The ethos of medicine is based on the importance of life and the indisputable equal value of all human beings. Working in sexual medicine, a field focused upon the most sensitive core of the human condition, ISSM has advocated from its beginning for the rights of all humans to be treated equally regardless of race, gender, religion, culture, ethnicity or sexual orientation.

ISSM, along with its 2,500+ multi-specialty members from 95 countries, is committed to encourage and support research in all these domains and continues to work towards our common goals in a united front with other medical and sexological societies.

ISSM believes that systemic discrimination based on any of the above should be condemned in the strongest terms. Furthermore, we support the concept of peaceful protest to combat systemic discrimination.

The ninth publication of the Journal of Sexual Medicine’s methodology update series will be Dr. Ryan Terlecki’s “A Quality Analysis of The Last Decade's Most Heavily Cited Data Relative to Outcomes After Penile Prosthesis Placement,” which was published in JSM’s May 2020 issue (https://doi.org/10.1016/j.jsxm.2020.02.025).

Ryan P. Terlecki, MD, is a urologist at Wake Forest Baptist Health in Winston-Salem, North Carolina, specializing in urologic reconstruction, infertility, and men’s and women’s sexual health.

To get a more in-depth understanding of the thoughts behind their paper, we conducted a text interview with the co-authors of the publication: Drs. Amy M. Pearlman, Ryan P. Terlecki, Jyoti D. Chouhan, and Robert C. Kovell:

1.  Can you comment on the role of surgeon volume and complication profiles? (Dr. Amy Pearlman)

“It seems logical to presume that a surgeon’s outcomes for a given procedure would improve with a greater volume of experience. Our literature review, however, did not find sufficient evidence to support this notion. There are other factors apart from surgeon case volume that are relevant to outcomes (e.g., patient characteristics, support staff experience, implant properties). Assessment of complication profiles is somewhat challenging. For instance, infection-related complications are not strictly defined and much of the published literature involving factors associated with revision surgery is based on voluntarily reported patient information forms obtained from industry.”

2. How should implant surgeons define patient satisfaction? (Dr. Ryan Terlecki)

“While surgeons must agree on ways to measure and report satisfaction, the patients are the ones to truly define this metric. Although some data suggests that restoration of sexual health may have implications for overall wellness, penile implant placement is still largely viewed as a quality-of-life procedure. If new validated instruments are to be developed and implemented, it would seem worthwhile to assess preoperative goals among patients and their partners, and to postoperatively determine to what extent these goals were realized. Surgeons may have a bias to avoid eliciting negative feedback, and simple reliance upon retrospective chart review is somewhat problematic if patients were not queried in a way to generate meaningful information for quality improvement. The absence of noted dissatisfaction is not equivalent to the presence of satisfaction.”

3. Could you comment on the fact that there is no consensus on using one specific, validated instrument to assess patient outcomes after implant surgery? (Dr. Jyoti Chouhan)

“There has been a steady increase in awareness regarding the importance and necessity of assessing patient reported outcome measures (PROMs) following surgery. As implanters are aware, patient satisfaction is paramount for these quality-of-life changing procedures. Consistent use of a PROM specific to penile implants among future studies would allow meaningful comparisons and potentially guide patient counseling and intraoperative decision-making. For many years, the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) and the International Index of Erectile Function (IIEF) were used to help standardize reporting. However, these are not implant specific. A European PROM, the Quality of Life and Sexuality with Penile Prosthesis (QoLSPP), has been created but not well reported in American literature. As a subspecialty, we should agree on a validated PROM that is used across all quality-of-life/satisfaction studies in this area.”

4. What did the literature search tell us about the real mechanical malfunction rate after implant surgery? How does the reporting system impact upon these figures? (Dr. R. Caleb Kovell)

“Modern penile implants are quite durable, with mechanical-failure free survival rates approaching 80% at 5 years, and still above 70% at 10 years.  When device revisions are necessary, about 65% of the time these will be due to mechanical failure.  Mechanical failure may involve issues such as fluid loss, failure of the pump or lock-out mechanism, or cylinder aneurysm.  Due to heterogeneity among these cases, reporting of mechanical failure is subject to some degree of misclassification bias.  Additionally, some patients who experience device malfunction may forego further evaluation, or decline offers of revision surgery, leading to potential under-reporting in studies based simply upon revision rates.  Ultimately however, our review of the literature suggests a high percentage of patients can expect the penile implant to perform reliably for many years.”

The tenth publication of the Journal of Sexual Medicine’s methodology update series will be Dr. Faysal Yafi’s “What is a ‘Validated Questionnaire’? A Critical Review of Erectile Function Assessment,” which was published in JSM’s May 2020 issue (https://doi.org/10.1016/j.jsxm.2020.02.005).

Faysal A. Yafi, MD, FRCSC, is the Medical Director of the Department of Urology Men’s Health Program at UC Irvine Health, specializing in andrology.

To get a more in-depth understanding of the thoughts behind his paper, we conducted a text interview with Dr. Yafi, along with one of his co-authors, Linda M. Huynh, MSc:

1. Can you give the reader a sense of the respective advantages and disadvantages of IIEF-6 (IIEF-EFD) and IIEF-5 (SHIM)? Which option should they use?

“First and foremost, the biggest misconception to address here is that the IIEF-6 is not simply the IIEF-5 with one additional question. Rather, the IIEF-6 consists primarily of the erectile function domain of the original IIEF and, therefore, most directly delineates “erectile dysfunction”. However, the IIEF-6 may lose some of its significance, as the last question on intercourse satisfaction is typically left blank.

"In contrast, the SHIM is validated not for 'erectile function' but rather as a metric for 'sexual function' and improvements therein. The context should be noted, as the original questionnaire was developed to measure patients’ response to pharmacotherapies and, therefore, functions more as a longitudinal comparator before and after any given patients starts ED medication.

"In short, the IIEF-6 is most often used cross-sectionally and as an assessment tool for ED at any given timepoint. In contrast, the SHIM facilitates assessment of longitudinal changes in sexual function – whether by use of pharmacotherapies or otherwise.”

2. What is the optional instrument or combination of instruments to be used in the radical pelvic surgery population when assessing baseline/postoperative sexual function?

“The most used instrument in assessment of baseline sexual function in radical pelvic surgery remains the SHIM, as it clearly delineates between those with no ED (i.e. and can expect some level of recovery) versus those with ED.

"Postoperatively, however, choice of assessment tool varies greatly. In the robotic radical prostatectomy community, for examples, erections sufficient for intercourse (ESI) is most used as it is a quick and easy way to assess post-operative recovery. However, when evaluating longitudinal recovery, the IIEF-5 is sensitive to change and allows for direct comparison between given timepoints. Lastly, the erection fullness scale generates a probability of 2-year sexual function recovery from 3-month scores.”

3. How do the authors integrate questionnaires into their clinical practice? Do they use paper or digitized versions?

“We utilize a combination of paper and digitized versions of the questionnaires, both of which are integrated longitudinally into our electronic health record and research databases. New technology via the REDCap (Research Electronic Data Capture) platform has facilitated this integration, with some surgeons in our practice obtaining passive response rates of >60% at all timepoints.”

4. Can you comment on the concept of linguistic validation and its importance in research?

“Linguistic validation is key in ensuring that the given questionnaire is conceptually equivalent across multiple languages and cultures. Any biases in phrasing or word choice, for example, may significantly alter the meaning of the questionnaire, its ability to be a relevant metric, and its predictive capabilities. In this regard, linguistic validation must be approached with the same rigor as is much of medical research.”