doi:10.1016/j.ijrobp.2004.07.728 CLINICAL INVESTIGATION Cervix CLITORAL THERAPY DEVICE FOR TREATMENT OF SEXUAL DYSFUNCTION IN IRRADIATED CERVICAL CANCER PATIENTS MARYANN SCHRODER,PH.D.,* †‡§ LOREN K. MELL, M.D.,* † JEAN A. HURTEAU, M.D.,  YVONNE C. COLLINS, M.D.,  JACOB ROTMENSCH, M.D.,* ¶ STEVEN E. WAGGONER, M.D., ¶ S. DIANE YAMADA, M.D., ¶ WILLIAM SMALL,JR., M.D., # AND ARNO J. MUNDT, M.D.* † Departments of *Radiation and Cellular Oncology and ¶ Obstetrics and Gynecology, Section of Gynecologic Oncology, University of Chicago Pritzker School of Medicine, Chicago, IL; Departments of † Radiation Oncology, ‡ Public Health, Mental Health, and Administrative Nursing and  Obstetrics and Gynecology, Section of Gynecologic Oncology, University of Illinois at Chicago, Chicago, IL; # Division of Radiation Oncology and § Department of Psychiatry and Behavioral Sciences, Northwestern University School of Medicine, Chicago, IL Purpose: The purpose of this pilot study was to evaluate the efficacy of the clitoral therapy device (Eros Therapy) in alleviating sexual dysfunction in irradiated cervical cancer patients. Methods and Materials: Eligible patients had a history of cervical cancer treated with radiotherapy and self-reported sexual dysfunction of sexual arousal and/or orgasmic disorders. Patients used the noninvasive, nonpharmacologic clitoral therapy device using a hand-held, battery-powered vacuum to cause clitoral engorge- ment four times weekly for 3 months during foreplay and self-stimulation. Study instruments included the Female Sexual Function Index, Derogatis Interview for Sexual Functioning, and Dyadic Adjustment Scale. The outcome evaluation was performed at 3 months. Results: Between 2001 and 2002, 15 women were enrolled and 13 completed the study. The median patient age and radiotherapy– enrollment interval was 43.5 years and 2 years, respectively. At baseline, all patients reported symptoms of sexual arousal and/or orgasmic disorders, and some also had sexual desire and pain disorders. At 3 months, statistically significant improvements were seen in all domains tested, including sexual desire, arousal, lubrication, orgasm, sexual satisfaction, and reduced pain. The median Female Sexual Function Index total score increased from 17 to 29.4 (maximal score, 36; p <0.001). The median Derogatis Interview for Sexual Functioning total raw score increased from 46 to 95 (maximal score, 118; p <0.001). At baseline, the Derogatis Interview for Sexual Functioning total T-score corresponded to the bottom 10th percentile of normal sexual functioning. At 3 months, the total T-score placed the patients at the normalcy cutoff. Gynecologic examinations revealed improved mucosal color and moisture and vaginal elasticity and decreased bleeding and ulceration. Conclusion: Our results from this pilot study suggest that the clitoral therapy device may alleviate sexual dysfunction in irradiated cervical cancer patients. A randomized, controlled trial is warranted to assess the full benefits of this approach. © 2005 Elsevier Inc. Cervical cancer, Radiotherapy, Sexual dysfunction, Clitoral therapy device, Eros Therapy. Reprint requests to: MaryAnn Schroder, Ph.D., A.P.N., C.F.N.P., F.A.A.C.S., Department of Radiation and Cellular Oncology, Univer- sity of Chicago Pritzker School of Medicine, 5758 S. Maryland Ave., MC 9006, Chicago, IL 60637. Tel: (773) 702-2856; Fax: (773) 834-7340; E-mail: mschroder@radonc.uchicago.edu Presented in part at the American Society for Therapeutic Radiol- ogy and Oncology 44th Annual Meeting, October 6 –10, 2002, New Orleans, LA; the Society for Sex Therapy and Research, SSTAR 2003 28th Annual Meeting, March 6 –9, 2003, Miami Beach, FL; and the International Society for the Study of Women’s Sexual Health Annual Meeting, October 16 –19, 2003, Amsterdam, The Netherlands. Supported in part by a grant from UroMetrics, Inc., St. Paul, MN. The authors of this original paper and their immediate family members have no commercial, proprietary, or financial interests in the medical device (clitoral therapy device; Eros Therapy) or the company (UroMetrics, Inc.) described in this article. Research was conducted at the University of Chicago Depart- ment of Radiation and Cellular Oncology. J. Rotmensch, M.D. is currently at the Department of Obstetrics and Gynecology, Section of Gynecologic Oncology, Rush Univer- sity Medical Center, Chicago, IL. S. E. Waggoner, M.D. is cur- rently at the Department of Obstetrics and Gynecology, Section of Gynecologic Oncology, Case Western Reserve University, Cleve- land, OH. Acknowledgments—The authors thank Richard A. Carroll, Ph.D., Leonard Derogatis, Ph.D., S. Michael Plaut, Ph.D., and R. Taylor Segraves, M.D. for their helpful comments and criticisms of this manuscript. Received Mar 30, 2004, and in revised form Jul 19, 2004. Accepted for publication Jul 23, 2004. Int. J. Radiation Oncology Biol. Phys., Vol. 61, No. 4, pp. 1078 –1086, 2005 Copyright © 2005 Elsevier Inc. Printed in the USA. All rights reserved 0360-3016/05/$–see front matter 1078