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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anterior Colporrhaphy (AC) | No Intervention | Standard midline plication of pubocervical fascia using absorbable sutures under local anesthesia | |
| AC + Transobturator Lateral Suspension (TOLS) | Experimental | In addition to AC, bilateral non-absorbable sutures placed at the lateral edge of the pubocervical fascia, passed through obturator foramen, to provide lateral support |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOLS | Procedure | "Standard AC plus bilateral lateral suspension using non-absorbable sutures passed through the obturator foramen to support lateral vaginal wall." |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Recurrence Rate | Anatomical recurrence defined as POP-Q stage ≥ 2 in anterior compartment | 1 year postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Recurrence Rate | 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?" | 1 year postoperative |
| Patient Satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rok Sumak | University Medical Centre Maribor, Department of General Gynaecology and Urogynaecology, Maribor, Slovenia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre Maribor | Maribor | 2000 | Slovenia |
De-identified individual participant data (IPD) that underlie the results reported in this article, including baseline characteristics, intraoperative details, and outcome measures (objective recurrence, subjective recurrence, patient satisfaction, operative time, postoperative pain scores, and quality-of-life questionnaire scores), will be available to researchers upon reasonable request. Data will be shared beginning 6 months after publication of the main results and ending 5 years after article publication.
Start immediately, until 2027
Access will be granted to investigators who provide a methodologically sound proposal, subject to approval by the corresponding author and the Institutional Ethics Committee. Data will be shared via a secure institutional repository following signing of a data access agreement.
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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5-point Likert scale at 1 year |
| 1 year postoperative |
| Operative time | Measured in minutes during surgery. | 1 year postoperative |
| Postoperative Pain | Assessed via VAS at discharge and immediate postoperative period | 1 year postoperative. |
| Pelvic Sidewall Pain | Assessed at 1 year postoperative clinical examination, by pressing on obutrator membrane. Assesed as present or absent. | 1 year postoperative. |