Kelly-Keenedy Plication Versus Tension Free Vaginal Tape-Obturator (TVT-O) for the Treatment of Stress Urinary Incontinence: A Randomized Trial

Objective: To compare the objective and subjective cure rates of suburethral plication versus TVT-O in women with SUI. Methods: This is a randomized comparative trial done at a university hospital. Patients recruited were chosen to have urodynamic evidence of genuine SUI. They were randomized to have either suburethral plication or TVT-O. Patients were assessed preoperatively and postoperatively at 6 weeks, 6 months, and 12 months intervals. Objective cure rate was evaluated by the cough stress test. Subjective cure rates were evaluated by completing the short forms of an Arabic translation of the Urogenital Distress Inventory (UDI6) and the Incontinence Impact Questionnaire (IIQ7) preoperatively and postoperatively. The secondary outcomes that were evaluated were intraoperative and postoperative complications, voiding dysfunction, and urge symptoms. Results: One hundred ten patients were enrolled for surgery. 8 patients withdrew because of refusal or desire to delay surgery. 102 patients were randomized, 51 allocated for suburethral placation and 51 allocated for TVT-O procedure. Finally, 50 patients received suburethral plication and 49 patients received TVT-O procedure, 3 patients were excluded because of medical reasons. 91 patients completed 12 months follow-up; 43 in the suburethral plication group and 48 in the TVT-O group. There was no significant difference between the two groups regarding type of anesthesia, incidence of blood loss >250 ml, bladder perforation, vaginal perforation, UTI, wound infection, hematoma formation, PVR urine >100 ml, and de novo urge symptoms. Suburethral plication had significantly shorter operating time compared with TVT-O (28.4±2.3 Vs 29.9± 1.7, p<0.05). No cases in the sub urethral group suffered from groin pain compared with 5 cases in the TVT-O group (p<0.05). The objective cure rate defined as a negative cough stress test at 12 months follow-up was similar in both groups. There was no significant difference between the 2 groups regarding the preoperative UDI6 and IIQ7 scores. There was significant improvement in the two scores in both groups postoperatively. Conclusion: After 12 months follow-up, the suburethral plication and the TVT-O procedure are equally effective in terms of objective and subjective cure rates. There were no significant clinical complications regarding either procedure.