Prospective randomized study evaluating ultrasound versus fluoroscopy guided sacral InterStim® lead placement: A pilot study

Abstract

Objective: To investigate the use of intraoperative ultrasound during stage I InterStim® sacral lead placement.

Methods: A total of 40 patients were randomly assigned to undergo InterStim® lead placement utilizing fluoroscopy or ultrasound guidance. Patients were blinded for the duration of the study. The surgeon and staff were blinded until after induction of anesthesia. Patients met criteria for refractory overactive bladder, fecal incontinence, or both. The ICIQ-OABqol, OABSS, and FIQL validated questionnaires were used pre- and post-operatively. Primary endpoint was total fluoroscopy time. Secondary endpoints were total radiation exposure and total number of foramen needle skin punctures.

Results: Forty patients were enrolled, twenty in the ultrasound and twenty in the fluoroscopy only arm. Mean age was 60 (SD = 14.4) and mean BMI 32 (SD = 7.2). Twenty-seven patients (67.5%) had urinary symptoms, four (10%) fecal incontinence, and nine (22.5%) had mixed symptoms. Radiation exposure time was reduced by 70.5 s (P = 0.002), radiation exposure was decreased by 42.3 mGy (P = 0.017), and the number of needle skin punctures decreased by 3.6 (P = 0.035) with use of ultrasound. Mean OR time in minutes was 55.5 in ultrasound and 58.2 in fluoroscopy group (P = 0.53). There were no statistically significant differences in questionnaire scores between groups.

Conclusion: Ultrasound guided placement of foramen needle during Stage I sacral neuromodulation results in reduction of radiation exposure to the patient, surgeon, and operating room staff. Further studies are necessary to determine the learning curve and efficacy of this technique.

Keywords: InterStim; fecal incontinence; overactive bladder; radiation; sacral neuromodulation; stage I; ultrasound.