Dataset Information

The controversy surrounding penile rehabilitation after radical prostatectomy.

ABSTRACT: Radical prostatectomy (RP) techniques have been refined in the last few decades. Despite nerve-sparing surgery, erectile dysfunction (ED) still seems to be affecting more than half of patients undergoing RP. Penile rehabilitation consists of understanding the mechanisms that affect erectile function (EF) and utilizing pharmacologic agents, devices or interventions to promote male sexual function before and after any insult to the penile erectile physiologic axis. There currently is a limited amount of clinical trials that assess treatments with the goal of recovering post-prostatectomy EF. The goal of this article is to assess a contemporary series of trials that study penile rehabilitation. Although the current evidence lacks to prove its irrefutable effectiveness, advancements in research and technology forecast a promising future in penile rehabilitation management.

SUBMITTER: Clavell-Hernandez J

PROVIDER: S-EPMC5313301 | biostudies-other | 2017 Feb

REPOSITORIES: biostudies-other

ACCESS DATA

Publications

The controversy surrounding penile rehabilitation after radical prostatectomy.

Clavell-Hernández Jonathan J Wang Run R

Translational andrology and urology 20170201 1

Radical prostatectomy (RP) techniques have been refined in the last few decades. Despite nerve-sparing surgery, erectile dysfunction (ED) still seems to be affecting more than half of patients undergoing RP. Penile rehabilitation consists of understanding the mechanisms that affect erectile function (EF) and utilizing pharmacologic agents, devices or interventions to promote male sexual function before and after any insult to the penile erectile physiologic axis. There currently is a limited amo ...[more]

PMID: 28217445

Similar Datasets

Project description:BackgroundAlthough the concept of penile rehabilitation after radical prostatectomy (RP) has been advocated for decades, there is little definitive evidence regarding its utility or the best strategy to optimize patient outcomes.AimThe goal of this study is to analyze the ability of 3 different pharmacological strategies to preserve the ability of men to achieve spontaneous (non-medication assisted) erections after bilateral nerve-sparing RP.MethodsThis IRB- and FDA-approved study studied penile rehabilitation in a 3-arm fashion with a target enrollment of 200 patients. (i) Control arm: nightly placebo with sildenafil 100 mg on demand for sexual relations (up to 6 pills/month); (ii) nightly sildenafil arm: nightly sildenafil 50 mg and sildenafil 100 mg on demand for sexual relations (up to 6 pills/month); (iii) combination therapy arm: nightly sildenafil 50 mg (5 nights/week) plus intracavernosal injections twice/week. Inclusion criteria included bilateral nerve-sparing surgery, normal serum total testosterone, and good preoperative baseline erectile function as measured by the erectile function domain score of the IIEF (EFD) (≥24). Patients were followed with a medication use diary and the IIEF questionnaire at 6 weeks, 3 m, 6 m, 12 m, 18 m and 24 m.OutcomesA difference was seen in the IIEF-EFD scores between the 3 groups at 24 months after RP. Secondary end points include the time to return of spontaneous functional erections, the time for patients to respond to oral erectogenic therapy, and the proportion of patients who have normalization of their IIEF-EFD scores.ResultsThe study was interrupted because of failure to recruit the target study population in a reasonable timeframe. A total of 76 subjects with median age of 57 (IQR: 51, 63) years and mean IIEF-EFD of 29 (IQR: 27, 30) were initially randomized, but at 24 months, the sample sizes by group were (i) n = 4; (ii) n = 18; and (iii) n = 10, with median IIEF-EFD 24 (IQR: 18, 28), 24 (IQR: 18, 28), and 21 (IQR: 9, 26), respectively. There was no statistical difference among the groups in the final analysis.Clinical implicationsDefinitive evidence for the ability of different pharmacological rehabilitation strategies to improve long-term EF outcomes might never be available.Strengths & limitationsThis was a well-designed randomized and 3-arm designed trial intended to provide decisive evidence regarding the utility of penile rehabilitation. Failure to recruit the target population is the main limitation.ConclusionThe limited number of patients in the present trial precludes definitive interpretation. However, results indicate how challenging it is to conduct true rehabilitation studies. Miranda EP, Benfante N, Kunzel B, et al. A Randomized, Controlled, 3-Arm Trial of Pharmacological Penile Rehabilitation in the Preservation of Erectile Function After Radical Prostatectomy. J Sex Med 2021;18:423-429.

Project description:IntroductionDespite the importance of using penile injections as part of a penile rehabilitation program, men have difficulty complying with these programs.AimTo test a novel psychological intervention based on Acceptance and Commitment Therapy for erectile dysfunction (ACT-ED) to help men utilize penile injections.MethodsThis pilot randomized controlled trial (RCT) recruited men who were beginning a standard care (SC) structured penile rehabilitation program following radical prostatectomy. The SC program instructed patients to use penile injections 2 to 3 times per week. Participants were randomized to SC+ACT-ED or SC+enhanced monitoring (EM). Over 4 months, patients in the SC+ACT-ED group received SC plus 4 ACT sessions and 3 ACT phone calls; those in the EM group received SC plus 7 phone calls from an experienced sexual medicine nurse practitioner. Participants were assessed at study entry and at 4 and 8 months. For this pilot study, the goal was to determine initial efficacy (ie, effect sizes, where d = 0.2 is small, d = 0.5 is medium, and d = 0.8 is large).Main outcome measurePrimary outcomes were feasibility and use of penile injections. Secondary outcomes were ED treatment satisfaction (ie, Erectile Dysfunction Inventory of Treatment Satisfaction, or EDITS), sexual Self-Esteem and Relationship (SEAR) quality, sexual bother (SB), and prostate cancer treatment regret.ResultsThe 53 participants were randomized (ACT, n = 26; EM, n = 27). The study acceptance rate was 61%. At 4 months, the ACT-ED group utilized more penile injections per week (1.7) compared to the EM group (0.9) (d = 1.25; P = .001) and was more adherent to penile rehabilitation compared to the EM group (ACT, 44%; EM, 10%; relative risk [RR], 4.4; P = .02). These gains were maintained at 8 months for injections per week (ACT, 1.2; EM, 0.7; d = 1.08; P = .03) and approached significance for adherence (ACT, 18%; EM, 0%; P = .10). At 4 months, ACT-ED, compared to EM, reported moderate effects for greater satisfaction with ED treatment (d = 0.41; P = .22), greater sexual self-esteem (d = 0.54; P = .07) and sexual confidence (d = 0.48; P = .07), lower sexual bother (d = 0.43; P = .17), and lower prostate cancer treatment regret (d = 0.74; P = .02). At 8 months, moderate effects in favor of ACT-ED were maintained for greater sexual self-esteem (d = 0.40; P = .19) and less treatment regret (d = 0.47; P = .16).Clinical implicationsACT concepts may help men utilize penile injections and cope with the effects of ED.Strengths and limitationsStrengths include use of an innovative intervention utilizing ACT concepts and pilot RCT. Limitations include the pilot nature of the study (eg, small samples size, lack of statistical power).ConclusionACT-ED is feasible and significantly increases the use of penile injections. ACT-ED also shows promise (moderate effects) for increasing satisfaction with penile injections and sexual self-esteem while decreasing sexual bother and prostate cancer treatment regret. Nelson CJ, Saracino RM, Napolitano S, et al. Acceptance and Commitment Therapy to Increase Adherence to Penile Injection Therapy-Based Rehabilitation After Radical Prostatectomy: Pilot Randomized Controlled Trial. J Sex Med 2019; 19:1398-1408.

Project description:BackgroundPenile prosthesis surgery (PPS) is a commonly used treatment for erectile dysfunction (ED), either as first-line therapy or in cases refractory to other treatment options. In patients with a urologic malignancy such as prostate cancer, surgical interventions like radical prostatectomy (RP) as well as non-surgical treatments such as radiation therapy can all induce ED. PPS as a treatment for ED has high satisfaction rates in the general population. Our aim was to compare sexual satisfaction in patients with prosthesis implantation for ED following RP versus ED following radiation therapy for prostate cancer.MethodsA retrospective chart review from our institutional database was conducted to identify patients who underwent PPS at our institution from 2011 to 2021. Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire data at least 6 months from implant operative date available was required for inclusion. Eligible patients were placed in one of two groups depending on etiology of ED-following RP or prostate cancer radiation therapy. To prevent crossover confounding; patients with history of pelvic radiation were excluded from the RP group and patients with history of RP were excluded from the radiation group. Data were obtained from 51 patients in the RP group and 32 patients in the radiation therapy group. Mean EDITS scores and additional survey questions were compared between the radiation and RP groups.ResultsThere was a significant difference in mean survey responses for 8 of the 11 questions in the EDITS questionnaire between the RP group and the radiation group. Additional survey questions administered also found RP patients reported significantly higher rate of satisfaction with size of penis post-operatively versus the radiation group.ConclusionsThese preliminary findings, while requiring large-scale follow-up, suggest that there is greater sexual satisfaction and penile prosthesis device satisfaction in patients undergoing IPP placement following RP versus radiation therapy for prostate cancer. Use of validated questionnaires should continue to be utilized in quantifying device and sexual satisfaction following PPS.

Project description:BackgroundsConsidering the natural course of cavernous nerve recovery after robot-assisted laparoscopic prostatectomy (RALP), early intervention of low intensity extracorporeal shock wave therapy (LIESWT) would be more effective for enhancing overall recovery of sexual function (SF). Our objective of this study is to analyze longitudinally the alterations of SF in patients after RALP, with a focus on the effect of early and delayed intervention with LIESWT.MethodsA total of 5 and 11 patients underwent early and delayed intervention with LIESWT, respectively. SF was assessed with the Expanded Prostate Cancer Index Composite (EPIC). The same surgeon performed RALP on 178 patients, and these patients were assigned to the non-LIESWT group to establish a control group. The SF score of EPIC was investigated longitudinally before RALP and 3, 6, 9, and 12 months after RALP.ResultsOur results show that penile rehabilitation with LIESWT immediately before urethral catheter removal improved SF scores. In the baseline, the SF score was significantly higher in the early LIESWT group (P=0.0001). The SF score was significantly lower at postoperative 6 months (early 19.2, delayed 17.9, and non-LIESWT 8.1; P=0.0171), 9 months (20.9, 25.8, and 10.2; P=0.0188), and 12 months (28.0, 21.3, and 9.5; P=0.0051) in the non-LIESWT group. We regret that there was no significant difference in the recovery of SF between the early and delayed protocol with LIESWT at all points. In keeping with our results, LIESWT demonstrated the potential to be efficacious in treatment options for severe post-radical prostatectomy (RP) erectile dysfunction (ED) as it may indirectly support its promotion of nerve regeneration in severe ED due to RP.ConclusionsThis is the first study in which LIESWT has been shown to deliver a clinical benefit on its early or delayed intervention to patients after RALP to penile rehabilitation in terms of restoring SF. Our preliminary results suggest that LIESWT could be used as a treatment option in penile rehabilitation.

Project description:ObjectiveTo examine the effect of penile vibratory stimulation (PVS) in the preservation and restoration of erectile function and urinary continence in conjunction with nerve-sparing radical prostatectomy (RP).Patients and methodsThe present study was conducted between July 2010 and March 2013 as a randomized prospective trial at two university hospitals. Eligible participants were continent men with an International Index of Erectile Function-5 (IIEF-5) score of at least 18, scheduled to undergo nerve-sparing RP. Patients were randomized to a PVS group or a control group. Patients in the PVS group were instructed in using a PVS device (FERTI CARE(®) vibrator). Stimulation was performed at the frenulum once daily by the patients in their own homes for at least 1 week before surgery. After catheter removal, daily PVS was re-initiated for a period of 6 weeks. Participants were evaluated at 3, 6 and 12 months after surgery with the IIEF-5 questionnaire and questions regarding urinary bother. Patients using up to one pad daily for security reasons only were considered continent. The study was registered at http://clinicaltrials.gov/ (NCT01067261).ResultsData from 68 patients were available for analyses (30 patients randomized to PVS and 38 patients randomized to the control group). The IIEF-5 score was highest in the PVS group at all time points after surgery with a median score of 18 vs 7.5 in the control group at 12 months (P = 0.09), but the difference only reached borderline significance. At 12 months, 16/30 (53%) patients in the PVS group had reached an IIEF-5 score of at least 18, while this was the case for 12/38 (32%) patients in the control group (P = 0.07). There were no significant differences in the proportions of continent patients between groups at 3, 6 or 12 months. At 12 months 90% of the PVS patients were continent, while 94.7% of the control patients were continent (P = 0.46).ConclusionThe present study did not document a significant effect of PVS. However, the method proved to be acceptable for most patients and there was a trend towards better erectile function with PVS. More studies are needed to explore this possible effect further.

Dataset Information

The controversy surrounding penile rehabilitation after radical prostatectomy.

Publications

The controversy surrounding penile rehabilitation after radical prostatectomy.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets