Efficacy of a Novel Penile Traction Device in Improving Penile Length and Erectile Function Post Prostatectomy: Results from a Single-Center Randomized, Controlled Trial

Open AccessJournal of UrologyAdult Urology1 Aug 2021Efficacy a Novel Penile Traction Device in Improving Length and Erectile Function Post Prostatectomy: Results from Single-Center Randomized, Controlled TrialThis article is commented on by the following:Editorial CommentEditorial Comment Amir Toussi, Matthew Ziegelmann, David Yang, Madeleine Manka, Igor Frank, Stephen A. Boorjian, Tollefson, Tobias Köhler, Landon Trost ToussiAmir Toussi University Pittsburgh Medical Center, Pittsburgh, Pennsylvania More articles this author , ZiegelmannMatthew Ziegelmann Mayo Clinic, Rochester, Minnesota Financial and/or other relationship with Paradigm Communications. YangDavid Yang Johnson & Johnson. MankaMadeleine Manka FrankIgor Frank BoorjianStephen Boorjian Ferring, FerGene ArTara. TollefsonMatthew Tollefson KöhlerTobias Köhler TrostLandon §Correspondence: 1443 W. 800 N., Suite 202, Orem, Utah 84057 telephone: 801-655-0015; FAX: 801-655-0048; E-mail Address: [email protected] Male Fertility Peyronie’s View All Author Informationhttps://doi.org/10.1097/JU.0000000000001792AboutAbstractPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail Abstract Purpose: RestoreX novel penile traction therapy device, randomized, controlled data demonstrating improvements length erectile function after 30 90 minutes daily use men disease. We sought determine if similar could be achieved post prostatectomy. Materials Methods: Men prostatectomy were randomly assigned control or one 2 protocols for 6 months, followed 3-month open-label phase. The current study presents randomized primary outcome was changes stretched length; secondary outcomes International Index (IIEF) scores, adverse events, satisfaction subjective measures. Results: In all, 82 (mean age 58.6 years) 6-month available 25 controls cases. At greater improvements/preservation (+1.6 vs +0.3 cm, p <0.01), (IIEF-Erectile +0 ?6.5, p=0.03), intercourse (IIEF-Intercourse Satisfaction +1 ?3.5, <0.01) overall sexual (IIEF-Overall Sexual 0 ?3, <0.01). Erectogenic lower (phosphodiesterase-5 inhibitors 86% 94%, p=0.44; intracavernosal injections 19% 50%, <0.05). reported improvement than controls. Adverse events transient mild; 87% would choose repeat therapy, 93% recommend it others. Conclusions: device results significant objective measures function, satisfaction. External validation warranted. Abbreviations Acronyms AE event ED dysfunction EFD domain ICI injection IIEF PD disease PDE5 phosphodiesterase-5 inhibitor PTT RCT trial SEP encounter profile VED vacuum erection devices treatment prostate cancer several notable impacts male including reductions perceived actual length, dysfunction, ejaculatory/orgasmic increased incidence disease, among others.1–5 introduction nerve-sparing techniques radical has significantly improved outcomes, yet remains common bothersome contemporary series.6 Several investigators have evaluated various therapies “penile rehabilitation” improve function. goals rehabilitation traditionally been improve/preserve morphology postoperatively prevent fibrosis.7 Treatment commonly include inhibitors, devices. Despite multiple attempts, all high-level trials date failures any preserve/improve spontaneous function.8–10 Similarly, recent evaluating specific protocol closed early due poor accrual demonstrated no benefits PDE5s improving (NCT 00955929; limited available).11 Beyond VEDs, represents another form mechanical which used correct curvature increase length. its frequent PD, studies efficacy preserving/increasing One key limitation precluded widespread adoption traditional requirement 9 hours achieve benefits. Recently, (PathRight Medical, Plymouth, Minnesota) developed as second generation clamp mechanism, force delivered ability dynamically traction. Possibly these changes, shown use.12 also showed statistically clinically treated compared Given comorbidities associated prostatectomy, we investigate Specifically, hypothesized that result untreated Additionally, differences using different protocols. Material Methods Study Protocol Design Following institutional review board approval (IRB No. 18-001013), (NCT03500419) conducted phases evaluate (fig. 1). first phase involved randomizing 1:1:1 1) (Control), 2) minutes/day × 5 days/week (PTT A—low dose), 3) minutes, times/day 7 B—high dose). Funding provided internal funds, donated PathRight Medical. Figure 1. Overview protocol. Note reports assessment. Treatments performed straight only (ie counter-bending) dynamic adjustments assure ongoing per manufacturer recommendations. initiated 1-month continued months. Patients then entered an open label where they begin, continue stop additional 3 A power analysis detect 1 cm difference at months 80% (standard deviation 1.1 based prior data).12 indicated need 41 patients data, decision made enroll 20 each arm completion rates previously cited RCT. An interim higher number missing points anticipated, enrolled minimum data. Randomization To equal distributions differing lengths, randomization tables created priori baseline lengths <10, 10–13, 13.1–16, >16 cm. Inclusion criteria >18 years undergoing cancer. Exclusion who experienced urethral complications such anastomotic dehiscence. underwent surgery Clinic. Primary Secondary Outcomes variable change between (combined grouping). included (combined) subdomain AEs, Encounter Profile questions therapies. Other patient tolerability PTT, compliance groups B). combined grouping defined provide sufficient preliminary RCTs minimal groupings. However, subgroups designed into intent informing future studies, “signals” suggesting potential differences, population. not specifically counseled postprostatectomy therapies; however, permitted treatments desired. Data captured before compare utilization. limit confounders. highly surgeons goal performing bilateral nerve preservation appropriate. Outcome Measures Baseline assessments within month (measured pubic symphysis corona tip), demographic characteristics, standardized nonstandardized questionnaires, ED, curvature, assessments, IIEF. measured assessors blinded grouping. Assessments additionally (SEP-2, SEP-3), global assessment therapy. recorded location, symptom time resolution. completed diaries track use. Statistics analyzed intent-to-treat protocol, outliers excluded replaced optimize integrity. Statistical analyses JMP 14.2.0 (SAS Institute, Minneapolis, Minnesota). Normally distributed means standard deviations, while nonnormally skewed medians interquartile ranges. ANCOVA when variables both (eg IIEF). statistical tests Student’s t-test, Wilcoxon Rank Sum, chi-squared depending type. Two-tailed values <0.05 considered significant. total April 2018 through February 2020, controls, 18 A, 12 B. Mean weekly utilization (over weeks) 90.1 148.0 B, respectively. demographics are table demonstrate similarities clinical pathological variables, exception preoperative antigen, slightly (7.7 5.1, obtained median 8 days (IQR 7, 13), answer questionnaires Table Patient demographics, clinicopathological surgical Combined Control Value Demographics pts* 55 27 (SD) 58.7 (6.8) 58.2 (4.5) 0.66 Median (IQR): 26.5 (9, 30) 28 (14, 0.36 Orgasmic 10 (4.8, 10) (8, 0.19 desire (5, 9) (6, 0.10 Intercourse (0, 13) 11 0.18 Overall (5.8, 0.45 categorization (%):† 0.53 None (55.6) 15 Mild (13.0) 4 (14.8) Moderate (3.7) (11.1) Severe (27.8) (18.5) Self-reported ED: (%) 21 (38.2) (37.0) 0.92 mos duration (IQR) 24 (12, 66) 32 (24, 84) 0.57 past yr (20.0) (33.3) (0) 0.13 self-reported preop (16.3)‡ (19.2)§ 0.76 loss (14.8)† (15.4)§ 0.95 estimated amount (0.6, 2.4) 1.4) body mass index 29.7 29.3 (3.9) 0.71 race (%): 0.47 White 48 (87) (93) Black (7) (4) American Indian/Alaskan Native (2) Other/unknown Surgical Pathological PSA 7.7 (5.5, 10.7) 5.1 (4, 8.1) <0.01 perineural invasion biopsy (16.4) (22.2) 0.55 robotic approach (100) 26 (96.3) Gleason score 0.41 3+3 (7.3) 3+4 (58.2) 17 (63.0) 4+3 (3.6) 4+4 4+5 (1.8) 5+4 (7.4) 5+5 stage 0.27 T2 43 (78.2) (88.9) T3a (14.6) T3b node status 0.21 Nx (18.1) (29.6) N0 42 (76.3) 19 (70.4) N1 (5.5) metastatic pos 0.20 margin (20.4)† 1.00 sparing 0.51 Unilat (9.1) Bilat 49 (89.1) 23 (85.2) ADT (4.0)? radiation (2.0) 0.35 biochemical recurrence last followup (12.0)? 0.52 utilized continuous, distribution, T-tests normally Fisher’s Exact Likelihood ratio categorical variables. Bolded item signifies significance. Number participants unless otherwise indicated. †In 54 patients. ‡In 50 corona. Findings measurements tip +0.7 p=0.01). Percent ranged 10.6% 14.3% 3.5% 5.0% (p <0.001 0.03). Subjective favor 56% 13% reporting <0.001), 0% <0.0001). preserved/improved (IIEF-EFD) ?6.5 (p=0.03), achieving minimally (4 points).13 Indirect suggestive maintained/improved SEP-2 SEP-3 nonstatistically men, observed (p=0.44 PDE5s, ICI). Statistically noted domains (both orgasmic domains. hoc IIEF-EFD scores 84% groups, findings likely reliable. demonstrates subdomains PTT-treated men. 2. device. figure Values subtracting results; value refers comparison controlling (ANCOVA). high, respondents rating 8/10 (10=extremely satisfied). friend, utilize redo therapy; resulted meaningful overall. Key (post-randomization phase) Value* pts Objective Change cm: tip, mean 1.6 (1.0) 0.7 (1.5) 0.01 % 10.6 (7.1) 5.0 (9.7) 0.03 corona, 0.3 14.3 3.5 (10.1) (%)/Total (86)/21 (94)/16 0.44 (19)/21 (50)/16 Standardized Questionnaires IIEF:† 29 (IQR):‡ (all-comers) (?7.5, 4) (?21.5, ?2) (baseline ?25) +5 14.5) ?6 (?14.5, ?0.5) 0.28 ?2 (?5, 0) ?4 (?7, 0.84 (?1, 1.5) ?1 (?2, 0.5) 0.85 7) ?3.5 (?2.8, 0.8) ?3 (?6, ?1) (77)/26 13 (65)/20 (68)/25 (53)/19 Additional Responses No.: Very satisfied (30)/27 (0)/23 Somewhat (26)/27 (13)/23 Neutral (33)/27 (43)/23 dissatisfied (11)/27 (26)/23 0/27 (17)/23 <0.0001 Yes (56)/27 (0)/16 No (81)/16 Worse (4)/27 (6)/16 Unsure (13)/16 Estimated (IQR)/Total 17.5 (10, 26.3)/18 NA Large (16.7)/18 Medium (55.6)/18 Small (27.8)/18 “How does your FLACCID surgery?” Much shorter (0)/27 (23.5)/17 Slightly (22.2)/27 (35.3)/17 Same 14 (51.9)/27 (41.2)/17 longer (25.9)/27 (0)/17 ERECT 0.39 (4.6)/14/22 (21.4)/14 (22.7)/14/22 (28.6)/14 (40.9)/14/22 (31.8)/14/22 (0)/14/22 (0)/14 “Has improvement?” (84.0)/25 (16.0)/25 1–10 scale No.§ (7, 9)/29 comfort No.? 8)29 friend Recommend (93)/30 Indifferent (7)/30 Discourage (0)/30 (87)/30 (13)/30 NA=not applicable. significance IIEF, continuous single cells <5. items signify values. contrast, Negative denotes Where 10=extremely satisfied. 10=most comfortable. separate B; 3). regarding domains, B (longer protocol). 3. subgroup (postrandomization (30 min/day, days/wk) (60 Groups* (SD)/Total (1.5)/25 1.7 (1.0)/16 1.3 (0.9)/10 0.46 (1.1)/16 (0.8)/10 0.83 No.:†,‡ ?2)/24 ?0.5 (?10.8, 3.5)/18 ?5)/11 0.26 0)/24 ?5 0)/18 (?2.5, 0.8)/11 0.5)/24 1.3)/18 2)/11 0.11 0.5 (?4, 4)/18 8)/11 ?1)/24 (?3, 1)/11 0.30 (65.0)/20 (81.3)/16 (70.0)/10 (52.6)/19 (62.5)/16 (77.8)/9 0.42 (93.8)/16 (83.3)/12 (88.9)/9 0.72 (50.0)/16 (25.0)/12 1(11.1)/9 published series mild, erythema, discomfort sensory 20.0%, 36.7%, 10.1% respectively (table 4).12,14 symptoms >24 hours, subsequent resolution over following days, others resolved discontinuing treatment. group de novo consistent none (p=0.32). 4. Controls Total Temporary erythema discoloration mild (36.7) sensation Any (46.8) Medium-term (>24 hrs) (3.3) Long-term (persistent later) De indentation (3.3)* 0* p=0.32 comparing Discussion setting. relevant These important, represent preserve (described detail below). There protocols, may effectively about 90–150 weekly). well tolerated dropouts AEs. decades. Since nerve-preserving there successfully placebo-controlled settings.6 Two vardenafil tadalafil (penile rehabilitation) failed drug washout.8,9 ICI, intraurethral suppositories topical Among devices, pilot either control.10 men; VED, presented erections without concomitant VED. above our knowledge, medications immediately preceding intercourse. 6.5 points, accepted threshold indicate difference.13 further supported decreased (nonstatistically significant) (significant), (nonsignificant), (significant) If validated external series, advancement management prevention dysfunction. Improvements PD.12,14 As study, supporting evidence impact Although exact mechanism unknown, explanations tensile-force mediated release nitric oxide upregulation synthase, animal models human vascular diminished fibrosis preserved length) leading venous leak.15–17 report increases increase. ranging 1.3–2.3 cohorts.12,14,18 This contrasts RCT, baseline.10 Interestingly, found (+0.3 cm) despite 59% losses, reports.19 limitations, single-center design lack viable sham. lead inventor conducted. dropout introduce bias (33% data). challenges contributed travel restrictions COVID-19, interstate/international nature practice, planned return date, incentive already received device), It important recognize 59 years, should taken account extrapolating populations. strengths, design, establishment instruments, inclusion (no exclusions), adequate power, duplicate. Conclusions 60 5–7 week high tolerance Pending validation, requiring on-demand Acknowledgments authors wish acknowledge generous gift patient, wishes remain anonymous, facilitated research. work contributions Kelly Paulson, Leanne Sandieson, Dawn Schaber-Goa, Alex Ferguson, Tessa Kroeninger Brett Milazzo (study coordinators) Leah Verderame, Elyse Mueller Bandilli (men’s health nurses). References : Peyronie's prostatectomy: predictors. J Sex Med 2010; 7: 1254. Google Scholar Survival localized cancer: international collaborative review. Eur Urol 2018; 73: 11. Changes morphometrics retropubic Mol 1999; 3: 109. Pilot Urology 2001; 58: 567. 5. prospective measuring 2003; 169: 1462. Link, 6. Radical function: anatomical considerations. Prostate 1983; 4: 473. 7. Histological alterations cavernous tissue 2005; 173: 1673. 8. Effect nightly versus recovery 2008; 54: 924. 9. Effects randomised (REACTT). 2014; 65: 587. 10. BJU Int 2007; 100: 858. controlled, 3-arm pharmacological 2021; 18: 423. 12. peyronie's disease: single-blind, trial. 2019; 202: 599. 13. Minimal scale. 2011; 60: 1010. 14. follow-up phases. 2020; 17: 2462. 15. Acute stretch promotes eNOS activation endothelial mainly via PKA Akt pathways. PLoS 2013; 8: e71359. 16. wall shear stress flow-mediated dilation: assessed phase-contrast magnetic resonance angiography. Am Coll Cardiol 38: 1859. 17. hemodynamic profiles their correlation 2002; 167: 1371. 18. Efficacy collagenase Clostridium histolyticum 16: 891. 19. Prospective 113: E131. Supported Clinic LT royalty sharing agreements established funding charge. access under terms Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND), permits downloading properly cited. cannot changed way commercially permission journal.© 2021 Author(s). Published behalf Urological Association, Education Research, Inc.FiguresReferencesRelatedDetailsCited BySmith (2021) Month Adult UrologyJournal Urology, VOL. 206, NO. 2, (187-189), Online publication date: 1-Aug-2021.Related articlesJournal UrologyJun 1, 2021, 12:00:00 AMEditorial CommentJournal Volume 206Issue 2August 2021Page: 416-426 Advertisement Copyright Permissions© Inc.Keywordserectile dysfunctionpenile indurationtractionrehabilitationprostatectomyAcknowledgmentsThe nurses).MetricsAuthor Information Expand Loading ...