Fertility outcome of using intrauterine balloon stenting during resectoscopic septum division

To the Editor: With a great interest, I have read a recently published article in Annals of Saudi Medicine by Basim Fuad Abu Rafea et al, entitled “Fertility and pregnancy outcomes following resectoscopic septum division with and without intrauterine balloon stenting: a randomized pilot study”.¹ The authors skillfully declared an interesting investigation about the benefits of intrauterine balloon splinting/Foley catheter after resectoscopic septum division on fertility, septum reformation, and pregnancy outcomes. They concluded that “Following resectoscopic septum division with monopolar knife electrode, splinting the uterine cavity with Foley catheter provided no advantage in clinical pregnancy rate, septum reformation, and pregnancy outcomes.” Although this issue is a challenging topic in fertility and pregnancy, but there are some concerns in the mentioned study that undermine the reported findings to make a definite conclusion.

The number of cases included in the study is one of the most discussed queries. I can declare that if the difference between the 2 studied groups (balloon or no balloon) was not significant, it could due to the small amount of sample size that did not allow drawing any definitive conclusions. Thus, to rule out this query and to compensate any refusal of data, the authors should estimate the “power” of their study. The authors randomized the patients into the 2 studied groups, and no significant difference in terms of age, parity, and comorbidities were reported. However, menopausal status, race, age of menopause, menopausal hormone therapy, occupation, marital status, OCP use, and so on, should be distributed equally between the 2 groups before drawing any conclusion, which was not considered by the authors in this study.

The authors expertly excluded those patients who received preoperative endometrial thinning, adjunctive postoperative hormone therapy, or antibiotic prophylaxis, but they seemed to be inadequate as exclusion criteria in the clinical study. The authors did not declare if they excluded pregnant women, patients with active pelvic infection, patients allergic to radiographic contrast media, and patients with or without known endometrial or cervical cancer.^2,3 Therefore, the mentioned criteria should be considered by the authors. A participation fellow chart is mandatory for clinical studies based on the CONSORT (Consolidated Standards of Reporting Trials) statement,^4,5 but it was missing in this study. Moreover, in the ”Methods” section, the statistical analysis is poorly presented and the power analysis is incomplete. Moreover, the chosen proportion for significant or not significant difference in fertility and pregnancy outcomes should be mentioned. Finally, the secondary outcomes of the resectoscopic procedure, such as fever, increasing abdominal pain, heavy vaginal bleeding, foul smelling vaginal discharge,⁶ and so on, should be mentioned in the results by the authors.

We suggest that a study with accurate and powerful methods according to CONSORT statement is required for this topic. However, the authors acknowledged to the heterogeneity of their study population as a limitation. Therefore, future studies with a homogeneous sample, well-characterized controls, and cases that increase the sensitivity of detecting the associations should be considered necessary to exclude this problem.