Over the next year, the Journal of Sexual Medicine will be publishing a series of special papers devoted entirely to the exploration of methodological challenges in the conduct of studies in the field of sexual medicine.

The purpose of these papers will be to inform and educate the journal’s readership on how to interpret the literature, as well as decipher studies and trials in a variety of areas in our field. The series will address studies across the breath of sexual medicine.

Paolo Capogrosso, MD, is a staff urologist at the University Vita-Salute San Raffaele in Milan, Italy. His methodology update, “Erectile Recovery After Radical Pelvic Surgery: Methodological Challenges and Recommendations for Data Reporting,” will kick off the series and was published in JSM’s January 2020 issue.

To get a more in-depth understanding of the thoughts behind the paper, we conducted a text interview with Dr. Capogrosso:

1. What do you consider to be the optimal regimen for penile rehabilitation after radical prostatectomy and why?

“There are currently no data showing that one penile rehabilitation protocol is better than the other in terms of erectile function recovery. In my practice I usually suggest patients to start oral PDE5is therapy with at least three sexual attempts per week. I would suggest intracavernous injections only as a second line therapy since most of the times patients show low compliance to this kind of treatment. Regarding emerging therapies for erectile dysfunction, thus including shockwaves and platelet reach plasma injections, I think there are insufficient data to be routinely suggested in the penile rehabilitation context.”

2. Do you believe there is a value in having non-nerve sparing radical prostatectomy patients pursue rehabilitation?

“Patients receiving a non-nerve sparing surgery should still receive treatments for erectile dysfunction after surgery for two main reasons: first, we will never be 100% sure regarding the magnitude of neurovascular bundle damage; some nerve fibers may have been spared during surgery. Second, If the patient was sexually active before surgery, he will ask for erectile dysfunction treatments after surgery. However, we should carefully counsel the patient regarding the low possibility of recovering even an acceptable drug-assisted erectile function.”

3. Is rehabilitation important in men after prostate radiation therapy? What about men using androgen deprivation therapies?

“Patients treated with radical prostatectomy will experience neuropraxia and erectile dysfunction in 100% of cases in the early period after surgery. For this reason, penile rehabilitation plays an important role in the post-surgical setting. Conversely, data from large randomized trials comparing different prostate cancer treatments, showed that radiotherapy is associated with a significantly lower risk of erectile dysfunction. After radiotherapy, patients may not experience erectile dysfunction and for this reason I believe they should be start penile rehabilitation only when a decrease in the erectile function is reported in the early period after treatment. The same concept should be applied also for patients treated with androgen deprivation therapy, although this specific subset of patients most of the times will suffer from advanced, metastatic prostate cancer and may not be motivated in sexual function due to high psychological distress.”

4. At what time after RP would you consider placing a penile implant in a patient with post-RP ED?

“There are data showing that about 50% of patients reporting erectile dysfunction at 1-year follow-up, may still recovery erectile function at 2 years. For this reason, I would encourage patients to stay on pharmacological treatment for at least two year before proceeding to surgery. However, patients with several comorbidities, older age and pre-operative erectile function may be submitted to penile prosthesis implantation at an earlier stage, since their chance of recovering erectile function is very low.”

5. Do you have a preference for the IIEF-6 or the SHIM (IIEF-5) in the post-RP population and why?

“In my practice I always use the IIEF-6 questionnaire since most of the studies on penile rehabilitation applied the IIEF-6 to investigate erectile function recovery. Moreover, the current definition of erectile function recovery is based on the IIEF-6 score (>=22 or 24 points). This allow us to have a reliable term of comparison when assessing patients’ erectile function in daily clinical practice.”

The second publication of the Journal of Sexual Medicine’s methodology update series will be Dr. Cindy Meston’s “Scoring and Interpretation of the FSFI: What Can Be Learned From 20 Years of Use?” The paper was published in JSM’s January 2020 issue.

Cindy M. Meston, PhD, is a Professor of clinical psychology and Director of The Sexual Psychophysiology Laboratory at The University of Texas at Austin, with a research focus on female sexuality.

To get a more in-depth understanding of the thoughts behind her paper, we conducted a text interview with Dr. Meston:

1. What is the importance of the FSFI?

“The FSFI is the most widely used, validated, and translated measure of sexual function in women. It is short (19 items), easy to administer, and has well established cut-off points for both overall sexual function and Hypoactive Sexual Dysfunction Disorder. As such, it serves as a reliable and efficient assessment tool for researchers and clinicians.”

2. What is most important to consider when using the FSFI?

“The FSFI does not examine distress which is a key diagnostic component included in both the DSM and ICD diagnostic systems.  As such, it does not take the place of a clinical interview and cannot be used alone to make clinical diagnoses. A validated scale assessing distress should be administered along with the FSFI for making clinical inferences.”

3. What are the most common pitfalls/mistakes when using the FSFI?

“As 15 of the FSFI items contain a zero option in the response set to indicate either “no sexual activity” or “did not attempt intercourse” within the past-four weeks, a requirement for using the FSFI to calculate a total sexual functioning score is that the participants have engaged in sexual activity and have attempted vaginal penetration over the past four weeks. There have been a number of studies published that have inappropriately administered the FSFI to women who are not sexually active and, in doing so, have reported invalid scores and potential misdiagnoses.”

4. What is missing in the FSFI?
“Sexual Desire is the only subscale that has a validated cut-off point. As such, the FSFI cannot be used to make clinical inferences for sexual arousal, orgasm, or pain disorders.”

5. How has it been to be involved in the development and use of the FSFI during the last 20 years?

“We, the original authors, had no idea the FSFI would become such a widely used instrument when we first gathered 20 years ago to discuss how best to conceptualize and assess women’s sexual function. I am so pleased to have been a part of the original scale development and to have had the honor of working with Ray Rosen on this project for so long. I’m pleased the scale has passed the test of time and hope that researchers will continue to validate the questionnaire for use among other populations of women.”