Sexual Bother Research Articles

Sexual bother and sexual activity before and after kidney transplantation

Among patients awaiting kidney transplantation (KT), sexual dysfunction is common owing to end-stage kidney disease, but may improve post-KT. Leveraging a 2-center prospective study, 2422 adult KT candidates and 490 adult KT recipients (May 2014 to December 2023) were identified. Using the Kidney Disease Quality of Life Short Form, participants reported on the negative impact of sexual dysfunction due to end-stage kidney disease (ie, sexual bother) at KT evaluation, admission, and post-KT follow-ups. Using mixed-effect logistic regression models, we estimated odds and trajectories for odds of sexual bother. At evaluation, 46.1% of male and 29.6% of female candidates reported sexual bother; 39.0% and 34.5%, respectively, had been sexually active in the past 4 weeks. At admission, 53.8% male and 27.0% female recipients reported sexual bother; 41.6% and 41.8%, respectively, had been sexually active in the past 4 weeks. The estimated prevalence of sexual bother decreased during the first 3 years post-KT (odds ratio per year: 0.39; 95% CI: 0.25-0.60). Sexual activity increased and peaked 1-year post-KT. At 3 years post-KT, 48.9% of male and 50.0% of female recipients were sexually active. Sexual bother is common pre-KT and improves post-KT, and sexual activity increases post-KT. Sexual health is important and should be considered during KT management.

Prospective comparative study of quality of life in patients with bladder cancer undergoing cystectomy with ileal conduit or bladder preservation

ObjectiveTo compare health-related quality of life (HRQOL) in patients undergoing radical cystectomy with ileal conduit (RC) or bladder preservation (BP) with (chemo)radiotherapy for bladder cancer.Methods and analysisPatients with bladder cancer,...

Patient Reported Sexual Adaptation Following Prostate Cancer Treatment: An Analysis of Related Variables and Sexual Outcomes Associated with Sexual Adaptation Styles.

Sexual concerns after prostate cancer (PCa) treatment are high. Flexible coping is a crucial element to maintaining sexual activity after PCa and improves adaptation outcomes. We aimed to identify potential sexual adaptation styles reported by men following PCa treatment, and to assess relationships among associated variables and outcomes. Individuals (n = 223) with PCa treatment history (e.g., radical prostatectomy [n = 165, 74.0%], external beam radiation [n = 83, 37.2%], hormone/androgen deprivation therapy [n = 83, 37.2%]), completed an online survey assessing sexual variables and processes of sexual adaptation. Using a combination of inductive and deductive coding, open-ended responses were thematically analyzed and grouped into sexual adaptation styles. Factors potentially associated with sexual adaptation styles (e.g., age, perceived partner involvement, co-morbidities, relationship duration, time since PCa treatment, desire for physical affection, depression, relationship adjustment) were tested using multinomial logistic regression. Outcomes of sexual well-being (sexual distress, sexual bother, sexual satisfaction) and relationship adjustment were compared against each sexual adaptation style using a multivariate analysis of variance. Sexual activity status and satisfaction with the adaptation process was assessed across the sexual adaptation styles using a chi-square analysis and post-hoc tests. Two distinct categories were identified: those who had Adapted (n = 185) and those who had Not Adapted (n = 38). Four sexual adaptation styles emerged in the adapted category: Relationship Renegotiation (n = 53) and Sexual Renegotiation (n = 47), which were couples-focused styles, and Acceptance/Resignation (n = 34) and Masturbation/Erection (n = 48), which were individual-focused styles. Participants who could not be categorized as one style, but rather met several, were identified as Mixed (n = 3). Higher rates of depression, lower relationship adjustment, lack of sexual activity, and greater dissatisfaction with the adaptation process were observed for Not Adapted participants. Participants engaged in any type of adaptation style fared better than those who had Not Adapted. Couples-focused styles tended to emphasize renegotiation, including a changed perspective on the expression of the relationship. Perceived direct engagement of the partner facilitated adaptation and emphasized engagement with flexible coping, either through redefining priorities or ways of being sexual. Individual-focused styles emphasized pre-cancer erectile function, and either aimed to return to capacity for penetrative sexual activity or accepted its inaccessibility and largely an abandonment of partnered sexual activity.

Impact of neoadjuvant relugolix on patient-reported sexual function and bother.

Sexual function following local treatment for prostate cancer is an important quality of life concern. Relugolix is a novel oral GnRH receptor antagonist used in combination with radiation therapy in the treatment of unfavorable prostate cancer. It has been shown to achieve rapid and profound testosterone suppression. As a result, these very low testosterone levels may impact both sexual functioning and perceptions. This prospective study sought to assess neoadjuvant relugolix-induced sexual dysfunction prior to stereotactic body radiation therapy (SBRT). Between March 2021 and September 2023, 87 patients with localized prostate cancer were treated with neoadjuvant relugolix followed by SBRT per an institutional protocol. Sexual function and bother were assessed via the sexual domain of the validated Expanded Prostate Index Composite (EPIC-26) survey. Responses were collected for each patient at pre-treatment baseline and after several months of relugolix. A Utilization of Sexual Medications/Devices questionnaire was administered at the same time points to assess erectile aid usage. The median age was 72 years and 43% of patients were non-white. The median baseline Sexual Health Inventory for Men (SHIM) score was 13 and 41.7% of patients utilized sexual aids prior to relugolix. Patients initiated relugolix at a median of 4.5 months (2-14 months) prior to SBRT. 95% and 87% of patients achieved effective castration (≤ 50 ng/dL) and profound castration (< 20 ng/dl) at SBRT initiation, respectively. Ability to have an erection, ability to reach orgasm, quality of erections, frequency of erections, and overall sexual function significantly declined following relugolix. There was a non- significant increase in sexual bother. In concordance with known side effects of androgen deprivation therapy (ADT), neoadjuvant relugolix was associated with a significant decline in self-reported sexual function. However, patients indicated only a minimal and non-significant increase in bother. Future investigations should compare outcomes while on relugolix directly to GnRH agonist-induced sexual dysfunction.

(121) Acceptant and Commitment Therapy to Increase Compliance to Sexual Dysfunction Treatments in Men with Prostate Cancer: 6- and 12-Month Data from a Randomized Controlled Trial

Abstract Introduction For many men with prostate cancer, difficulty with sexual dysfunction, in particular erectile dysfunction (ED), can trigger a psychological process which leads to avoidance of utilizing sexual dysfunction treatments. Objective This study tests a novel psychological intervention based on Acceptance and Commitment Therapy (ACT) concepts to help men utilize these treatments. Methods This ongoing study recruited men with prostate cancer starting intracavernosal injection therapy (ICIT) for the treatment of ED. The recruitment goal is N=220. Subjects are randomized to ICIT + ACT (ACT), which focuses on reducing avoidance, or ICIT + Enhanced Monitoring and Education (EME), which includes enhanced follow-up. Both groups receive ICIT plus 3 sessions (30–45 min) and 10 booster sessions (10 min). The interventions are delivered over the course of a year. Subjects are assessed at entry and every 6 months (m) for two years. The primary outcomes are the number of penile injections/week (verified by syringe count), and compliance (defined as ≥2 injections/week). Secondary outcomes assess psychosexual variables. Preliminary 6m and 12m data is presented. Since these are preliminary analyses, effect sizes (d) are reported for secondary variables (d=0.2, small effect; d=0.5, medium effect; d=0.8, large effect). Results To date, 191 subjects have been randomized; 112 have completed the 6m assessment (ACT n=57, EME n=55) and 97 completed the 12m assessment (ACT n=48, EME n=49). Mean age at baseline was 60±7 years. At 6m and 12m, the ACT group utilized more injections/week vs. the EME group (6m: median 1.8 vs. 1.2, p=0.01; 12m: median 2.0 vs. 1.4, p=0.01) and were more compliant with ICI vs. the EME group (6m: 65% vs. 35%, p=0.01, RR=1.86; 12m: 79% vs. 41%, p=0.01, RR=1.93). At 6m and 12m, the ACT group reported greater: satisfaction with ED treatment (d=0.6) and overall sexual relationship (d=0.2). The ACT group also reported lower: sexual bother (d=0.2), prostate cancer treatment regret (d=0.3), negative psychological impact of cancer (d=0.3), and depressive symptoms (d=0.4). Conclusions Preliminary analysis suggests ACT significantly increases ICI use. Data also indicate that ACT helps increase men’s satisfaction with injections and sexual relationship, while reducing sexual bother, prostate cancer treatment regret, the psychological impact of cancer, and depressive symptoms. Disclosure No.

A systematic review of the patient reported outcomes that affect patients with muscle invasive bladder cancer after radical cystectomy and urinary diversion.

To determine the functional domains and symptom scales that affect patients most following radical cystectomy (RC) and urinary diversion (UD), and if a single instrument (or combination) adequately captures these bothersome symptoms. It is unclear whether current patient reported outcome (PRO) instruments that have been used to assess quality of life in patients following RC and UD adequately cover the most bothersome symptoms affecting patients. A systematic search of MEDLINE, EMBASE, PubMed, Cinahl and Cochrane was conducted from January 2000 to May 2023 for original articles of patients who had RC and UD since 2000 for muscle invasive bladder cancer. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) process was followed. Extracted data included the PRO measures used, domains reported and scores in the first 12 months post-surgery (short-term) and after 12 months (long-term). A conservative threshold of <70 for functional domains and >30 for symptom domains was used to determine which PRO domains were potentially concerning to patients in each study. Quality assessment was performed using the QUALSYST appraisal tool. Thirty-five studies met the inclusion criteria, including a total of eight unique PRO instruments. The main findings indicated that physical function was the most concerning PRO for patients with both neobladder (NB) and ileal conduit (IC) in the short and long term. Additionally, bowel, urinary and sexual bother were concerning symptoms for patients with NB in the long-term, but only in the short-term for those with IC. The main issues are adequately addressed using the combination of EORTC QLQ-C30 and QLQ-BLM30 instruments.

The association between pre‐diagnostic levels of psychological distress and adverse effects after radical prostatectomy

AbstractObjectivesTo prospectively analyse the associations between pre‐diagnostic levels of anxiety and depression and patient‐reported urinary and sexual adverse effects after radical prostatectomy in a population‐based setting.Patients and MethodsIn three Norwegian county hospitals, men referred with a suspicion of prostate cancer were asked to fill out a patient‐reported outcome measurement (PROM) questionnaire prior to prostate biopsy. Those who later underwent radical prostatectomy were stratified into three distress groups according to their Hopkins Symptom Checklist 5‐score. Additional PROM questionnaires, including the EPIC‐26 to measure adverse effects, were collected at 6 and 12 months postoperatively. Multivariable mixed models were estimated and post hoc pairwise comparisons performed to explore differences in adverse effects between distress groups.ResultsA total of 416 men were included at baseline and of those, 365 (88%) returned questionnaires at 6 months and 360 (87%) at 12 months. After adjusting for confounders, men with high distress at baseline had worse urinary incontinence domain score (58.9 vs. 66.8, p = 0.028), more urinary bother (64.7 vs. 73.6, p = 0.04) and a higher risk of using incontinence pads (70.6% vs. 54.2%, p = 0.034) at 6 months than those with low distress. There was no difference in the sexual domain scores between distress groups postoperatively, but the high‐distress group expressed more sexual bother (24.9 vs. 37.5, p = 0.015) and the intermediate‐distress group had a greater probability of using sexual medications or devices (63.8% vs. 50.0%, p = 0.015) than the low‐distress group at 6 months. At 12 months scores generally improved slightly and differences between distress groups were less evident.ConclusionMen with higher levels of anxiety and depression before prostate biopsy report more urinary and sexual adverse effects after radical prostatectomy. This should be considered both in treatment decision‐making and during follow‐up after radical prostatectomy.

A psychoeducational intervention to improve sexual functioning in male rectal and anal cancer patients: A pilot randomized controlled trial study.

Male rectal and anal cancer patients demonstrate high rates of sexual dysfunction. This pilot randomized controlled trial tested a psychoeducational intervention designed to improve psychosexual adjustment. Rectal or anal cancer patients were randomized to a Sexual Health Intervention for Men (intervention) or to a referral and information control (control). The intervention included control activities plus 4 sexual health intervention sessions every 4-6 weeks and 3 brief telephone calls timed between these sessions. Assessments were completed pre-intervention (baseline) and 3 months (follow-up 1) and 8 months (follow-up 2) post-intervention. Differences were assessed with statistical significance and Cohen's d effect sizes (d = 0.2, small effect; d = 0.5, moderate effect; d = 0.8, large effect). Ninety subjects enrolled. Forty-three participants completed at least 1 follow-up assessment (intervention, n = 14; control n = 29). At follow-up 1, men in intervention, compared to control, improved on all domains of the International Index of Erectile Function (IIEF) (p < 0.001 to p < 0.05) and demonstrated large effects (d = 0.8 to d = 1.5). Similarly, at follow-up 2, changes in all domains of the IIEF except the orgasm domain were either statistically significant or marginally statistically significant (p = 0.01 to p = 0.08) and demonstrated moderate to large treatment effects for intervention versus control (d = 0.5 to d = 0.8). Men in the intervention, compared to control, demonstrated decreased sexual bother at follow-up 1 (p = 0.009, d = 1.1), while Self-Esteem and Relationship (SEAR) total scores and the SEAR sexual relationship subscale demonstrated moderate increases for intervention versus control (d = 0.4 to d = 0.6). This study provides initial evidence for combining a psychoeducational intervention with medical interventions to address sexual dysfunction following rectal and anal cancer. Trials register number: NCT00712751 (date of registration: 7/10/2008).

Prospective Comparative Study of Quality of Life in Bladder Cancer Patients Undergoing Cystectomy or Bladder Preservation

Health-related Quality of life (HRQOL) may be decisive when different treatments yield comparable survival outcomes. We compared QOL in patients undergoing radical cystectomy with ileal conduit (RCIC) or bladder preservation (BP) with (chemo)radiotherapy for bladder cancer. Patients with histological diagnosis of bladder cancer, stage T1-T4, N0-N1, M0 with a minimum follow-up of 6 months from the last treatment intervention (RCIC or BP) and alive without disease at the time of QOL assessment were eligible for inclusion. After ethics committee approval, two HRQOL instruments were translated, validated and administered: Bladder cancer index (BCI) for bladder cancer-specific HRQOL, which includes 36 items under three domains - bladder, bowel and sexual function and the EORTC QLQ C30 which includes 30 items under three domains - functional, symptom and global health. The mean QOL scores across various domains and specific questions were compared between the two treatment groups using the independent t-test. Of the 104 patients enrolled, 56 had RCIC, and 48 received BP, and included 95 (91.3%) males. The median time from treatment completion to QOL assessment was 22 months (IQR 10-56). The median age for the entire cohort was 62 years (IQR 55-68), 65.5 years (IQR 55-71) in BP and 59.5 years (IQR 55-66) in RCIC. Overall, mean BCI urinary scores and bowel scores were high in both groups, with no significant difference in function or bother subdomains between the two groups (Table 1). Overall, BCI sexual scores were low in both the groups but significantly better after BP (BPmean 56.9, RCICmean 41.5, p = 0.01). Mean scores for sexual function BPmean 38.4 and RCIC mean 25 p (0.07) and sexual bother BPmean 81 RCICmean 62 (p 0.02) subdomains. There was no significant difference in EORTC QOL outcomes in functional (BPmean 91.4, RCICmean 88.7 p 0.23), symptom (BPmean 89.8, RCICmean 89, p = 0.68) and global health scale (BPmean 76.8, RCICmean 78.5, p = 0.69) in both groups. On question-wise assessment, the ability to perform an exercise (BPmean 94.2, RCICmean 85, p = 0.06) and urinary leakage at night time (BPmean 91.7, RCICmean 77.6, p = 0.01) were better in the BP group, while scores for blood in the urine (BPmean 89.1, RCICmean 97, p = 0.05) were better in the RCIC group compared to BP. Overall, QOL was good in both groups in the urinary and bowel domains while it was low in the sexual domain. However, bladder preservation performed significantly better in the sexual domain than RCIC.

Longitudinal variability in symptom burden for patients with prostate cancer (PC).

e17019 Background: Patients with PC often live for many years and can experience burdensome symptoms associated with PC and its treatment. The longitudinal fluctuations in symptom burden for a given individual with PC, or for groups with different PC disease states, are not well-described. We assessed self-rated performance status (PS), pain interference with daily activities, bother from sexual dysfunction, depression, and anxiety symptoms longitudinally for a cohort of patients with PC. Methods: For one year, patients with PC and ≥1 Urology or Medical Oncology clinic visit in the prior 6 months were emailed surveys every 60 days containing the ECOG PS instrument (range 0-4, higher scores = worse PS), PROMIS Pain Interference Short Form 4a (normalized range 1-5, higher scores = greater pain interference), PROMIS Sexual Bother (Male) items SFBOT 204, 205, and 206 (normalized range 1-5, higher scores = greater bother), PHQ-9 depression scale (range 0-27, score ≥10 considered positive for moderate symptoms), and GAD-7 anxiety scale (range 0-21, score ≥10 considered positive for moderate symptoms). We used chart review to obtain baseline characteristics and one-way ANOVA for comparisons. Results: For 201 enrolled patients, mean (SD) number of surveys completed was 5.8 (1.8) over a mean (SD) of 10.6 (3.1) months. At baseline, 50.7% had localized PC (LPC), 18.9% biochemically recurrent PC (BCR-PC), and 30.3% metastatic PC (MPC). 40.8% of patients were on androgen deprivation therapy, which was not associated with greater sexual bother (p = 0.17). Mean (SD) values for ECOG PS, pain interference, sexual bother, the PHQ-9, and the GAD-7 are shown by PC disease state (Table). For patients who completed ≥2 surveys (N = 192), mean (SD) ranges for these scales were 0.4 (0.6), 0.8 (0.9), 1.2 (0.8), 3.7 (3.3), and 2.6 (2.6), respectively. Mean range differed by PC disease state for ECOG PS (0.31 LPC vs 0.63 BCR-PC vs 0.59 MPC, p = 0.003) and pain interference (0.63 LPC vs 1.02 BCR-PC vs 0.95 MPC, p = 0.03). For patients with ≥1 positive PHQ-9 (N = 36) or GAD-7 (N = 11) screen over ≥2 surveys, a mean (SD) of 41% (30%) and 39% (33%), respectively, of their total screens were positive. Mean (SD) ranges for these patients were 8.4 (3.6) for the PHQ-9 and 8.5 (3.4) for the GAD-7 (both p &lt; 0.001 compared with those who never screened positive). Conclusions: Patients with more advanced PC had worse PS, pain, and depression, but those with BCR-PC reported greater longitudinal fluctuations in PS and pain. Patients who screened positive for depression or anxiety only did so in ~40% of their surveys, and had greater longitudinal variability in their PHQ-9/GAD-7 scores than those who never screened positive. [Table: see text]

PD11-01 ACCEPTANT AND COMMITMENT THERAPY TO INCREASE COMPLIANCE TO SEXUAL DYSFUNCTION TREATMENTS IN MEN WITH PROSTATE CANCER: 6- AND 12-MONTH DATA FROM A RANDOMIZED CONTROLLED TRIAL

You have accessJournal of UrologyCME1 Apr 2023PD11-01 ACCEPTANT AND COMMITMENT THERAPY TO INCREASE COMPLIANCE TO SEXUAL DYSFUNCTION TREATMENTS IN MEN WITH PROSTATE CANCER: 6- AND 12-MONTH DATA FROM A RANDOMIZED CONTROLLED TRIAL Christian Nelson, Nassima Boukhalfa, Hayley Pessin, Nisha Mehta, Elizabeth Schofield, and John Mulhall Christian NelsonChristian Nelson More articles by this author , Nassima BoukhalfaNassima Boukhalfa More articles by this author , Hayley PessinHayley Pessin More articles by this author , Nisha MehtaNisha Mehta More articles by this author , Elizabeth SchofieldElizabeth Schofield More articles by this author , and John MulhallJohn Mulhall More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003251.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: For many men with prostate cancer, difficulty with sexual dysfunction, in particular erectile dysfunction (ED), can trigger a psychological process which leads to avoidance of utilizing sexual dysfunction treatments. This study tests a novel psychological intervention based on Acceptance and Commitment Therapy (ACT) concepts to help men utilize these treatments. METHODS: This ongoing study recruited men with prostate cancer starting intracavernosal injection therapy (ICIT) for the treatment of ED. The recruitment goal is N=220. Subjects are randomized to ICIT + ACT (ACT), which focuses on reducing avoidance, or ICIT + Enhanced Monitoring and Education (EME), which includes enhanced follow-up. Both groups receive ICIT plus 3 sessions (30-45 min) and 10 booster sessions (10 min). The interventions are delivered over the course of a year. Subjects are assessed at entry and every 6 months (m) for two years. The primary outcomes are the number of penile injections/week (verified by syringe count), and compliance (defined as ≥2 injections/week). Secondary outcomes assess psychosexual variables. Preliminary 6 m and 12 m data is presented. Since these are preliminary analyses, effect sizes (d) are reported for secondary variables (d=0.2, small effect; d=0.5, medium effect; d=0.8, large effect). RESULTS: To date, 191 subjects have been randomized; 112 have completed the 6m assessment (ACT n=57, EME n=55) and 97 completed the 12 m assessment (ACT n=48, EME n=49). Mean age at baseline was 60±7 years. At 6 m and 12 m, the ACT group utilized more injections/week vs. the EME group (6 m: median 1.8 vs. 1.2, p=0.01; 12 m: median 2.0 vs. 1.4, p=0.01) and were more compliant with ICI vs. the EME group (6 m: 65% vs. 35%, p=0.01, RR=1.86; 12 m: 79% vs. 41%, p=0.01, RR=1.93). At 6 m and 12 m, the ACT group reported greater: satisfaction with ED treatment (d=0.6) and overall sexual relationship (d=0.2). The ACT group also reported lower: sexual bother (d=0.2), prostate cancer treatment regret (d=0.3), negative psychological impact of cancer (d=0.3), and depressive symptoms (d=0.4). CONCLUSIONS: Preliminary analysis suggests ACT significantly increases ICI use. Data also indicate that ACT helps increase men’s satisfaction with injections and sexual relationship, while reducing sexual bother, prostate cancer treatment regret, the psychological impact of cancer, and depressive symptoms. Source of Funding: National Institutes of Health: R01 CA 190636 © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e332 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Christian Nelson More articles by this author Nassima Boukhalfa More articles by this author Hayley Pessin More articles by this author Nisha Mehta More articles by this author Elizabeth Schofield More articles by this author John Mulhall More articles by this author Expand All Advertisement PDF downloadLoading ...

PACE-A: An international phase 3 randomised controlled trial (RCT) comparing stereotactic body radiotherapy (SBRT) to surgery for localised prostate cancer (LPCa)—Primary endpoint analysis.

298 Background: People presenting with early-stage LPCa have several treatment options. There is therapeutic equipoise with lack of randomised evidence for superiority of radiotherapy or surgery. PACE-A aimed to determine if there is improved quality of life (QoL) following SBRT compared to surgery. Methods: PACE (NCT01584258) is a phase 3 open-label multiple-cohort RCT. In PACE-A, people with LPCa, T1-T2, Gleason≤3+4, PSA≤20ng/mL &amp; suitable for surgery were randomised (1:1) to SBRT or surgery. SBRT dose was 36.25Gy/5 fractions in 1-2 weeks; surgery was laparoscopic or robotically assisted prostatectomy. Androgen deprivation was not permitted. Co-primary endpoints were patient reported outcomes (PROs) of Expanded Prostate Index Composite (EPIC-26) questionnaire number of absorbent pads per day &amp; EPIC bowel subdomain score at 2 years. Target sample size was 234 participants (pts) to detect 9% difference in urinary incontinence (80% power, 5% 2-sided alpha) &amp; 5-point difference in mean bowel subdomain score (90% power, 5% 2-sided alpha) with higher EPIC score (range 0-100) indicating better QoL. Secondary endpoints included clinician reported toxicity and additional PROs (1% significance level). Analysis is by treatment received. Results: From Aug 2012 to Feb 2022, 123 men from 10 UK centres were randomised. The IDMC advised stopping recruitment after a 2-year gap in during COVID. Pts had median age 66years (IQR: 61, 69), median PSA 8ng/ml (6, 11) with 52% tumours ≥T2b and 79% Gleason 3+4; 93% pts were of white race. 58/63 pts received SBRT as allocated (2 received surgery, 2 unknown, 1 withdrawn); 48/60 received surgery as allocated (1 received SBRT, 3 received CRT, 2 unknown, 6 withdrawn). 8 laparoscopic and 42 robotic assisted operations were performed. Median follow-up is 50 months (IQR 41, 74). At 2 years, fewer SBRT pts reported use of urinary pads: 2/43 (4.5%) vs 15/32 (46.9%), p&lt;0.001. SBRT pts had significantly worse bowel subdomain score (mean (SD) 88.4 (12.7) vs 97.3 (5.5), p&lt;0.001). 7/45 (15.6%) SBRT and 0/31 (0%) surgery pts reported moderate/big problem with bowel symptoms (p=0.04). SBRT pts reported less EPIC sexual subdomain score (58.0 (31.9) vs 29.3 (20.5), p&lt;0.001); there was no evidence of a difference in urinary subdomain score (85.5 (19.8) vs 80.5 (20.8), p=0.29). At 2 years, CTCAE genitourinary grade 2 or higher(G2+) toxicity was seen in 5/54 (9.3%) SBRT vs 4/42 (9.5%) surgery pts (p=0.97); there was no G2+ gastrointestinal (GI) events seen in either group. Conclusions: PACE-A contributes the first randomised data to the comparison of SBRT with surgery in LPCa providing PRO data relevant to informed decision making. Compared to surgery, pts receiving SBRT had better urinary continence &amp; sexual bother score; clinician reported GI toxicity was low but SBRT pts reported more bowel bother at 2 years. Clinical trial information: NCT01584258 .

Patient-reported outcomes after robot-assisted radical prostatectomy and institutional learning curve for functional outcomes

The study was performed to examine patient-reported outcomes (PROs) in the 1st year after surgery and the institutional learning curve after the introduction of robot-assisted radical prostatectomy (RARP). The subjects were 320 consecutive patients who underwent RARP from 2014 to 2018. These cases were divided into three groups treated in the early, middle, and late periods, with about 100 cases in each. PROs were recorded using the Expanded Prostate Cancer Index Composite (EPIC). There were no significant differences among the early, middle, and late periods based on EPIC scores. Urinary function and bother decreased in the 1st month after surgery, and gradually recovered thereafter. However, urinary function was significantly worse in the 1st year after surgery than at baseline. Urinary function and bother were better in patients treated with nerve-sparing surgery, and in nerve-sparing cases, urinary function and bother were best in the early period and worst in the late period. These cases also had the best score for sexual function in the early period, but sexual bother was worst in the early period. In contrast, in cases treated without nerve-sparing surgery, urinary function and bother were best in the late period and worst in the early period, although without significant differences. The functional results of this study based on PROs are useful for providing information for patients. Interestingly, the institutional learning curves for RARP differed in cases that did and did not undergo a nerve-sparing procedure.

The effect of race on treatment patterns and subsequent health-related quality of life outcomes in men undergoing treatment for localized prostate cancer.

Racial differences in Health-Related Quality of Life (HRQoL) after treatment of prostate cancer (PCa) are not well studied. We compared treatment patterns and HRQoL in African American (AA) and non-AA men undergoing active surveillance (AS), radical prostatectomy (RP), or radiation (XRT). Men diagnosed with PCa from 2007-2017 in the Center for Prostate Disease Research Database were identified. HRQoL was evaluated using Expanded PCa Index Composite and SF-36 Health Survey. In 1006 men with localized PCa, 223 (22.2%) were AA (mean follow up 5.2 yrs). AA men with low-risk disease were less likely to undergo AS (28.5 vs. 38.8%) and more likely to undergo XRT (22.3 vs. 10.6%) than non-AA men, p < 0.001. In intermediate-risk disease, AA received more XRT (43.0 vs. 26.9%) and less RP (50.5 vs 66.8%), p = 0.016. In all men, RP resulted in worse urinary function and sexual HRQoL compared to AS and XRT. Bowel HRQoL did not vary by treatment in AA men, however, in non-AA men, XRT resulted in worse bowel scores than AS and RP. HRQoL was then compared for each treatment modality. AA men had worse sexual bother (p = 0.024) after RP than non-AA men, No racial differences were found in urinary, bowel, hormonal, or SF-36 scores for men undergoing AS, RP or XRT. AA men are less often treated with AS for low-risk disease and are more likely to undergo XRT. AA men experience worse sexual bother after RP, however, the effect of XRT on bowel symptoms is worse in non-AA men.

Patient-reported functional outcome measures and treatment choice for prostate cancer

BackgroundThe aim of this study was to describe changes in patient-reported functional outcome measures (PROMs) comparing pre-treatment and 12 months after radical prostatectomy (RP), external beam radiation therapy (EBRT), brachytherapy and active surveillance (AS).MethodsMen enrolled from 2010 to 2019 in the South Australian Prostate Cancer Clinical Outcomes Collaborative registry a prospective clinical registry were studied. Urinary, bowel, and sexual functions were measured using Expanded Prostate Cancer Index Composite (EPIC-26) at baseline and 12 months post-treatment. Higher scores on the EPIC-26 indicate better function. Multivariable regression models were applied to compare differences in function and extent of bother by treatment.ResultsOf the 4926 eligible men, 57.0% underwent RP, 20.5% EBRT, 7.0% brachytherapy and 15.5% AS. While baseline urinary and bowel function varied little across treatment groups, sexual function differed greatly (adjusted mean scores: RP = 56.3, EBRT = 45.8, brachytherapy = 61.4, AS = 52.8; p < 0.001). Post-treatment urinary continence and sexual function declined in all treatment groups, with the greatest decline for sexual function after RP (adjusted mean score change − 28.9). After adjustment for baseline differences, post-treatment sexual function scores after EBRT (6.4; 95%CI, 0.9–12.0) and brachytherapy (17.4; 95%CI, 9.4–25.5) were higher than after RP. Likewise, urinary continence after EBRT (13.6; 95%CI, 9.0-18.2), brachytherapy (10.6; 95%CI, 3.9–17.3) and AS (10.6; 95%CI, 5.9–15.3) were higher than after RP. Conversely, EBRT was associated with lower bowel function (− 7.9; 95%CI, − 12.4 to − 3.5) than RP. EBRT and AS were associated with lower odds of sexual bother (OR 0.51; 95%CI, 0.29–0.89 and OR 0.60; 95%CI, 0.38–0.96, respectively), and EBRT with higher odds of bowel bother (OR 2.01; 95%CI, 1.23–3.29) compared with RP.ConclusionThe four common treatment approaches for prostate cancer were associated with different patterns of patient-reported functional outcomes, both pre- and 12 months post-treatment. However, after adjustment, RP was associated with a greater decline in urinary continence and sexual function than other treatments. This study underscores the importance of collecting baseline PROMs to interpret post-treatment functional outcomes.

Acceptance and commitment therapy to increase compliance to intracavernosal injection use (ICI) following radical prostatectomy (RP): Preliminary results from a randomized control trial

ABSTRACT Introduction ICI is the cornerstone of many erectile rehabilitation programs (ERP). However, compliance with ICI is historically low. This study tests a novel psychological intervention based on Acceptance and Commitment Therapy (ACT) concepts to help men reduce avoidance to ICI and commit to an ERP. Methods This ongoing study recruits men starting in our ERP. The recruitment goal is N=220. Subjects are randomized to ERP+ACT or ERP+Enhanced Monitoring and Education (EME). ERP+ACT receive ERP plus 3 ACT Sessions (30-45min) and 10 ACT Booster Sessions (10min). ERP+EME receive ERP plus 3 EME Sessions (30-45min) and 10 EME Booster Sessions (10min) delivered by a nurse practitioner who monitors ICI use, answers questions, and provides education. The interventions are delivered over a year. Eligibility includes: within 9m post RP; functional pre-RP erections (≥6/10). Subjects are assessed at entry and every 6m for two years. The primary outcomes are number of penile injections/week (verified by syringe count), and compliance (defined as ≥2 injections/week). Secondary outcomes are: ED treatment satisfaction, sexual self-esteem and relationship quality, sexual bother, prostate cancer treatment regret, the psychological impact of cancer, and depressive symptoms. Preliminary 6m data is presented. Groups are compared with ANCOVA. Since these are preliminary analyses, if differences were not statistically significant, effect sizes (d) are reported (d=0.2, small effect; d=0.5, medium effect; d=0.8, large effect). Results To date, 120 subjects have been randomized; 62 have completed the 6m assessment (ACT n=33, EME n=29). The mean age was 60±7 years and 81% were married. The mean erectile function grade pre-RP was 8.9±1 (0-10 scale). At 6m, the ACT group utilized more injections/week vs. the EM group (median: 2.06 vs. 1.17, p=0.01) and were more compliant with ICI vs. the EM group (70% vs. 45%, p=0.05, RR=1.55). The ACT group reported greater: satisfaction with ED treatment (d=0.6) and overall sexual relationship (d=0.2). The ACT group also reported lower: sexual bother (d=0.2), prostate cancer treatment regret (d=0.3), negative psychological impact of cancer (d=0.3), and depressive symptoms (d=0.2). Conclusion Preliminary analysis suggests ACT significantly increases ICI use. Data also indicate ACT helps increase men's satisfaction with injections and sexual relationship, while reducing sexual bother, prostate cancer treatment regret, the psychological impact of cancer, and depressive symptoms. Source of funding National Institutes of Health: R01 CA 190636 Disclosure Work supported by industry: no.

MP15-01 LONGITUDINAL PATIENT-REPORTED OUTCOMES MEASURES DEMONSTRATE CONTINUED IMPROVEMENTS IN URINARY AND ERECTILE FUNCTION AFTER RADICAL PROSTATECTOMY THROUGH 30 MONTHS

You have accessJournal of UrologyCME1 May 2022MP15-01 LONGITUDINAL PATIENT-REPORTED OUTCOMES MEASURES DEMONSTRATE CONTINUED IMPROVEMENTS IN URINARY AND ERECTILE FUNCTION AFTER RADICAL PROSTATECTOMY THROUGH 30 MONTHS Daniel Frendl, Wesley Chou, Matthew Wszolek, Francis McGovern, Adam Feldman, Michael Blute, Jeffrey Twum-Ampofo, Marcela del Carmen, Marilyn Heng, Rachel Sisodia, and Douglas Dahl Daniel FrendlDaniel Frendl More articles by this author , Wesley ChouWesley Chou More articles by this author , Matthew WszolekMatthew Wszolek More articles by this author , Francis McGovernFrancis McGovern More articles by this author , Adam FeldmanAdam Feldman More articles by this author , Michael BluteMichael Blute More articles by this author , Jeffrey Twum-AmpofoJeffrey Twum-Ampofo More articles by this author , Marcela del CarmenMarcela del Carmen More articles by this author , Marilyn HengMarilyn Heng More articles by this author , Rachel SisodiaRachel Sisodia More articles by this author , and Douglas DahlDouglas Dahl More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002544.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Patient-reported outcomes measures (PROMs) are critical for tracking quality of life and functional outcomes. Urinary incontinence and sexual dysfunction are common adverse effects experienced after radical prostatectomy (RP). PROMs may help inform patients about expected recovery after RP. We assess long-term patient-reported return of urinary and sexual function after RP in routine practice. METHODS: The Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) questionnaire was administered to all patients who underwent RP at our institution in 2016-2017. Questionnaires were administered preoperatively and up to 30 months postoperatively. Primary outcomes of interest were postoperative return of urinary and sexual function, respectively defined as either no urinary pads or use of one pad per day without overall urinary bother, and either erections sufficient for intercourse or erections sufficient for masturbation/foreplay without overall sexual bother. We used Kaplan-Meier estimators to evaluate time to return of these outcomes. RESULTS: Of 634 patients who underwent RP, we included 392 who completed ≥1 questionnaire; 184/392 (47%) had preoperative and postoperative responses. The mean age was 62.4 years (SD 6.5), with 93% of patients having a nerve-sparing surgery and 38% having pathologic extracapsular (≥T3a) disease (Table 1). At 12 months, unadjusted Kaplan-Meier estimates for cumulative likelihood of return of urinary function was 55%, improving to 98% by 30 months (Fig. 1A). For patients with good baseline sexual function who underwent nerve-sparing surgery, 24% reported return of sexual function by 12 months, improving to 71% at 30 months (Fig. 1B). CONCLUSIONS: Routine electronic solicitation of PROMs in our practice showed continued improvements in continence and sexual function up to 30 months postoperatively. These findings may help inform patients regarding typical functional recovery trajectories after RP. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e241 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Daniel Frendl More articles by this author Wesley Chou More articles by this author Matthew Wszolek More articles by this author Francis McGovern More articles by this author Adam Feldman More articles by this author Michael Blute More articles by this author Jeffrey Twum-Ampofo More articles by this author Marcela del Carmen More articles by this author Marilyn Heng More articles by this author Rachel Sisodia More articles by this author Douglas Dahl More articles by this author Expand All Advertisement PDF DownloadLoading ...

Initial Validation of the Radical Prostatectomy Questionnaire (RPQ): A New Patient Reported Outcome (PRO) to Assess Sexual Function following Radical Prostatectomy (RP)

ABSTRACT Introduction The only PRO validated for men after RP is Extended Prostate Cancer Index (EPIC). However, EPIC has weaknesses, including the lack of assessment of function in response to ED medication use, inclusion of ejaculation and absence of penile morphology assessment. We developed the RPQ to address these weaknesses. Methods RPQ is a 41-item scale assessing 5 domains: erectile function (EF), sexual desire (SD), orgasm (O), sexual satisfaction (SS), and penile morphology (PM). The EF domain assesses erections in response to no medication, PDE5i, intracavernosal injections (ICI). We used a multi-step process to develop the RPQ including: extensive literature review; development of primary domains; item generation and winnowing; feedback from 8 sexual medicine experts; and cognitive interviewing with 10 patients to verify content, wording, and response format. For validation, post-RP men completed the RPQ and the following PROs: IIEF, EPIC, SEAR, and the PROMISE measures. Participants completed the RPQ again within two weeks. Analyses include internal consistency (Cronbach's alpha), test-retest reliability, and convergent/discriminant validity. Cronbach's alpha and test-retest reliability ≥0.7 were considered acceptable. Results Mean age of the 311 men was 62±7. All domains of the RPQ demonstrated strong internal consistency (Cronbach's alpha=0.70-0.98) and test-retest reliability (ICC= 0.82-0.99). There was sound convergent validity for the RPQ EF domains with/without medication demonstrate by correlations with the IIEF Erectile Function Domain (EFD) (r=0.31 to 0.70, p&amp;lt;.05). Discriminate validity was demonstrated for RPQ EF domains with/without medication with moderate correlations with the SEAR and PROMIS scales (r=0.23 to r=0.59, p&amp;lt;.01). There was also sound convergent validity for RPQ SD, O, and SS domains with strong correlations with the PROMIS desire, orgasm, and satisfaction scales (r=0.66 to r=0.77, p&amp;lt;.01), with discriminant validity demonstrating moderate correlations with SEAR Self-Esteem (r=0.38 to r=0.46, p&amp;lt;.01) and Sexual Bother (r=-0.43 to 0.66, p&amp;lt;.01). The RPQ PM domain demonstrated convergent validity with moderate correlations with the IIEF EFD and Orgasm domain (r=-0.20; r=0.33, p&amp;lt;.01, respectively) and discriminant validity with low, non-significant correlation with EPIC Urinary function. Conclusion Initial validation of the RPQ supports the reliability and validity of the scale. Disclosure Work supported by industry: no.

Surveillance of sexual function after Robot-assisted laparoscopic radical prostatectomy

ABSTRACT Introduction and Objectives Sexual dysfunction is one of the main factors that affects for quality of life (QOL) after prostatectomy. Previous research showed that sexual dysfunction after laparoscopic radical prostatectomy (LRP) was caused at 1 month, and refractory sexual dysfunction persisted for a long time. In recent years, robot-assisted laparoscopic radical prostatectomy (RALP) has been introduced at a large number of medical facilities. This time, we investigated change of sexual function after RALP using questionnaires related to sexual function. Materials and Methods Thirty-two patients were diagnosed localized prostate cancer and underwent RALP between January 2020 and June 2021 at our hospital. We investigated the change of sexual and voiding functions using International Index of Erectile Function (IIEF5), Expanded Prostate Cancer Index Composite (EPIC) at the time of diagnosis, 1, 3, 6, 12 month after RALP, and daily use numbers of urinary pad at 1, 3, 6, 12 month after RALP. Control was set at the time of diagnosis. This study was approved by the Ethics Committee of our facility (Approval No.3906-00). Results Patient age (median) was 67.5 (range 50-80) years old, body mass index (median) was 22.5 (range 17.4-28.7) kg/m2, and serum PSA (median) was 7.5 (range 4.0- 31.9) ng/ml at the time of diagnosis. Clinical stage T1c was accounted for 7 cases, T2a was 9 cases, T2b was 3 cases, T2c was 11 cases, and T3a was 2 cases. Fourteen patients (43.8%) underwent nerve-sparing RALP. IIEF5 and sexual function domain of EPIC showed deterioration at 1 month after RALP. However, sexual bother domain of EPIC showed not significant difference after RALP. The relevance between change of sexual function and nerve-sparing operation were not observed at our observation period. On the other hand, daily use numbers of urinary pad were significantly improved as time passed compared with that of at 1 month after RALP. The relevance between urinary continence and nerve-sparing operation were observed at 1 month after RALP. Conclusions Sexual dysfunction after RALP showed the same change as that after LRP. Besides, nerve-sparing operation might affect for urinary continence instead of sexual function. Disclosure Work supported by industry: no.

Acceptance and Commitment Therapy to Increase Compliance to Intracavernosal Injection Use (ICI) Following Radical Prostatectomy (RP): Preliminary Results from a Randomized Control Trial

ABSTRACT Introduction ICI is the cornerstone of many erectile rehabilitation programs (ERP). However, compliance with ICI is historically low. Objective This study tests a novel psychological intervention based on Acceptance and Commitment Therapy (ACT) concepts to help men reduce avoidance to ICI and commit to an ERP. Methods This ongoing study recruits men starting in our ERP. The recruitment goal is N=220. Subjects are randomized to ERP+ACT or ERP+Enhanced Monitoring and Education (EME). ERP+ACT receive ERP plus 3 ACT Sessions (30-45min) and 10 ACT Booster Sessions (10min). ERP+EME receive ERP plus 3 EME Sessions (30-45min) and 10 EME Booster Sessions (10min) delivered by a nurse practitioner who monitors ICI use, answers questions, and provides education. The interventions are delivered over a year. Eligibility includes: within 9m post RP; functional pre-RP erections (≥6/10). Subjects are assessed at entry and every 6m for two years. The primary outcomes are number of penile injections/week (verified by syringe count), and compliance (defined as ≥2 injections/week). Secondary outcomes are: ED treatment satisfaction, sexual self-esteem and relationship quality, sexual bother, prostate cancer treatment regret, the psychological impact of cancer, and depressive symptoms. Preliminary 6m data is presented. Groups are compared with ANCOVA. Since these are preliminary analyses, if differences were not statistically significant, effect sizes (d) are reported (d=0.2, small effect; d=0.5, medium effect; d=0.8, large effect). Results To date, 120 subjects have been randomized; 62 have completed the 6m assessment (ACT n=33, EME n=29). The mean age was 60±7 years and 81% were married. The mean erectile function grade pre-RP was 8.9±1 (0-10 scale). At 6m, the ACT group utilized more injections/week vs. the EM group (median: 2.06 vs. 1.17, p=0.01) and were more compliant with ICI vs. the EM group (70% vs. 45%, p=0.05, RR=1.55). The ACT group reported greater: satisfaction with ED treatment (d=0.6) and overall sexual relationship (d=0.2). The ACT group also reported lower: sexual bother (d=0.2), prostate cancer treatment regret (d=0.3), negative psychological impact of cancer (d=0.3), and depressive symptoms (d=0.2). Conclusions Preliminary analysis suggests ACT significantly increases ICI use. Data also indicate ACT helps increase men's satisfaction with injections and sexual relationship, while reducing sexual bother, prostate cancer treatment regret, the psychological impact of cancer, and depressive symptoms. Disclosure No