Randomized study of the efficacy of enzyme therapy in women after surgical treatment for pelvic organ prolapse: A prospective randomized study

Background. The primary method of treatment for severe pelvic organ prolapse (POP) is surgery. Despite the significant number of surgical interventions, the high incidence of complications and relapses makes it necessary to search for new methods of surgical treatment. Also, the search for drugs that improve tissue healing in the wound continues in order to reduce the incidence of postoperative complications and the number of relapses.

Aim. To evaluate the effect of Phlogenzym® on the postoperative period in women undergoing surgical treatment of POP.

Materials and methods. An open-label, single-center, prospective, comparative, randomized study enrolled 124 patients who underwent surgery for POP and divided them into two groups. In the main group (n=64), patients received traditional (infusion, antibacterial) therapy in combination with Phlogenzym® 3 tablets 3 times a day for 30 days in the pre- and postoperative period, while in the comparison group (n=60), only traditional therapy was used. The study included the assessment of medical history, daily recording of the patient’s condition by such clinical parameters as pain assessment using the Visual Analog Scale, body temperature, wound condition (edema, flushing), duration of hemorrhagic discharge, and clinical and biochemical blood tests at admission and discharge from the hospital.

Results. The age of patients in the main group was 63.0 (56.8; 69.0) years versus 61.0 (54.3; 68.0) years in the comparison group; p=0.24. Patients of the main group showed more improvements for every single studied indicator of the complete blood count, except for the erythrocyte sedimentation rate. A relatively stable erythrocyte sedimentation rate was observed, indicating that enzyme therapy positively affected the wound. Patients in the study groups in the pre- and postoperative period did not differ significantly in most parameters of the blood chemistry tests. At the time of discharge, 60 (93.7%) patients in the main group and 49 (81.7%) patients in the comparison group had clinical improvement, which indicates a positive trend in wound healing (Pearson’s chi-square 3.19; p=0.08). There were no adverse events associated with the drug during the observation period.

Conclusion. Phlogenzym® in the standard of care for the pre- and postoperative period in the surgical treatment of POP is able to favorably influence on the mobile mechanisms of the repair of damaged tissue and stabilize the blood chemistry parameters, which presumably should be associated with the optimization of repair processes in the vagina. The results obtained and the absence of any side effects characterize Phlogenzym® as a drug with a favorable clinical profile for use in the pre- and postoperative period.