood loss in ml
timeFrame: From the beginning of surgery til the end of surgery.
measure: Surgical Complications according to Clavien-Dindo classification.
timeFrame: From the beginning of surgery til 30 days postoperatively
measure: Hospitalisation duration in days
timeFrame: From the hospitalisation for surgery til discharge home.
measure: Anatomical correction of prolapse according POP-Q classification
timeFrame: Right before the operaton til follow-up visit at 12 months postoperatively
measure: Global impression of improvement. (PGI-I questionnaire)
timeFrame: At follow-up visit 12 months postoperatively
measure: Re-operation rate due to recurrence of vaginal apical prolapse, cystocele or rectocele.
timeFrame: From the end of surgery til follow-up visit at 12 months postoperatively
Other outcomes:
Locations:
city: Seinäjoki
country: Finland
facility: The Wellbeing Services County of South Ostrobothnia
Study officials:
affiliation: Tampere University
name: Kirsi Kuismanen, MD, PhD
role: STUDY_CHAIR
affiliation: Tampere University
name: Kari Nieminen, MD, PhD
role: STUDY_CHAIR
References: