Anterior Vaginal Wall Prolapse, Pelvic Organ Prolapse
Conditions
Keywords
anterior colporrhaphy, transobturator lateral suspension, native tissue repair, randomized controlled trial, pelvic organ prolapse
Brief summary
Anterior colporrhaphy (AC) is commonly used for anterior vaginal wall prolapse, but suffers high recurrence rates. This randomized trial assessed whether adding transobturator lateral suspension (TOLS) to AC decreases objective recurrence without compromising patient outcomes. In a cohort of 44 women (POP-Q ≥ 2), AC alone was compared to AC+TOLS over a 1-year follow-up. Results showed significantly lower objective recurrence with the added suspension.
Detailed description
Conducted prospectively at University Medical Centre Maribor (Slovenia), this single-surgeon RCT randomized women with symptomatic anterior vaginal prolapse (POP-Q stage ≥ 2) to receive either standard AC or AC plus bilateral TOLS via non-absorbable suture across the obturator foramen. Primary outcome was objective anatomical recurrence (POP-Q ≥ 2) at 1 year. Secondary outcomes included subjective recurrence, satisfaction (Likert), operative time, postoperative and pelvic sidewall pain, and validated QOL instruments (UIQ-7, CRAIQ-7, POPIQ-7, PFIQ, POPDI-6, UDI-6, PFDI, PISQ).
Interventions
PROCEDURETOLS
Standard AC plus bilateral lateral suspension using non-absorbable sutures passed through the obturator foramen to support lateral vaginal wall.
Sponsors
University Medical Centre Maribor
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult women with symptomatic anterior vaginal wall prolapse (POP-Q stage ≥ 2) * Eligible for native tissue repair * Provided written informed consent
Exclusion criteria
* Previous anterior vaginal wall prolapse repair * Predominant apical or posterior compartment defect
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Recurrence Rate | 1 year postoperative | Anatomical recurrence defined as POP-Q stage ≥ 2 in anterior compartment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Recurrence Rate | 1 year postoperative | Subjective recurrence was determined by a positive response to the validated question: Do you usually have a bulge or something falling out that you can see or feel in your vaginal area? |
| Patient Satisfaction | 1 year postoperative | 5-point Likert scale at 1 year |
| Operative time | 1 year postoperative | Measured in minutes during surgery. |
| Postoperative Pain | 1 year postoperative. | Assessed via VAS at discharge and immediate postoperative period |
| Pelvic Sidewall Pain | 1 year postoperative. | Assessed at 1 year postoperative clinical examination, by pressing on obutrator membrane. Assesed as present or absent. |
Countries
Slovenia
Outcome results
None listed