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Low episodic rate of retrograde ejaculation found after ALIF with rhBMP-2
Investigators suggested endplate perforation may play a role in the incidence of the condition.
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In a study that was not sponsored by industry, researchers found a 1.4% overall episodic rate of retrograde ejaculation in men who underwent anterior lumbar interbody fusion with recombinant human bone morphogenetic protein-2.
“We felt that the use of recombinant [human] bone morphogenetic protein-2 [rhBMP-2] was safe with respect to retrograde ejaculation,” Alexander J. Ghanayem, MD, one of the study investigators at Loyola University, in Maywood, Ill., USA, said in a presentation at the North American Spine Society Annual Meeting.
Images: Ghanayem AJ
“Our episodic rate was two of 141 patients overall. If you look at levels that include L5-S1, it was 0.9%. If you looked at dose, we found no statistical difference whether we used 2.1 mg per single level vs. 4.2 mg,” he said.
Previous studies in question
Ghanayem noted that previous studies on retrograde ejaculation rates and rhBMP-2 use may have biased results due to corporate sponsorship. Therefore, he and John Santaniello, MD, conducted a retrospective review without corporate sponsorship of 148 men who underwent anterior lumbar interbody fusion (ALIF) surgery during a 7-year period.
The study authors performed the procedures with retroperitoneal exposure.
“You have to be careful of some of the rates that are quoted in the literature, the denominator [may include] men and women, which is not appropriate,” Ghanayem said.
Ghanayem and Santaniello excluded patients who did not have surgery at L4-5 or L5-S1 levels or who had surgery performed without the use of rhBMP-2.
Although four patients had preoperative erectile dysfunction, Ghanayem said fusion surgery did not affect their condition. According to the study abstract, two elderly patients, aged 67 years and 78 years, chose not to discuss ejaculatory/sexual function preoperatively and were excluded from the study. Another patient was excluded because surgeons abandoned using the retroperitoneal exposure during the operation.
Overall, two of the 141 remaining patients (1.4%) had postoperative retrograde ejaculation, one of which resolved, leaving a permanent rate of 0.7%.
Literature controls
Ghanayem highlighted a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study and a study conducted by Eugene J. Carragee, MD, on this subject. The FDA IDE study had corporate sponsorship and it found no link between rhBMP-2 cases and retrograde ejaculation. The study by Carragee, which did not receive corporate sponsorship, concluded that retrograde ejaculation was associated with rhBMP-2 use.
Ghanayem said in his presentation that his study showed retrograde ejaculation rates similar to those of the control groups in the FDA and Carragee studies, noting his study procedures did not perforate the endplates in the surgeries, which “may play a role in increased incidence of retrograde ejaculation.”
“We do not know what is the rate of episodic vs. permanent retrograde ejaculation,” Ghanayem said. “There are other primary causes that have not been explored.” – by Renee Blisard Buddle
- References:
- Carragee EJ. Spine J. 2012;doi: 10.1016/j.spine.4.2012.09.040.
- Ghanayem AJ. Paper #8. Presented at the North American Spine Society Annual Meeting; Oct. 24-27, 2012; Dallas.
- For more information:
- Alexander J. Ghanayem, MD, can be reached at Loyola University Medical Center-Mulcahy Outpatient Center, 2160 South 1st Ave., Maywood, IL 60153 USA; email: aghanay@lumc.edu.
Disclosures: Ghanayem is on the Board of Directors of Loyola University Physicians Foundation, is on the Grant Committee of OMeGA, is the chair of AOA Investment Committee and receives research support for staff or materials from DePuy Synthes Spine. Santaniello has no relevant financial disclosures. Both authors and their immediate families have not been consultants, served on speakers bureaus, received stock/options, or royalties from the manufacturer of rhBMP-2.
Perspective
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John C.Y. Leong, DSc(Hon), FRCS
Although impotence and retrograde ejaculation are possible serious complications in anterior lumber interbody fusions, impotence is almost unknown, and retrograde ejaculation has a very low incidence. Some patients with retrograde ejaculation recover with time.
In this study, no erectile dysfunction occurred in patients that did not have such a problem preoperatively. For retrograde ejaculation, there were two cases out of 141 patients, ie, 1.4%. Since one patient recovered, the final incidence was 0.7%.
These results are in line with experience at the Department of Orthopaedic Surgery, the University of Hong Kong. In an early review of 97 patients, there was one case of retrograde ejaculation which persisted, and in a further 213 patients there was a nil incidence of impotence and retrograde ejaculation. In a much larger series of 4,500 patients, compiled from different authors by Flynn and colleagues, the retrograde ejaculation rate was 0.42%
Their results have ruled out the possibility of recombinant human bone morphogenetic protein-2 being a causal factor in retrograde ejaculation.
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