A prospective, randomized controlled trial is set to investigate whether simultaneous perineoplasty enhances the effectiveness and safety of mesh-augmented sacrospinal fixation in women undergoing surgical repair for advanced pelvic organ prolapse (POP). The study, detailed in Trials Journal, aims to determine if concurrent perineal body reconstruction improves clinical and anatomical outcomes.
The rationale behind this trial stems from the opinion that comprehensive POP repair, addressing anterior, apical, and posterior compartments, should also include perineal body reconstruction to prevent future prolapse recurrence. However, current evidence supporting this approach is limited, prompting the need for rigorous evaluation.
Study Design and Methods
The trial will randomize patients into two groups:
- Mesh-augmented sacrospinal fixation with posterior colporrhaphy (hybrid pelvic floor reconstruction) and perineoplasty.
- Mesh-augmented sacrospinal fixation with posterior colporrhaphy (hybrid pelvic floor reconstruction) alone.
Both groups will undergo standardized surgical procedures, including anterior subfascial colporrhaphy and posterior subfascial colporrhaphy. The key difference lies in the second group's omission of perineal body reconstruction.
Surgical techniques involve the use of a mesh implant (Urosling 1, Lintex, St. Petersburg) for sacrospinal fixation, along with PGA sutures for colporrhaphy and perineoplasty (when performed). Endotracheal anesthesia will be administered, and postoperative care includes antibacterial prophylaxis, thromboembolic prevention, and pain management with nonsteroidal anti-inflammatory drugs or opioid analgesics.
Outcomes and Follow-up
The primary clinical endpoint is the objective cure rate, defined as the absence of POP recurrence requiring surgical treatment, assessed using the POP-Q classification (stage 0-1). Secondary endpoints include:
- Patient satisfaction, measured using the Global Impression of Improvement questionnaire (PGI-I).
- Sexual function, assessed with the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12).
- Quality of life, evaluated using the Pelvic Floor Disability Index (PFDI-20).
- Complication rates, including bleeding, hematoma, organ perforation, nerve damage, wound infection, and implant extrusion.
Patients will be followed up at 6, 12, and 24 months post-discharge for comprehensive assessment of outcomes.
Sample Size and Recruitment
The study aims to enroll 310 patients to detect a clinically significant difference in recurrence rates between the two groups. This sample size is based on an assumed recurrence rate of 7.4% for unilateral sacrospinous fixation and 1% for three-level reconstruction, with a power of 80% and a significance level of 5%. Participants will be recruited from SPBSU, with measures in place to minimize loss to follow-up.
Blinding and Randomization
While the surgical methods cannot be blinded from patients and medical personnel, the doctor responsible for data collection and patient examination at follow-up visits will be blinded to the patient's group assignment. Randomization will be performed using a computer-generated sequence with a 1:1 allocation ratio.
