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128 citation(s) found for "Helo, S".

(028) Changing the Status Quo: A Randomized Controlled Trial Comparing Long-Acting and Short-Active Local Anesthetics for Postoperative Pain Control After Penile Prosthesis Placement
Almohtasib, J, Anians, Wyatt, Parikh, Niki , Kohler, T, Ziegelmann, M., Almohtasib, Jamil , Kohler, Tobias S , Helo, Sevann , Yang, D

Mayo Clinic

The Journal of Sexual Medicine | December 9, 2025 | Volume: 22 | Issue: Supplement_4 | Pages: No page available

10.1093/jsxmed/qdaf320.028 Get It

Abstract Introduction The opioid epidemic has encouraged increased efforts to minimize postoperative opioid use, particularly in urologic procedures. While short-acting local anesthetics are often used in inflatable penile prosthesis (IPP) placement, their effects diminish quickly, potentially leading to higher opioid requirements. Liposomal bupivacaine (LB), a long-acting local anesthetic, may reduce opioid requirements, but its cost and limited prospective data in IPP patients warrant further investigation. Objective To compare the efficacy of long-acting liposomal bupivacaine with short-acting ropivacaine in reducing postoperative pain and opioid consumption following inflatable penile prosthesis (IPP) placement. Methods This randomized controlled trial enrolled adult males undergoing primary IPP placement via a penoscrotal approach. Participants were randomized to receive either LB (20 mL Exparel + 20 mL bupivacaine 0.25%) or ropivacaine (40 mL of 0.5%) as part of a standardized multimodal analgesia protocol. All patients received acetaminophen, gabapentin, and meloxicam perioperatively, with oxycodone prescribed as needed postoperatively (figure 1). The primary outcome was postoperative opioid consumption measured in oral morphine equivalents (OME). Secondary outcomes included pain and anxiety scores assessed on postoperative days (POD) 3, 7, and 14 using visual analog scales. Results Only 13 patients completed the study due to difficulties in recruitment (9 in the long-acting group, 4 in the short-acting group). The long-acting group demonstrated consistently lower opioid consumption at all follow-up points. On POD 3, the median cumulative OME was 7.5 vs. 41.25 in the short-acting group. By POD 14, cumulative OME was 15.0 vs. 93.75. (Figure 2) Pain scores followed a similar pattern, with the long-acting group reporting lower median scores on POD 3 (4 vs. 6) and POD 7 (4 vs. 6). Anxiety scores were also lower in the long-acting group throughout the follow-up. Use of non-opioid analgesics was similar across both groups. Conclusions Despite a limited sample size, this trial showed consistent trends favoring LB over ropivacaine for reducing opioid use and pain following IPP placement. These findings suggest potential clinical benefit but require validation in larger, multicenter studies. The trial also illustrates the difficulty of conducting randomized studies when institutional practices strongly favor one approach. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Endo pharmaceuticals.
Cuff conundrum: inflatable penile prosthesis surgery in men who have transcorporal artificial urinary sphincters
Ungerer, Garrett , Kohler, T, Ziegelmann, M, Elliott, Daniel S. , Helo, Sevann , Ziegelmann, Matthew J, Elliott, Daniel, Ziegelmann, M

Mayo Clinic

The Journal of Sexual Medicine | December 5, 2025 | Volume: 23 | Issue: 2 | Pages: No page available

10.1093/jsxmed/qdaf353 | PMID 41498520 Get It

Abstract Background Concerns exist regarding inflatable penile prosthesis (IPP) placement after transcorporal artificial urinary sphincter (TC-AUS) surgery due to potential risk of damaging the AUS cuff during corporal dilation and device placement. Aim To evaluate perioperative complications, infections, revision rates, and device longevity in patients undergoing IPP placement following prior TC-AUS surgery. Methods We present a case series of men who underwent IPP surgery with an existing TC-AUS in place. A retrospective review was conducted of all patients who underwent TC-AUS placement at a single tertiary institution between 2015 and 2025. Patients who subsequently received IPP surgery were identified. Standard IPP techniques were used with additional precautions to protect the AUS, including use of electrocautery instead of sharp dissection and contralateral reservoir placement. Demographics, operative details, complications, infections, revision events, and device survival were collected through review of operative notes and patient records. Outcomes Primary outcomes included intra-operative difficulties, perioperative complications, infection and erosion rates, and revision or failure rates for both the TC-AUS and IPP devices. Results Among 757 TC-AUS placements, 17 patients subsequently underwent IPP surgery. Seven patients (41%) had a history of pelvic irradiation. The median operative time for IPP placement was 83 minutes (interquartile range [IQR] 68-87), and median follow-up was 31.5 months (IQR 11.2-40.6). All reservoirs were positioned contralateral to the AUS reservoir. A 12 Fr catheter was left postoperatively in 10 patients (59%) for <24 hours. Proximal corporal dilation was noted to be challenging in 3 patients (18%) but dilation was completed without cuff injury or corporal perforation. One patient (6%) had TC-AUS cuff erosion 9.5 months after IPP surgery; one patient (6%) experienced TC-AUS device infection 11.5 months after IPP surgery when his AUD pump eroded through the scrotum. Four patients (24%) developed AUS mechanical failure due to cuff leak at a median of 31.9 months after IPP placement (39.9 months post-AUS). Clinical implications IPP implantation following TC-AUS can be performed safely using careful surgical technique, though vigilance for later AUS mechanical failure is warranted. Strengths and limitations This study represents one of the largest single-institution series evaluating IPP after TC-AUS and includes detailed operative and follow-up data. However, its retrospective design, small cohort size, and limited follow-up duration restrict generalizability. Conclusion IPP placement after TC-AUS appears safe, with low infection and erosion rates, though AUS cuff leaks may occur more frequently than when either device is implanted alone.
Study recruitment challenges when conducting a randomized controlled trial comparing long- and short-acting local anesthetics for pain control after penile prosthesis
Almohtasib, J, Anians, Wyatt, Parikh, Niki , Köhler, Tobias S. , Ziegelmann, Matthew , Almohtasib, Jamil , Helo, Sevann , Ziegelmann, Matthew J, Kohler, Tobias S , Yang, David H.

Mayo Clinic

The Journal of Sexual Medicine | November 15, 2025 | Volume: 23 | Issue: 1 | Pages: No page available

10.1093/jsxmed/qdaf319 | PMID 41240014 Get It

Ceramide test in patients with erectile dysfunction to assess cardiovascular risk
Guillén-Lozoya, A.H. , Dumbrava, Mihai, Bonakdarhashemi, Milad, Kemble, Jayson , Ziegelmann, Matthew , Vasile, Vlad C. , Kopecky, Stephen L. , Köhler, Tobias , Lozoya, Andres Guillen , Helo, Sevann , Collins, Scott, Vasile, Vlad , Kopecky, Stephen, Collins, Scott

Mayo Clinic

The Journal of Sexual Medicine | October 5, 2025 | Volume: 22 | Issue: 10 | Pages: 1750-1756

10.1093/jsxmed/qdaf182 | PMID 41046349 Get It

Abstract Background Erectile dysfunction (ED) is a known precursor and sequela of cardiovascular disease (CVD), with ED severity predicting CVD severity. Aim This study aimed to evaluate the utility of ceramide levels in patients with ED. Methods We initiated ceramide testing in all patients with ED. We retrospectively analyzed ceramide levels from electronic records and stratified by severity of symptoms using the erectile function domain of the International Index of Erectile Function (IIEF). Outcomes The study aimed to determine whether abnormal ceramide levels were associated with ED severity and increased cardiovascular risk. Results Three hundred and fifty-four patients were reviewed, of whom 253 (71.5%) had moderate or higher ED. A statistically significant difference in abnormal ceramide values was found in patients with moderate to severe symptoms, and the odds of getting an abnormal ceramide test were increased based on the IIEF scoring alone (odds ratio [OR] 2.3 [1.04-5.12]; P-value = .034). Clinical Implications Serum ceramide testing could be beneficial in identifying cardiovascular risk in men with ED, potentially prompting cardiac referrals and lifestyle modifications. Strengths and Limitations The strengths of this study include a large sample size and the use of a well-established scale, while the limitations include the retrospective nature of the study and the need for further research to validate the findings. Conclusion Patients undergoing management for ED may benefit from serum ceramide testing and subsequent cardiac referral.
Outcomes following discontinuation of chlorhexidine gluconate in inflatable penile prosthesis surgery: a return to antibiotics for irrigation and dip
Hashemi, Milad Bonakdar , Guillén-Lozoya, A.H. , Ziegelmann, Matthew , Köhler, Tobias S. , Bonakdar Hashemi, Milad, Helo, Sevann , Lozoya, Andres Guillen , Ziegelmann, Matthew J

Mayo Clinic

The Journal of Sexual Medicine | August 26, 2025 | Volume: 22 | Issue: 11 | Pages: 2134-2135

10.1093/jsxmed/qdaf223 | PMID 40973694 Get It

Patient-Reported Barriers to Sex Therapy for Men Referred by Their Urologist: A Pilot Study
Jefferson, Francis A. , Sischka, Michael, Vencill, Jennifer A. , Ziegelmann, Matthew , Britton, Cameron J. , Köhler, Tobias , Collins, C. Scott, Jefferson, Francis, Vencill, Jennifer, Britton, Cameron, Findlay, Bridget, Helo, Sevann , Dumbravă, Mihai , Findlay, Bridget L.

Mayo Clinic

Journal of Sex & Marital Therapy | August 23, 2025 | Volume: 51 | Issue: 7 | Pages: 758-765

10.1080/0092623x.2025.2551838 | PMID 40848043 Get It

Chlorhexidine gluconate application, diabetes, revision surgery, and extended operative time increase risk for penile implant infection
Hashemi, Milad Bonakdar , Ziegelmann, Matthew , Lybbert, Daniel, Piraino, Javier , Lozoya, Andres H Guillen, Köhler, Tobias , Helo, Sevann , Bonakdar Hashemi, Milad, Ziegelmann, Matthew J, Lybbert, Daniel T, Piraino, Javier , Guillen Lozoya, Andres H

Mayo Clinic

The Journal of Sexual Medicine | January 20, 2025 | Volume: 22 | Issue: 3 | Pages: 508-516

10.1093/jsxmed/qdaf009 | PMID 39916374 Get It

Abstract Background Chlorhexidine gluconate (CHG) (0.05%) has recently been suggested as a dip and irrigation solution at time of inflatable penile prosthesis (IPP) surgery. Aim This study evaluated infection rates before and after implementing CHG protocol while investigating concurrent risk factors contributing to post operative infections. Methods A retrospective, consecutive cohort study was performed that included patients who underwent insertion of a Coloplast Titan IPP including both virgin and revision cases between 2021 and 2024. Cases performed from January 2021 to August 2022 utilized rifampin/gentamicin for dip and vancomycin/gentamicin for irrigation (ABX), whereas those from October 2022 to May 2024 utilized CHG for both dip and irrigation. Perioperative risk factors including dip and irrigation solution used at time of surgery were compared between groups. Outcomes We defined the incidence of postoperative infection and risk factors associated with infection in each group. Results The incidence of infection was significantly higher in the 0.05% CHG group (13/377) compared to the ABX group (0/320) (P < .001). When analyzed separately by subgroup, virgin cases treated with CHG for dip and irrigation demonstrated a significantly higher infection rate (7/315) compared to those in the ABX group (0/280) (P = .012). Similarly, in revision cases, the CHG group also exhibited a significantly higher infection rate (0/40) than the ABX group (6/62) (P = .043). Univariable analysis of the CHG cohort identified three significant risk factors for infection: diabetes mellitus (DM), extended operative time (OP), and revision surgery (P = .003, .001, and < .001, respectively). Multivariable regression analysis revealed that patients with DM had a 5.7-fold increased risk of infection (OR: 5.70, P = .004), while those undergoing revision surgery faced a 5.3-fold higher risk (OR: 5.26, P = .004). Additionally, each minute increase in OP was associated with a 1% higher infection risk (OR: 1.01 per minute, P = .007). These associations remained significant after adjusting for all variables in the model. Clinical Implications Prosthetic surgeons should be cautious about adopting 0.05% CHG for both dip and irrigation in the absence of strong clinical evidence demonstrating its non-inferiority to antibiotic solutions. Strengths and Limitations This is the first clinical study reporting infection rates after IPP surgery using 0.05% CHG for both dip and irrigation. While retrospective and non-randomized, we present a relatively large sample size of patients. Conclusions Our findings identify four risk factors for penile prosthesis infection: usage of the 0.05% CHG solution for dip and irrigation solution of Coloplast hydrophilic-coated devices, DM, revision surgery, and extended OP.
(334) EARLY MECHANICAL FAILURE IS RARE BUT AUTO INFLATION IS COMMON AFTER PENILE PROSTHESIS PLACEMENT
Ziegelmann, M, Pinkhasov, Alexandr, Bonakdarhashemi, M, Kohler, T, Ziegelmann, M, Guillen, A, Helo, Sevann , Kohler, T

Mayo Clinic

The Journal of Sexual Medicine | December 11, 2024 | Volume: 21 | Issue: Supplement_7 | Pages: No page available

10.1093/jsxmed/qdae167.322 Get It

Abstract Introduction Penile prosthesis (PP) implantation is associated with high patient satisfaction in patients with medically refractory erectile dysfunction (ED). There remains a paucity in the literature regarding the temporal evolution of patient following PP surgery. Objective We sought to evaluate mechanical-associated outcomes in our Penile prosthesis (PP) cohort. Methods We analyzed our prospective penile registry that includes patient-completed surveys regarding device outcomes administered at 6 and 12-months after PP placement. We specifically examined the questions: “Have you had another [prosthesis] surgery since your first operation?”; and, “Does the device ever inflate or deflate on its own, if Yes how bothersome is this for you on a scale of 1-10 (1- very bothersome, 10 no bother)?”. Chart review was performed to identify pertinent variables including reservoir location (retropubic vs submuscular) and need for prosthesis revision for survey respondents. Results A total of 304 patients were enrolled in the registry. Of these, 101 completed the 6-month assessment and 79 completed the 1-year survey. The vast majority of PP were Coloplast (91.4%) utilizing the “classic” pump. Mean chart review follow up was approximately 3 years. One device was explanted for implant infection. No additional operations were reported for mechanical failure. Auto-inflation (AI) was reported in 38 patients at 6 months and 21 patients at 12 months. AI was most common in patients with submuscular reservoir placement (75.9% of those who reported AI at 6 months and 50% at 12 months respectively). The relative risk of developing AI was doubled in patients with a submuscular reservoir [2.2 (1.05-3.44); p < 0.001)]. Degree of bother had a reported median of 5 (3.75-9) at 6 months and became less bothersome after 12-months year with a reported median of 7 (5-9) (p = 0.230) [Fig. 1]. Conclusions Early Penile prosthesis mechanical failure requiring revision surgery did not occur in our cohort but patient-reported auto-inflation was identified more frequently than previously reported. Further study is warranted, but patients may benefit from pre-operative counseling regarding the incidence of auto-inflation. Disclosure Yes, this is sponsored by industry/sponsor: Coloplast. Clarification: Industry funding only - investigator initiated and executed study.
(228) PARTNER SATISFACTION AFTER PENILE PROSTHESIS PLACEMENT IN PATIENTS WITH ERECTILE DYSFUNCTION
Dumbravă, Mona, Guillén, Alfredo, Ziegelmann, M, Kohler, T, Dumbrava, M, Guillen, A, Pinkhasov, Aaron , Kohler, T, Helo, Sevann

Mayo Clinic

The Journal of Sexual Medicine | December 11, 2024 | Volume: 21 | Issue: Supplement_7 | Pages: No page available

10.1093/jsxmed/qdae167.223 Get It

Abstract Introduction Penile prosthesis (PP) implantation is associated with high patient satisfaction and improved sexual quality of life in medically refractory erectile dysfunction (ED). Despite the current surgical advances and patients’ satisfactions after PP implantation, there has been paucity of data on reported partner satisfaction. We aimed to evaluate changes in partner satisfaction after PP placement. Objective We aimed to evaluate changes in partner satisfaction after PP placement. Methods We initiated a registry of patients undergoing surgery for placement of a PP. After consent, Perioperative study assessments and follow-ups were conducted. After surgery, patients were directed to fulfill a survey at 6 months and 12 months. Patients who fulfilled both items were included in the analysis. Results A total of 304 patients had a PP placement, of these 101 completed the survey. At 6 months, 62 patients (61.4%) reported a moderate to high partner’ satisfaction, and this positive response was sustained at 12-months (82.3%). 73.3% of partner’s reported no-pain after 6 months and this increased to 79.7% after 12 months. 67.3% of partners stated they would recommend the procedure to a friend or family at 6-months. This increased significantly to 84.8% at 12-months (p = 0.012). Conclusions Penile prosthesis placement is associated with high partner satisfaction rates, with a sustained positive perception over time when comparing 6 and 12-month follow-up outcomes. Further study is warranted to assess partner satisfaction after penile prosthesis implantation. Disclosure Yes, this is sponsored by industry/sponsor: COLOPLAST. Clarification: Industry funding only - investigator initiated and executed study.