Efficacy of Neuromodulation

[J Dimitrakov]

Journal of Pelvic Surgery 2002; 8(4):203-206

Percutaneous Peripheral Nerve Stimulation for Chronic Prostatitis/Chronic Pelvic Pain Syndrome

J. Curtis Nickel; Joe Downey; Dale Ardern; Alvaro Morales

Objectives:
Patients suffering from chronic nonbacterial prostatitis/chronic pelvic pain syndrome (CP/CPPS) that is refractory to standard therapy appear to have a chronic neuropathic condition in the pelvic/perineal area. Percutaneous peripheral nerve stimulation, which has been shown to modulate bladder function, may also improve the pelvic floor/pain symptoms associated with CP/CPPS. We undertook a prospective pilot study to examine the potential efficacy of the Stoller Afferent Nerve Stimulation (SANSTM) device in the treatment of CP/CPPS, employing validated prostatitis symptom scores as outcome measures.

Methods:
Patients with a diagnosis consistent with NIH chronic prostatitis / chronic pelvic pain syndrome Category III were treated with SANSTM with weekly 30-minute sessions for 6 weeks. If the patient or physician believed that amelioration of symptoms had occurred, the procedure was carried out for a further 6 weeks. Evaluation at baseline, 6 weeks (primary efficacy endpoint), and 16 weeks consisted of the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI), Symptom Severity Index (SSI), Symptom Frequency Questionnaire (SFQ), Quality of Life assessment (QoL) and Subjective Global Assessment (SGA).

Results:
Eleven patients (mean age, 42.9 ± 12.4 y; duration of symptoms, 6.4 ± 6.3 y) were enrolled. No patients experienced any significant adverse effects from therapy. There was no significant decrease in the total NIH-CPSI or the various subscores (pain, urinary, or quality of life) at 6 or 16 weeks compared to baseline. There was no significant decrease in severity or frequency of symptoms as measured by the SSI or SFQ. At 6 weeks, 3 patients (27%) experienced >25% improvement in total NIH-CPSI; 1 patient (9%) experienced >50% improvement in total NIH-CPSI. At 16 weeks 2 patients and 1 patient experienced a >25% and >50% decrease in symptoms, respectively. There was not a significant improvement in quality of life. At 6 weeks mild, moderate, and marked improvement were noted (SGA) by 3, 2, and 0 patients, respectively.

Conclusions:
SANSTM is well tolerated but does not appear to have significant efficacy in reducing severity and frequency of general symptoms, reducing specific pain symptoms, or improving quality of life in many male patients with CPPS. It appears that nerve stimulation must be given more frequently and/or for a longer duration than the program outlined in this protocol.

From the Department of Urology, Queen's University, Kingston, Ontario, Canada

Correspondence and reprint requests: Dr. J. Curtis Nickel, Department of Urology, Queen's University, Kingston General Hospital, Kingston, Ontario, Canada K7L 2V7.

The study was funded with an unrestricted research grant from Inter V Medical Inc (Canadian distributor for Urosurge). Dr. Nickel's Chronic Prostatitis Research Center is funded in part by an R01 grant from the National Institutes of Health (DK5374601).

Journal of Pelvic Surgery 2002; 8(4):203-206

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It would be interesting to see this protocol given with greater intensity.