EFFECTIVENESS OF A URINARY CONTROL INSERT IN THE MANAGEMENT OF STRESSURINARY-INCONTINENCE - EARLY RESULTS OF A MULTICENTER STUDY

Objectives. The purpose of this study was to test the safety and effec tiveness of a urethral insert for managing stress or mixed urinary inc ontinence. Methods. We performed a prospective, multicenter study of 1 35 female patients who were treated for 4 months with the Reliance Uri nary Control Insert. The effectiveness of the insert was measured obje ctively at the time of first use and after 4 months' use by standardiz ed pad weight studies. Insert effectiveness was also measured by repor ts of symptom improvement during patient interviews and on patient dia ries. Urine microscopy and culture were obtained monthly; cystoscopy a nd urodynamics were conducted at study entry and at 4 months. Results. Significant improvement in involuntary urine loss was observed. Objec tive measurement of urine loss revealed that 80% of the patients were completely dry, and 95% of the patients achieved greater than an 80% d ecrease in urine loss. In addition, patients' perceptions of acceptabi lity, incontinence symptom improvement, ease of learning, comfort, and time to habituation also showed improvements. Untoward events reporte d during the study included hematuria, bacteriuria, and bladder irrita tion. These events did not require significant medical intervention an d did not result in any long-term clinical sequelae. Conclusions. Thes e preliminary results indicate that the Reliance Urinary Control Inser t may be a safe, effective, and well-tolerated alternative to other av ailable methods for the management of stress or mixed incontinence in women. Additional long-term follow-up will be required to substantiate this conclusion.