Women's Apical Pelvic Organ Prolapse Treatment - a Randomized Controlled Trial Comparing Transvaginal and Laparoscopic Mesh Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 318
- Locations
- 1
- Primary Endpoint
- Subjective success; defined as the absence of vaginal bulge
Study Overview
Brief Summary
The main objective of the study is to compare subjective efficacy of trans vaginal mesh and laparoscopic colposakropexy (CSP) in women with an apical prolapse. The CSP group is further divided into two sub-groups; one where the mesh fixation is only at the apical part of the vagina, and another where the fixation is also extended to the levator plane.
The secondary outcomes are safety (peri- and post-surgery complications, pain, erosion), objective efficacy (simplified POP-Q), and re-operation rate. Subjective outcome also includes the assessment of sexual satisfaction. Cost-effectiveness is studied by comparing both direct costs and QALYs.
Detailed Description
Pelvic organ prolapse (POP) is defined as an anatomical support defect of the pelvic viscera. Women's POP is the descent of uterus or vaginal apex with or without concomitant descent of the anterior (cystocele) or posterior (rectocele) vaginal wall. It is estimated that the lifetime risk of POP surgery in women is approximately 10-13%, the incidence peak being 20-30 years after the first delivery, which is also the most important risk factor for POP. Other risk factors include previous hysterectomy, obesity and genetic factors.
The typical POP symptoms are a feeling of bulge, accompanied with urinary incontinence, defecation problems, and sexual dissatisfaction. First line treatments are conservative, but if they fail, surgery is indicated.
Native tissue repair of the anterior and / or posterior vaginal wall (colporrhaphy anterior / posterior) is commonly the first-line operation. The possible concomitant apical prolapse needs to be suspended which is typically done by either by performing a hysterectomy with shortening and suspension of the sacrouterine ligaments, or by amputation of the cervix with suspension of the cardinale and sacrouterine ligaments (Manchester operation). An unsuspended apical defect will double the relapse rate (20 vs 11%). In most of the apical recurrences mesh is used to achieve sufficient support. The re-operation rate of any POP in Finland is 10.8% .
In mesh operations the apex can be suspended either transvaginally (TVM) by anchoring the mesh to the sacrospinosus ligaments, or by doing a colposacropexy (CSP) where the mesh is attached to the sacrum, mostly via laparoscopy. The CSP techniques vary e.g. the mesh can be attached only apically or also to the levator plane. If needed, colporrhaphies can be done concomitantly.
The use of TVM has decreased due to the FDA-warnings and litigations concerning mainly the risks of erosion and pain. This has lead to withdrawals of mesh products, despite well-conducted clinical studies indicating that in well-chosen women light-weight small TVM is not associated with major complications. Currently, no TVM with good quality clinical data is available. Traditionally, CSP has been considered safer than TVM in regard of erosions and pain, but the data is scarce. Furthermore, CSP has a longer learning-curve and is a more time-consuming operation than TVM, whereas hospital stay is shorter.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age over 18 years and capability to understand the study protocol either in Finnish or Swedish.
- •Objectively diagnosed symptomatic apical prolapse (leading apical prolapse (points C/D) ≥ -2) and a history of previous POP operation including hysterectomy.
- •No need for any other concomitant operations except colporrhaphies and possible prophylactic salpingo-oophorectomy in CSP groups
Exclusion Criteria
- •A history of serious or prolonged pain after any operation or current or previous prolonged (over 6 months) pain of any reason.
- •BMI over 40
- •Regular use of systemic corticosteroid medication.
- •Incapability to understand the study protocol.
Outcomes
Primary Outcomes
Subjective success; defined as the absence of vaginal bulge
Time Frame: 5 years
Negative response to PDFI-20, question 3, at one-year following the surgery
Secondary Outcomes
- Peri and post-operative complications(1 year)
- Post-operative pain(1 year)
- Objective efficacy(1 year)
- Re-operation rate(1 year)
- Cost-effectiveness(1 year)
Investigators
Camilla Isaksson
Senior consultant
Helsinki University Central Hospital