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Setting the Course for More Options and More Choice in Prostate Cancer Care

The FDA has accepted a Biologics License Application (BLA) seeking approval of nivolumab (Opdivo) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20), or subcutaneous nivolumab, for the treatment of patients with all previously approved solid tumor indications for nivolumab as a monotherapy, monotherapy maintenance following completion of combination therapy with nivolumab plus ipilimumab (Yervoy), or in combination with chemotherapy or cabozantinib (Cabometyx).

Nivolumab is currently approved under several indications, including in combination with ipilimumab for the first-line treatment of patients with intermediate- or poor-risk advanced renal cell carcinoma (RCC), in combination with cabozantinib for the first-line treatment of patients with advanced RCC, for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy, and in combination with cisplatin and gemcitabine for the first-line treatment of patients with unresectable or metastatic urothelial carcinoma.

The FDA is set to have a decision regarding the subcutaneous nivolumab formulation on or by December 29, 2024.

 According to a news release from Bristol Myers Squibb,

 approval of the formulation would make it the first and only subcutaneously administered PD-1 inhibitor.

“We believe subcutaneous nivolumab has the potential to make a significant difference in the lives of patients, which is reinforced by the FDA’s acceptance of our application,” said Gina Fusaro, PhD, vice president, global program lead, Bristol Myers Squibb, in the news release.

 “Opdivo is a foundational PD-1 inhibitor approved for many different types of cancer, and our continued investment in research that puts patients first remains a priority. If approved by the FDA, the subcutaneous administration of nivolumab would provide patients and their physicians with a new option that delivers the same well-known benefits as IV Opdivo but with the improved convenience of an injection administered in 3 to 5 minutes rather than a 30-to-60-minute infusion.”

The BLA submission is supported by findings from the phase 3 CheckMate-67T trial (NCT04810078), in which subcutaneous nivolumab met the study’s co-primary end points by demonstrating noninferiority to intravenous (IV) nivolumab regarding time average nivolumab serum concentration over 28 days (C

; geometric mean ratio [GMR}, 2.098; 90% CI, 2.001-2.200) and minimum serum concentration at a steady state (C

Data from the study, which were presented at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, California,

 also showed that subcutaneous nivolumab demonstrated noninferiority to IV nivolumab in the key powered secondary end point of objective response rate (ORR). Specifically, the subcutaneous arm demonstrated an ORR of 24.2% (95% CI, 19.0-30.0) per blinded independent central review (BICR), compared with 18.2% (95% CI, 13.6-23.6) in the IV arm.

The safety profile for subcutaneous nivolumab was consistent with that of the IV formulation. Among patients who received the subcutaneous formulation, 8.1% experienced injection-site reactions, with all being low-grade and transient. Deaths due to study drug toxicity occurred in 3 patients in the subcutaneous arm and 1 patient in the IV arm. Most deaths that occurred during the study were due to disease progression.

In total, the phase 3, open-label CheckMate-67T trial enrolled 495 patients with advanced or metastatic ccRCC who had received prior systemic therapy. Patients were randomly assigned 1:1 to receive 1200 mg subcutaneous nivolumab plus rHuPH20 every 4 weeks (n = 248) or to 3 mg/kg IV nivolumab every 2 weeks (n = 247) for up to 2 years of treatment or until disease progression, unacceptable toxicity, withdrawal, or death.

The co-primary pharmacokinetic end points for noninferiority testing were C

 of subcutaneous nivolumab vs IV nivolumab. The key secondary end point was ORR per BICR.

Final completion of the CheckMate-67T study is expected in January 2026.

1. U.S. Food and Drug Administration accepts Bristol Myers Squibb’s application for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. Bristol Myers Squibb. May 6, 2024. Accessed May 7, 2024. https://news.bms.com/news/corporate-financial/2024/U.S.-Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-Application-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

2. Bristol Myers Squibb announces updated action date by the U.S. Food and Drug Administration for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. Published online and accessed May 21, 2024. https://investors.bms.com/iframes/press-releases/press-release-details/2024/Bristol-Myers-Squibb-Announces-Updated-Action-Date-by-the-U.S.-Food-and-Drug-Administration-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

3. George S, Bourlon TB, Chacon MR, et al. Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Pharmacokinetics (PK), efficacy, and safety results from CheckMate 67T. 

4. A study of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread (CheckMate-67T). ClinicalTrials.gov. Last updated March 1, 2024. Accessed May 7, 2024. https://clinicaltrials.gov/study/NCT04810078

The FDA is set to have a decision regarding the subcutaneous nivolumab formulation on or by December 29, 2024. 

News

FDA accepts BLA for subcutaneous nivolumab in solid tumors

This year has been a rollercoaster. Inflation finally came back within the Fed’s target range, but concerns about an underlying recession remain. Strong employment numbers have tempered those fears, but other indicators suggest we are not out of the woods yet. Existing and new geopolitical conflicts continue to foster global uneasiness. The US presidential election has been ramping up tensions and could spill over into the markets with high volatility. When your financial plan faces these types of challenges, the end of the year presents a good opportunity to regroup and close out 2024 in the strongest position possible and ready yourself for 2025. Below is a list of year-end questions everyone should ponder. The sooner these items are addressed and adjustments are made, the better position you will likely be in next year.

If you tapped into your emergency fund for any reason this year, it is important to make sure the account is replenished. It is always a good idea to review your budget and see whether your necessary spending has increased or decreased, and then review your emergency fund to ensure it is properly funded. As a reminder, the general rule of thumb for an emergency fund is to have 3 months of your necessary expenses saved in cash if you are a dual-income household and 6 months if you are a single-income household or one person earns significantly more than the other and their income is relied upon to maintain your family’s standard of living.

Have you maxed out your retirement accounts, or are they on track to max out by year-end? 

Contributions toward 401(k) and 403(b) plans must be made by December 31, 2024. The 2024 contribution limit for employee contributions is $23,000, or $30,500 if you are 50 years or older. Individual retirement account (IRA) contributions can be made up until the tax filing deadline in April 2025. The 2024 contribution limit for IRAs is $7000, or $8000 if you are 50 years or older.

Have you used all the money remaining in your Dependent Care or Health Care Flexible Spending Accounts (FSAs)? 

Withmost FSAs, you either use it or lose it, meaning any money left over in the account at the end of the year is forfeited back to the plan, not back to you. Some employers do offer a grace period into next spring or a $500 carryover from one year to the next for Health Care FSAs, but most do not. Make sure you use this money so you don’t leave anything on the table.

Have you made contributions to your children’s 529 accounts? 

As the cost of college continues to rise, it is important to start saving as soon as possible. Whether you’re trying to save for college or other post–high school opportunities, 529 plans offer excellent tax advantages. Many states offer a state income tax deduction for contributing to a 529 account. Sometimes, these tax savings can be substantial. Contributions must be made before December 31, 2024, to receive a 2024 tax deduction.

Have you designated all the gifts you planned to give this year? 

For 2024, the annual gift tax exclusion amount is $18,000 per person or $36,000 for a married couple. This means you can give cash or assets (such as investments) valued up to these amounts to an unlimited number of people without having to worry about gift taxes. Making gifts can be a great way to remove assets from an estate if future estate taxes are a concern. Gifts must be made before December 31, 2024.

Have you made your charitable donations for the year? 

Giving to charity can be a very powerful tool for tax savings. Check whether you have any appreciated investment assets you could donate instead of cash. Donating appreciated investments allows you to avoid paying capital gains taxes when you sell the investments, and you get to claim a deduction for the full value of the donated asset. The charity can then sell the investment and not have to pay capital gains taxes. However, be aware that with the increased standard deduction under current tax law, you may need to donate a substantial amount to see any tax benefit. Donations must be made by December 31, 2024, to count toward your 2024 taxes.

Have any of your investments lost money this year? 

Despite many indices having a solid year, there is always a possibility that 1 or more of your investments lost money during the year. If any investments in your taxable accounts are in the red, you could consider selling those investments to harvest the loss. Tax-loss harvesting can be used to offset gains elsewhere or potentially lower your 2024 tax bill. If your captured losses exceed your realized gains, you will have a net capital loss. Up to $3000 ($1500 if you are married and file separately) of net capital losses can be deducted against ordinary income, including salary, self-employment income, and interest income. Any excess loss above these amounts can be carried forward to future years to cancel out gains or deduct against income. Sales to capture losses must occur before year-end to count toward 2024.

Have you taken the required minimum distributions (RMDs)? 

RMDs are minimum amounts that IRA and retirement plan account owners generally must withdraw annually starting with the year they reach age 72 (or age 73 if you reach age 72 after December 31, 2022). You may also need to take an RMD if you inherited a retirement account. The penalty for not taking an RMD is 25% of the RMD amount; this was reduced in the Setting Every Community Up for Retirement Enhancement (SECURE) Act 2.0 from the previous penalty of 50%.

If there has been a major change in your life, such as a marriage or divorce, the birth or adoption of a child, or a death in the family, you may need to update the beneficiaries on your retirement accounts and life insurance policies. You may also need to update your will and power of attorney documents. There is no deadline for these changes, but the sooner the better.

There are likely to be other items to check on, but this list should give you a nice head start on making sure you close out the year on strong financial footing.

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"If you tapped into your emergency fund for any reason this year, it is important to make sure the account is replenished," writes Jeff Witz, CFP.

Money Matters: Go into 2025 strong with this year-end financial checklist

On November 1, 2024, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2025 Medicare Physician Fee Schedule Final Rule. It outlines CMS updates for payments and policies to take effect on January 1, 2025. A preview is available for download through the Federal Register Public Inspection website: tinyurl.com/4pa9zx6m.

 Without congressional action, the conversion factor (CF) is set to decrease to $32.35 for 2025 from $33.29 in 2024. This is a decrease of 2.83%. The decrease is due to several factors, mainly the expiration of a 1-time increase in the CF of 2.93% from action taken in March 2024 by the US Congress to mitigate the CF reduction that took place at the beginning of 2024. We hope lobbying efforts from organized medicine can mitigate this decrease in the face of inflationary pressures confronting all providers, including urologists. Even if this is successful, urology physician payments likely will fall short of keeping up with inflation.

Evaluation and Management (E/M) Services revisions, effective January 1, 2025. 

There are no significant changes for E/M codes for 2025 outside of the Medicare payment for the same services due to CF changes. Although not specifically an E/M code, the Healthcare Common Procedure Coding System (HCPCS) complexity add-on code (G2211) will be expanded to allow reporting this code with additional services such as annual wellness visits, vaccine administration, and preventive medicine visits. No other major changes for G2211 have been proposed. As always, we encourage urology practices to review education materials and protocols and to understand the appropriate use of G2211 for the remainder of 2024 and, based on this document, to prepare to continue using this code in 2025.

) manual introduced a new series of codes for telehealth services, creating codes for audiovisual and audio-only services for new and established patients. The code sets mirror the current Office or Other Outpatient E/M codes by having 4 levels each. Despite these codes being published by 

 codes 98001 through 98015) have been assigned a status of I by CMS and will not be reimbursed by Medicare (I: Not valid for Medicare purposes. Medicare uses another code for reporting of, and payment for, these services. This code is not subject to a 90-day grace period.) One code (

 98016) was accepted by Medicare for payment and assigned an active status indicator. 98016 describes “Brief communication technology-based service (eg, virtual check-in) by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related evaluation and management service provided within the previous 7 days nor leading to an evaluation and management service or procedure within the next 24 hours or soonest available appointment, 5 to 10 minutes of medical discussion.” This code will replace HCPCScode G2012 on January 1, 2025. With the addition of the 8 new 

 codes for audio-only service (4 levels of new and 4 levels of established patient codes), 

 codes 99441 through 99443 were deleted and will no longer be reportable.

 Medicare projects that RVU changes for urology will result in a 0.0% decrease in overall RVU production on a similar volume of services for 2025. The 

 includes changes for the total RVU by more than 5% (increase or decrease) from 2024. Although the work RVU for procedure did not change, the reduction in total RVU was driven by the practice expense RVU changes. In the proposed rule, Medicare advised changing the reimbursement of certain practice expense supplies for those they felt were potentially misvalued, especially in those packs where the reimbursement for the pack exceeded the cost of the individual supplies. In urology, this affected the supply packs for cystoscopic procedures. Although supply pack for endoscope disinfection (SA042), described as“pack, cleaning and disinfecting, endoscope,” increased from $19.43 to $31.29, the pricing of the “pack, drapes, cystoscopy” (SA045) decreased from $17.33 to $14.99 and the “pack, urology cystoscopy visit” (SA058) was initially reduced from $113.70 to $37.63. Through comments and the efforts of urology associations and individuals, in the final rule Medicare agreed to phase in the changes of supply pack SA058 over 4 years, finalizing a plan to reduce the reimbursement for this pack to $94.68 for 2025, $75.67 for 2026, $56.65 for 2027, and $37.63 starting in 2028.

 published 17 new telehealth codes. Medicare will not reimburse for 16 of those codes and has advised that practices continue to report the current Office and Other Outpatient E/M services for telehealth services.

Medicare continues to maintain the services listed on the covered telehealth services from categories to permanent or provisional. Of note, CMS has decided to keep code 77427 on the provisional telehealth list for 2025, a change from the proposed rule. Most of the remaining proposed additions or rejected additions were unchanged from that of the proposed rule.

 The maintenance of the list indicates that CMS remains highly supportive of telehealth and will continue to develop rules to support payment of telehealth services as allowed by law.

CMS is extending “incident-to” supervision through remote audio-visual “immediate availability” through December 31, 2025, for all services considered clinically appropriate to ease the transition from the public health emergency exemptions and to collect additional data. It has indicated it will permanently allow audiovisual “immediate availability” for certain low-risk services for codes such as 99211 and Professional Component/Technical Component codes with an indicator of 5. CMS proposes to analyze data with concern for patient safety and add codes to this permanent list through future rulemaking.

The current laws covering telehealth services expire at the end of 2024. It will take an act of Congress in an election year to make coverage of telehealth and telephone services permanent for Medicare. The final rule states that telehealth coverage will revert to prepandemic rules on January 1, 2025. We remain hopeful that Congress will kick the can down the road another year. Organized medicine, including the American Urological Association (AUA), continues to lobby for permanently adopting Medicare coverage of telehealth. We encourage all to support your AUA, Large Urology Group Practice Association, American Association of Clinical Urologists, and American Medical Association political action funds and lobby your representatives and senators to support permanent telehealth coverage by Medicare, regardless of political affiliation. We also encourage you to motivate your patients to join the push to make this valuable service permanent.

In this final rule, CMS has also stated that audio-only visits will be considered equivalent to audio-visual visits if the physician/group can offer audio-visual visits to the patient and the patient cannot perform the visual portion due to technical limitations or personal preference. With the deletion of 

 codes 99441 to 99443, CMS has indicated that if a visit is covered and meets the conditions listed above, the audio-only visit would be reported using the E/M code reflective of the service, with modifier -93 appended to indicate audio-only service.

Note: In 2025, Medicare will allow and cover mental health, substance use disorder, and a few limited specially designated services. If Congress allows telehealth to continue under the current rules, the change for reporting telephone-only services will be supported under this final rule, and billing for audio-only visits will be changed to E/M codes under medical decision-making or time with modifier -93.

Modifier -54 is used to append a 90-day global procedure 

 code when the practitioner provides only the surgical care (along with immediate preoperative and postoperative care) but does not provide the remainder of the outpatient postoperative care within the global period. Modifiers -55 and -56 are appended to the same surgical 

 code by a practitioner providing outpatient postoperative global and preoperative care, respectively. These modifiers are used in instances when there is a formal transfer-of-care agreement. Medicare states that it, per data gathered by RAND, conservatively estimates that modifier -54 should be used about 20% of the time for select codes and that these codes are likely underutilized. Medicare aimed to broaden the applicability of transfer-of-care modifier -54 for 90-day global packages to ensure compliance with these rules.

For 2025, Medicare is enforcing modifier -54 for the surgeon who knowingly provides only surgical, preoperative, and immediate (eg, in-hospital) postoperative care. If the operating physician intends the patient to return for follow-up care (eg, no formal agreement), the operating physician may report the service provided without the modifier. If there is a formal agreement, the appropriate practitioners should utilize modifiers -54, -55, and -56. For example, suppose a practitioner knowingly provides follow-up care for a patient. In that case, modifier -55 should be appended to the same 

 code by that provider as the surgeon, who would append their code with modifier -54.

Medicare recognizes that coordinating services or the choice of a patient to not follow the advice of the operating physician are difficult to control and therefore the implementation of a transfer of care based on the care provided is not always in the best interest of the patient. This change will allow Medicare to review the records of the operating physician in cases of separate follow-up care by a different physician of the same specialty to analyze split global payments further. It will be important for physicians providing procedures to indicate instructions for follow-up care clearly; in our review of records, this should not require a significant change in documentation for most urologists.

However, Medicare acknowledges extra work and resources are incurred by a practitioner who did not perform the procedure and is performing postoperative care. Medicare, therefore, finalized a new HCPCS add-on code, G0559, for use when follow-up care is provided by a physician other than the practitioner (or a practitioner within the same group practice) who performed the procedure. This code will be valued at 0.16 work RVU and will be defined as follows:

Postoperative follow-up visit complexity inherent to evaluation and management services addressing surgical procedure(s), provided by a physician or qualified health care professional who is not the practitioner who performed the procedure (or in the same group practice) and is of the same or of a different specialty than the practitioner who performed the procedure, within the 90-day global period of the procedure(s), once per 90-day global period, when there has not been a formal transfer of care and requires the following required elements, when possible and applicable:

++ Reading available surgical note to understand the relative success of the procedure, the anatomy that was affected, and potential complications that could have arisen due to the unique circumstances of the patient’s operation.

++ Research the procedure to determine expected postoperative course and potential complications (during a postoperative visit for a procedure outside the specialty).

++ Evaluate and physically examine the patient to determine whether the postoperative course is progressing appropriately.

++ Communicate with the practitioner who performed the procedure if any questions or concerns arise (list separately in addition to office/outpatient evaluation and management visit, new or established).

HCPCS code G0559 would be reported by a physician or other practitioner who did not perform the surgical procedure for a global package and provides related postoperative visits during the global period despite the absence of a formal transfer of care. This code would only be reported with an office or other outpatient E/M during the postoperative global period of 90 days. This code is intended to help offset the additional time, resources, and complexity involved in the first E/M visit following a procedure and may be billed in certain instances when a transfer-of-care modifier was not appended to the claim. Documentation in the medical record should indicate the relevant surgical procedure to the extent the billing practitioner can readily identify it. This code could be billed only once during the 90-day global period for the global package. This code is assigned a ZZZ global period and is reportable with an E/M visit. This code can be reported with a formal transfer of care or when no formal transfer agreement exists. It may be billed by a practitioner of the same specialty as the proceduralist who is not in the same group practice but should not billed by another practitioner in the same group practice as the practitioner who performed the surgical procedure.

Regarding changes to the Merit-based Incentive Payment System, we refer you to our earlier column on the proposed rule: 

The final rule for 2025 poses several challenges to urology. Lobbying efforts to preserve telehealth access and the CF will continue, perhaps dragging into 2025. Practices will have to adjust budgets and once again absorb cost increases while facing cuts to some high-volume procedures. The 0.0% projected RVU impact for urology reflects slight increases in practice expense (PE) values for clinical staff for most procedures to offset the decreases in PE values for the high-volume procedures listed above. The conversion factor, if preserved by Congress, will not offset cost increases for staff and other expenses. As every dollar counts, the battle to preserve the CF to avoid a decrease will need support.

For telehealth, the uncertainty the final rule creates should cause practices to consider how to schedule patients at the beginning of the year. Practices may wish to consider adjusting schedules for traditional Medicare patients regarding telehealth visits. It is recommended that the year be started by informing patients that telehealth will not be available or may be rescheduled due to Medicare rules and encouraging them to call their senator or representative.

The information in this column is designed to be authoritative, and every effort has been made to ensure its accuracy at the time it was written. However, readers are encouraged to check with their individual carrier or private payers for updates and to confirm that this information conforms to their specific rules.

"The final rule for 2025 poses several challenges to urology. Lobbying efforts to preserve telehealth access and the CF will continue, perhaps dragging into 2025," write Jonathan Rubenstein, MD, and Mark Painter.

Final rule: Conversion factor set for 2.83% reduction in 2025

Findings from a recent analysis presented at the 

2024 Annual Fall Scientific Meeting of the Sexual Medicine Society of North America

 (SMSNA) in Scottsdale, Arizona suggest that patients with symptomatic hypogonadism (“low T”) are turning to TikTok, a popular video-based social media platform, for information related to testosterone replacement therapy (TRT).

However, the analysis showed that many of these videos fail to discuss the negative long-term impact of these treatments.

The authors explained, “Patients are increasingly turning towards non-medical institutions for low T information and supplementation. By the time patients seek medical care, it may be due to improperly advised negative side effects.”

For the study, the investigators wrote a custom program to interface with the TikTok’s research application program interface (API). They searched for the most viewed TRT-related content via associated hashtags such as #trt, #lowt, and #testosterone. Videos were eligible for inclusion if they were in English, had text/verbal content, and were related to the subject matter.

The video content was then assessed by 2 independent reviewers, who graded the videos based on the American Urological Association’s (AUA) Testosterone Deficiency Guidelines (TDG) 

Between October 2022 to October 2023, the investigators identified 562 videos. Of those, 50 videos created by 22 unique accounts met the criteria for inclusion in the study. Combined, these videos had more than 15 million views, nearly 1 million likes, and 35,000 shares.

A majority of included videos (72%; n = 36) were created by companies to advertise their proprietary supplements. The most common ingredients in these supplements were shilajit, tongkat ali, and ashwagandha root.

Only 1 of the 22 unique creators was a physician, who was trained in family medicine and was advertising his low testosterone screening service based on his personal experience with hypogonadism.

Among all videos, 36% mentioned that TRT may improve erectile function, lean body mass, and/or depressive symptoms, which is referenced in AUA-TDG14. However, only 4 videos flagged that there is inconclusive evidence on the ability of TRT to improve cognitive function, mentioned in AUA-TDG15, or encouraged lifestyle modification as a treatment strategy prior to TRT, referenced in AUA-TDG21.

Further, none of the videos mentioned the long-term impact of exogenous testosterone on spermatogenesis for those interested in future fertility, which is highlighted in AUA-TDG16.

Based on these findings, the authors indicated a need for more accurate and non-commercialized content created by physicians.

They concluded, “Patients turn to non-medical resources for low T information and supplementation, but these videos rarely discuss negative side effects. Given the lack of educational, non-commercial videos about TRT benefits and risks on popular content platforms like TikTok, we urge physicians to actively engage in creating accurate and holistic content to reach patients currently consuming health care disinformation.”

1. Cheng LG, Huang SL, Hwang K. TikTok for low T: Testosterone replacement therapy misinformation and supplementation on a popular video platform. Presented at: 2024 Sexual Medicine Society of North America Fall Scientific Meeting. October 17-20, 2024. Scottsdale, Arizona. Poster 209

Patients with symptomatic hypogonadism are increasingly using TikTok for information on testosterone replacement therapy (TRT), but many videos lack discussion of long-term negative impacts. A study analyzed 562 videos, finding that most were created by companies promoting supplements, with only one physician among the creators. While some videos mentioned potential benefits of TRT, few addressed inconclusive evidence or lifestyle modifications. None discussed long-term effects on fertility. The study highlights the need for accurate, non-commercial content from physicians to counter misinformation on platforms like TikTok.

None of the videos mentioned the long-term impact of exogenous testosterone on spermatogenesis.

TikTok content on low testosterone lacks information on future risks, study finds

A study presented at the 2024 Sexual Medicine Society of North America Fall Scientific Meeting in Scottsdale, Arizona sheds light on patient satisfaction by location of the 3-piece AMS 700 with MS pump inflatable penile prosthesis (IPP).

Investigators led by Mohit Khera, MD, MBA, MPH, professor of urology at Baylor College of Medicine in Houston, used data from the It MATTERS (NCT04200937) prospective, multi-center registry to evaluate patient demographics and patient satisfaction responses in men whose AMS 700 reservoir was placed in prevesical space or ectopic space. Patients who were 18 years of age or older and had chronic, organic ED were included in the study. Follow-up took place post surgery and at 6 months, 12 months, and annually thereafter.

The investigators reported that 78 AMS 700 devices have been implanted, with reservoirs in the prevesical (n = 58) or ectopic (n = 20) space in 10 sites in the US.

“There were no significant differences in patient age, height, weight, or [body mass index] between groups, suggesting the patient’s physical composition may not be a significant factor in choosing the reservoir location. The general medical history of patients in both groups was similar, though patients with reservoirs placed ectopically had significantly more ‘other’ diagnoses falling outside of those previously listed, wrote the authors.

Mean duration of erectile dysfunction was 8.8 years, and the difference in mean duration of erectile dysfunction between the 2 groups was not significant (

= .638). Prostatectomy was the most common etiology of erectile dysfunction in the ectopic space (75%) vs 10.3% in patients whose reservoir was place in the prevesical space.

The investigators conducted post-surgery follow-up surveys between 0 and 90 days after surgery. A total of 67 responses were received, 50 of which came from the prevesical space group and 17 of which came from the ectopic space group. A majority of patients in both groups reported that they were either satisfied or very satisfied with the location of the reservoir. In terms of physical level of comfort, 52.0% (26/50 patients) in the prevesical space group said they were either comfortable or very comfortable, and 64.7% (11/17 patients) in the ectopic space group said they were either comfortable or very comfortable.

“Both groups of patients were asked whether they believed they felt the reservoir in the time since surgery, and a greater number of patients with a reservoir in the prevesical space responded ‘yes’ than those with a reservoir in an ectopic location (46.0% [23/50] vs 23.5% [4/17], respectively), though this difference was not significant (

“The take-home message…is it doesn't matter whether you put the reservoir in the ectopic location or the prevesical location. Patients tend to be satisfied in both locations,” Khera told 

The authors also stated in their conclusion that “Further enrollment and larger subgroups will allow for a more detailed understanding of differences in these groups over time.”

1. Khera M, Carrion R, Tadros N, et al. Comparing preliminary demographics and patient satisfaction by location of 3-piece IPP Reservoir: It Matters. Presented at: 2024 Sexual Medicine Society of North America Fall Scientific Meeting. October 17-20, 2024. Scottsdale, Arizona. Abstract 321

A study evaluated patient satisfaction with the AMS 700 inflatable penile prosthesis (IPP) based on reservoir location, either prevesical or ectopic. Conducted by Mohit Khera and colleagues, the research involved 78 patients with chronic erectile dysfunction. Results showed no significant demographic differences between groups, and satisfaction levels were high for both reservoir placements. Although more patients with prevesical reservoirs reported feeling the reservoir, the difference was not statistically significant. The study suggests reservoir location does not significantly impact patient satisfaction, but further research with larger subgroups is needed.

“The take-home message…is it doesn't matter whether you put the reservoir in the ectopic location or the prevesical location. Patients tend to be satisfied in both locations,” said Mohit Khera, MD, MBA, MPH.

Satisfaction compared for IPP reservoir placement in prevesical vs ectopic location

Regenerative treatment including low-intensity shockwave therapy (LiWST) and platelet-rich plasma (PRP) injections, as well as a combination of both, may be efficacious for the treatment of 

In new systematic review and meta-analysis data presented at the 

Sexual Medicine Society of North America (SMSNA) 2024 Fall Scientific Meeting

Regenerative treatments, including low-intensity shockwave therapy (LiSWT) and platelet-rich plasma (PRP) injections, show promise for erectile dysfunction (ED) management. A systematic review and meta-analysis presented at the SMSNA 2024 Fall Scientific Meeting revealed that both therapies, independently and combined, significantly improved International Index of Erectile Function (IIEF) scores compared to control. LiSWT was the most effective standalone treatment, while the combination of LiSWT and PRP showed the greatest improvement. Further research is needed to confirm these findings and explore stem cell therapy's potential.

SMSNA 2024 abstract data show shockwave therapies and platelet-rich plasma, either alone or in combination, may be promising treatments for ED.

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