THE MULTICENTER TRANSCERVICAL BALLOON TUBOPLASTY STUDY - CONCLUSIONS AND COMPARISON TO ALTERNATIVE TECHNOLOGIES

Transvaginal tubal catheterization procedures have been suggested as an alternative to microsurgery and in-vitro fertilization (IVF) in the treatment of women with proximal tubal occlusion. A transcervical balloon tuboplasty (TBT) catheter was specifically developed and tested in a prospective multicentre trial. A total of 151 women with confirmed bilateral or unilateral tubal occlusion were studied. The primary study population included 106 women who, after exclusion of patients for protocol violations, represented those females who were treated for complete tubal occlusion with TBT. TBT is an ambulatory, minimally invasive catheter procedure, performed under paracervical block or mild sedation, which utilizes a co-axial balloon catheter under fluoroscopic guidance. Re-canalization, pregnancy and re-occlusion rates following the procedure were documented. A total of 28 patients demonstrating uni- or bilateral tubal patency after either hysterosalpingography and/or selective salpingography represented the control population. TBT established tubal patency of at least one Fallopian tube in 95/106 patients (90%) and in 167/205 obstructed oviducts (82%). Clinical pregnancies occurred in 37/106 females (35%), with a lite table adjusted rate of 37%. Patients without distal disease had significantly higher pregnancy rates than those with bipolar tubal disease (49% versus 12%, life table adjusted rate; P = 0.0002) but pregnancy rates were independent of underlying aetiology for tubal disease. Pregnancy rates in control patients who did not reach TBT because of tubal patency after hysterosalpingography and/or selective salpingography were significantly lower than in those successfully treated with TBT (P = 0.027), and occurred only for four cycles after hysterosalpingography and with approximately a 1 year delay after selective salpingography. On long-term follow-up 70% of TBT-treated females had either conceived or at least maintained unilateral tubal patency (life table adjusted rate). This study establishes procedures which utilize the vaginal/cervical approach, and especially the TBT, as primary procedures of choice in the treatment of selected patients with proximal tubal disease. It has potential medical as well as economic advantages over competing surgical procedures and over IVF.