Oct. 29, 2004 Results of a national clinical trial show a new saline-filled testicular implant is safe and improves quality of life. A UCSF team led the study, which involved patients at 18 sites.
"Our results suggest that a testis implant can provide an improved sense of well-being for patients who receive this prosthesis that is beyond simply cosmetic," said principal investigator Paul Turek, MD, associate professor of urology at UCSF. The findings are published in the current issue (October) of The Journal of Urology.
The saline-filled implant used in the trial was FDA-approved as an investigational device. This implant is used for patients with absent testis or testis loss with the goal of restoring normal appearance and quality of life.
Interest in a new type of implant developed in the mid-90s when a testicular prosthesis filled with silicone gel was discontinued by manufacturers in the U.S. due to concerns about the risk of connective tissue disease related to silicone breast implants, according to Turek. The silicone testicular implant had been used since its development in 1973.
The multi-site study of the saline-filled implant looked at the safety of the device, including signs and symptoms of connective tissue disorder. The study also is the first to formally and prospectively assess the quality of life benefit of a testis prosthesis.
The five-year study, 1998-2003, enrolled 149 patients who were followed for a minimum of one year. Men and boys missing one testis or both and without evidence of an active cancer or rheumatologic disease were eligible. The prosthesis consists of a silicone composite shell filled with injectable grade normal saline.
Among study participants, the adult group had been without a testicle for a median of two years and boys for a median of nine years. The mean age of adults was 31 years and of boys 13 years.
Study results showed that some participants suffered post operative discomfort after receiving the implant, but virtually all patient complications -- 98 percent -- were considered minor, according to Turek. Major complications included three implants that extruded and one that migrated, yielding an overall re-operation rate of two percent. All implants remained stable in size when assessed at three-month intervals.
Standard psychological questionnaires were used to assess self-esteem and perceptions of body image before and after testis prosthesis placement. Significant improvements in self-esteem and body image scores were seen in both adults and boys, particularly among boy participants.
"Using several validated scales, this study showed quantifiable increases in several areas of well-being, including improved self-satisfaction and self-esteem, physical attractiveness, and behaviors and feelings during sexual activity in appropriate age groups," Turek said.
"The study's outcome is particularly relevant for men with testicular cancer," he said. More than half of the study participants lost a testicle to orchiectomy, which is surgical removal to cure a patient of cancer. Sexual function may not be affected by orchiectomy but often, body image and self-esteem are, he emphasized. About 5000 men annually in the US lose a testicle due to cancer, making it and infection the main causes of testicular loss in men.
According to Turek, boys who might benefit from a prosthesis include those affected by cryptorchidism (undescended testes), damage due to torsion, or neonatal testis tumors. Trauma and orchitis, an inflammation of a testis sometimes associated with mumps, also account for a percentage of prepubertal loss.
Mentor Corporation provided the testis prosthesis and assisted with the study.
Study co-investigators were Viraj Master, MD, UCSF clinical instructor in urology, and members of the Testicular Prosthesis Study Group.
Study group members include: Martin K. Dineen, Daytona Beach, Fla.; Lawrence M. Goldstone and Hal Scherz, Atlanta; Edmond; Edmond Gonzales, Jr., Baylor College of Medicine, Houston; David; David A. Hatch, Loyola University Medical Center, Chicago; Gerald Jorda, Eastern Virginia Medical School, Norfolk, Va; Joel Kaufman, Aurora and Martin Koyle, Children's Hospital, Denver; Stanley Kogan, New York Medical College, White Plains; and Steven Tennenbaum, Columbia-Presbyterian Medical Center, New York, N.Y.
Also, Stephen Kramer, Mayo Clinic, Rochester, Minn.; David G. McLeod, Walter Reed Army Medical Center, Washington, D.C.; Michael O'Leary, Brigham and Women's Hospital and Alan Retik, Children's Hospital, Boston; Joseph Ortenberg, Children's Hospital, New Orleans; Juan Palomar, Wright State University School of Medicine, Dayton, Ohio; Mark Sigman, Brown University School of Medicine, Providence, R.I.; and George Steinhardt, St. Louis University.
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