A Randomized Controlled Trial of Patient-Controlled Valve Catheter and Indwelling Foley Catheter for Short-term Bladder Drainage.

OBJECTIVE

The purpose of this study was to compare catheter-related pain and quality-of-life scores between 2 catheters used after failed voiding trials following urogynecologic surgery.

METHODS

Women failing an inpatient voiding trial requiring short-term catheterization after urogynecologic surgery were randomized to receive either a standard FC or a patient-controlled VC. Subjects completed a 6-item, visual analog scale-based postoperative questionnaire (POQ) and an outpatient voiding trial 3 to 7 days after surgery. Baseline demographic, surgical data, and results of the outpatient voiding trial were recorded. The primary outcome was the difference in mean score for catheter-related pain on the POQ, based on intent to treat. Secondary outcomes included between-group differences in means for individual POQ items and a calculated composite satisfaction score. The statistician was blinded to group assignment.

RESULTS

Forty-nine subjects were randomized to FC (n = 24) and VC (n = 25). Two subjects, one in each group, were excluded from the primary analysis because of missing data. Mean age was 60.6 (SD, 12.5) years. Baseline characteristics were similar. Valve catheter users had a lower median catheter-related pain score (1.25 vs 2.3), but not significantly (P = 0.153). Valve catheter users had significantly lower median scores for frustration (1.2 vs 3.8; P = 0.018) and limitation on social activities (0 vs 7.6; P < 0.001). Mean composite satisfaction score was statistically significantly lower for the VC group (2.23 [SD, 1.83] vs 3.62 [SD, 1.95]; P < 0.01), suggesting greater satisfaction.

CONCLUSIONS

Valve catheter and FC users report similar catheter-related pain. Valve catheter users scored better in overall satisfaction, frustration, and limitations on social activities.