Do bacteriostatic urethral lubricants affect the clinical efficacy of intravesical BCG therapy?

Purpose: We investigated the effect of a bacteriostatic urethral lubricant on the clinical efficacy of intravesical BCC therapy. Patients and Methods: Between July 1987 and August 1999, 389 patients with superficial urothelial carcinoma of the bladder (pTa (multilocular, size >2 cm, recurrent tumor), pT1, pTis) were treated adjuvantly with BCG in a 6-w eek intravesical cycle after complete transurethral tumor resection (TURB). Within the framework of a prospective study on recurrence and progression of superficial urothelial carcinoma of the bladder after TURB and BCG immun otherapy, we retrospectively studied the clinical value of the observation made by Bohle that the use of bacteriostatic urethral lubricants reduces th e viability and thus the efficacy of BCG. If we assume that the lubricant i nduces a clinically relevant reduction in the viability of BCG, then instil lation without lubricant should lead to a lower rate of recurrence and poss ibly a lower rate of progression. Whereas 11 ml lubricant was used during c atheterization in every male patient in our population (group I: n = 317, 8 1,5%), no lubricant was used in the women serving as the control group (gro up II: n=72, 18,5%). The two groups were similar with respect to age, distr ibution of tumor stage, grading, multifocality and frequency of previous bl adder carcinoma (Levene test, p=0,008). The median follow-up was 54 months (4-143). Results: 23,1% (n = 90) of the patients developed a recurrence during the f ollow-up period: 23% (n = 73) in group I and 23,6% (n = 17) in group II (n. s.). Progression occurred in 4.4% (n = 14) in group I and in 11% (n = 8) in group II (p=0,043). In group I 19,2% and in group II 47,1% of the recurren ces were progressive (p=0,026). Conclusions: The use of bacteriostatic lubricants in the usual dose prior t o BCG instillation had no detectable adverse effect on the clinical efficac y of intravesical BCC; immunotherapy. To avoid traumatic catheterization wi th possible systemic BCG administration we therefore recommend, especially in men, the additional use of a sufficient quantity of urethral lubricant.