Urinary Quality Of Life Research Articles

Low-dose-rate brachytherapy for prostate cancer: outcomes at >10 years of follow-up.

To examine biochemical control, survival, and late morbidity with definitive low-dose-rate brachytherapy (LDR-BT) for patients with prostate cancer surviving for >10 years after treatment. We identified 757 men with localised prostate cancer who underwent definitive LDR-BT in the period 1990-2006 and were followed for >10 years at our institution. Biochemical failure-free survival (BFFS), distant metastases-free survival (DMFS), prostate cancer-specific survival (PCSS), and overall survival (OS) were selected as study endpoints. Survival was examined using the log-rank test, Kaplan-Meier method, and Cox regression modelling. Urinary, quality of life (QoL), and potency scores at baseline and last follow-up were recorded. The median follow-up was 12.5 years (range, 10.1-21.8 years). At the time of analysis, 88.6% of patients were alive, 1.5% died from prostate cancer and 13.9% developed biochemical failure, with 82% of failures occurring in the first decade of follow-up. Overall, 2.3% developed distant metastases. On multivariate analyses, stage T3a-T3b, prostate-specific antigen level of >20 ng/mL, intermediate- and high-risk disease predicted worse BFFS; whereas age >70 years at diagnosis and stage T3a-T3b predicted worse OS. A total biologically effective dose of ≥150 Gy and androgen-deprivation therapy were associated with improved BFFS, but not OS. The overall 17-year rates for BFFS, DMFS, PCSS, and OS were 79, 97, 97, and 72%, respectively. Respective 17-year BFFS rates for low-, intermediate- and high-risk patients were 86, 80, and 65% (P < 0.001), whereas OS rates for the same groups were 82, 73, and 60%, respectively (P = 0.09). Amongst those patients who were potent at baseline, 25% remained potent at the last follow-up. Urinary function and QoL were mainly unaffected. LDR-BT yields excellent survival rates, with a 17-year PCSS rate of 97%. In all, 18% of patients with biochemical relapse failed at >10 years after implantation, which justifies their continued follow-up.

Robotic-assisted Sacrocolpopexy with versus without Concomitant Midurethral Sling: A 2-year Follow-up of Urinary Symptoms and Quality of Life.

Objective:The objective of this study was to assess long-term postoperative urinary incontinence (UI) symptoms and quality of life (QOL) in patients after robotic-assisted sacrocolpopexy (RASC) with or without concomitant midurethral sling (MUS).Materials and Methods:This is a cross-sectional survey of patients comparing long-term postoperative urinary symptoms and QOL measurements in women who underwent RASC with or without MUS. We included all patients from 2011 to 2014 who had RASC with or without MUS. All patients had preoperative urodynamic testing (UDS). Patients who demonstrated stress UI on UDS underwent MUS at the time of RASC. Urinary symptoms and QOL were assessed through the validated Urinary Distress Inventory-6 (UDI-6) and Incontinence Impact Questionnaire-7 (IIQ-7) patient questionnaires.Results:Sixty-eight patients met inclusion criteria, 46 patients completed follow-up questionnaires, and were included in the final analysis. Average length of time to follow-up from surgery was 24 months (range: 6–36 months). A statistically significant difference in UDI-6 scores between the two groups (RASC vs. RASC + MUS) was observed. Median (25th and 75th percentiles) scores for UDI-6 were 22.92 (8.33 and 32.29, respectively) for the RASC group and 4.17 (0 and 13.54, respectively) for the RASC + MUS group (P = 0.0017). Median scores for IIQ-7 were 0 (0 and 29.73 for the 25th and 75th percentiles, respectively) for the RASC group and 0 (0 and 0, respectively) for the RASC + MUS group (P = 0.1691).Conclusion:Patients who underwent RASC + MUS scored significantly lower on the UDI-6, indicating fewer urinary distress symptoms. Although not statistically significant, patients in the RASC + MUS group had lower IIQ-7 scores, indicating less negative impact on QOL, compared to the RASC-only group.

Absorbable Hydrogel Spacer Use in Prostate Radiotherapy: A Comprehensive Review of Phase 3 Clinical Trial Published Data

To provide an update on SpaceOAR System, a Food and Drug Administration-approved hydrogel indicated to create distance between the prostate and the rectum which has been studied in phase 2 and 3 clinical trials. Here, we review and summarize these clinical results including the safety of prostate-rectum spacer application technique, the implant quality and resulting rectal dose reduction, acute and long-term rectal, urinary, and sexual toxicity, as well as patient-reported outcomes. A prospective, randomized patient-blinded clinical study was performed comparing image-guided intensity modulated prostate radiotherapy (79.2 Gy in 44 fractions) in men with or without prostate-rectum hydrogel spacer. Patients were followed up for 3 years, allowing assessment of long-term safety and efficacy. Spacer application was well tolerated with a 99% technical success rate. The mean additional space created between the prostate and the rectum was just over 1 cm, which allowed significant rectum and penile bulb radiation dose reduction, resulting in less acute pain, lower rates of late rectal toxicity, and improved bowel and urinary quality of life (QOL) scores from 6 months onward. Improvements in sexual QOL were also observed at 37 months in baseline-potent men, with 37.5% of control and 66.7% of spacer men capable of "erections sufficient for intercourse." Prostate-rectum hydrogel spacer application is a relatively safe technical procedure that is well tolerated and has a high technical success rate. Spacer application significantly reduces rectal radiation dose and results in long-term reductions in rectal toxicity, as well as improvements in bowel, urinary, and sexual QOL.

Laparoscopic and robot-assisted vs open radical prostatectomy for the treatment of localized prostate cancer: a Cochrane systematic review.

To determine the effects of laparoscopic radical prostatectomy (LRP), or robot-assisted radical prostatectomy (RARP) compared with open radical prostatectomy (ORP) in men with localized prostate cancer. We performed a comprehensive search using multiple databases (CENTRAL, MEDLINE, EMBASE) and abstract proceedings, with no restrictions on the language of publication or publication status, up until 9 June 2017. We included all randomized or pseudo-randomized controlled trials that directly compared LRP and RARP with ORP. Two review authors independently examined full-text reports, identified relevant studies, assessed the eligibility of studies for inclusion, extracted data and assessed risk of bias. We performed statistical analyses using a random-effects model and assessed the quality of the evidence according to Grading of Recommendations Assessment, Development and Evaluation (GRADE). The primary outcomes were prostate cancer-specific survival, urinary quality of life and sexual quality of life. Secondary outcomes were biochemical recurrence-free survival, overall survival, overall surgical complications, serious postoperative surgical complications, postoperative pain, hospital stay and blood transfusions. We included two unique studies in a total of 446 randomized participants with clinically localized prostate cancer. All available outcome data were short-term (up to 3 months). We found no study that addressed the outcome of prostate cancer-specific survival. Based on one trial, RARP probably results in little to no difference in urinary quality of life (mean difference [MD] -1.30, 95% confidence interval [CI] -4.65 to 2.05; moderate quality of evidence) and sexual quality of life (MD 3.90, 95% CI: -1.84 to 9.64; moderate quality of evidence). No study addressed the outcomes of biochemical recurrence-free survival or overall survival. Based on one trial, RARP may result in little to no difference in overall surgical complications (risk ratio [RR] 0.41, 95% CI: 0.16-1.04; low quality of evidence) or serious postoperative complications (RR 0.16, 95% CI: 0.02-1.32; low quality of evidence). Based on two studies, LRP or RARP may result in a small, possibly unimportant improvement in postoperative pain at 1 day (MD -1.05, 95% CI: -1.42 to -0.68; low quality of evidence) and up to 1 week (MD -0.78, 95% CI: -1.40 to -0.17; low quality of evidence). Based on one study, RARP probably results in little to no difference in postoperative pain at 12 weeks (MD 0.01, 95% CI: -0.32 to 0.34; moderate quality of evidence). Based on one study, RARP probably reduces the length of hospital stay (MD -1.72, 95% CI: -2.19 to -1.25; moderate quality of evidence). Based on two studies, LRP or RARP may reduce the frequency of blood transfusions (RR 0.24, 95% CI: 0.12-0.46; low quality of evidence). Assuming a baseline risk for a blood transfusion to be 8.9%, LRP or RARP would result in 68 fewer blood transfusions per 1,000 men (95% CI: 78-48 fewer). There is no evidence to inform the comparative effectiveness of LRP or RARP compared with ORP for oncological outcomes. Urinary and sexual quality of life appear similar. Overall and serious postoperative complication rates appear similar. The difference in postoperative pain may be minimal. Men undergoing LRP or RARP may have a shorter hospital stay and receive fewer blood transfusions.

Bowel and urinary quality of life after whole-pelvic versus prostate-only volumetric-modulated arc therapy for localized prostate cancer

PurposeThis study aimed to compare bowel and urinary health-related quality of life (HRQOL) between prostate-only (PO) volumetric modulated arc therapy (VMAT) and whole-pelvis (WP) VMAT in patients with localized prostate cancer. Methods and materialsA total of 234 patients treated with definitive VMAT to 78 Gy in 39 fractions were enrolled. Of these, 108 patients received PO-VMAT and 126 patients received initial WP-VMAT to 46.8 Gy in 26 fractions using a simultaneous integrated boost technique. HRQOL was prospectively assessed before radiation therapy (baseline), and 3, 6, 12, and 24 months after treatment using the Expanded Prostate Cancer Index Composite (EPIC). ResultsBaseline HRQOL scores did not differ significantly between the 2 groups. No significant between-group differences in HRQOL change from baseline were observed for all bowel and urinary EPIC domains. The proportion of patients showing a clinically relevant decrease in bowel and urinary HRQOL scores from baseline was similar between the groups throughout the follow-up period. An analysis of individual HRQOL items showed that patients undergoing WP-VMAT were more likely to report moderate/big problems with bloody stools (P = .039) and overall bowel problems (P = .008) than those undergoing PO-VMAT at 12 months. There was no significant between-group difference in any individual items at 24 months, however. ConclusionsBowel and urinary HRQOL is largely similar for patients receiving PO-VMAT and WP-VMAT during 24 months of follow-up, with the only differences seen in responses to specific bowel HRQOL items at 12 months.

Comparisons of health-related quality of life among surgery and radiotherapy for localized prostate cancer: a systematic review and meta-analysis.

The objective of this study is to compare health-related quality of life (QOL) outcomes between radical prostatectomy (RP) and external beam radiation therapy (EBRT) for localized prostate cancer. PubMed, EMBASE, the Cochrane Library and Web of Science (to July 2017) were searched. Pooled analysis of each domain-specific score was calculated in relevant studies, and its change with follow-up time was explored by sub-group analysis. A total of six studies containing 4423 patients were included. Men underwent RP was associated with worse urinary and sexual domain score than EBRT (standardized mean difference (SMD) = –0.59, –0.58; 95% confidence interval (CI) = –0.73 to –0.45, –0.72 to –0.44). In contrast, EBRT group had lower bowel domain score than RP group (SMD = 0.42, 95% CI = 0.33 to 0.52). The sub-group analysis revealed the most severe urinary and sexual QOL in RP as well as bowel QOL in EBRT group all happened in the first month post operation. The different performance of two treatments in three QOL domains diminished afterwards. Health-related QOL should be considered comprehensively when planning follow-up for men after RP or EBRT for localized prostate cancer.

Toxicity and Quality of Life (QoL) Comparison between Two Escalation Dose Fractionation Protocols With Steroatactic Body Radiation Therapy in Prostate Cancer

Dose escalation in prostate cancer showed an increase in toxicity in several normofractionation trials. The low alpha beta ratio of prostate cancer seems to make appropriate dose escalation with extreme hypofractionation. To compare toxicity and Quality of Life (QoL) of two regimens (SBRT alone 85 GyEqD2 or SBRT as a boost 87GyEqD2) of hypofractionated stereotactic body radiation therapy (SBRT) with intensity modulated arc therapy (IMAT). Two prospective phase I-II SBRT studies in prostate cancer, approved by our institutional review and ethics board were used. Hormonal-therapy was prescribed according to risk classification. Image Guided RT with Cone Beam CT was mandatory. Dose SBRT was delivered at a prescribed planning target volume (PTV) 35 Gy in five fractions in 5 alternative days (Trial 1)or 9 Gy after 60 Gy 2 Gy per fraction in 30 days (Trial 2), using with RapidArc IMAT, with 6 MV FFF photons. CTCAE v4.0 morbidity scores were used to assess toxicities. Health-related quality of life questionnaire, such as EPIC, was administered centrally by telephone interview before treatment and during follow-up (at 3, 6 and 12 months). Comparison of dosimetric parameters by t-student test, toxicities by Wilcoxon rank sum test and QoL values by confidence intervals were done between the two groups of patients. Forty patients have been recruited. Mean age was 70.2 years. Twenty-two patients were included in trial 1 and 18 in trial 2. According to D'Amico risk classification for trial 1), 3/22 patients were low-risk and 19/22 were intermediate risk, for trial 2) 18 patients were high risk. All patients completed the treatment as programmed with good tolerance. Median follow-up was 15 months (3-41). Prostate, urethral, bladder and rectal volumes are not statistically different between groups. No toxicity greater than grade 2 was observed. Acute GU and GI grade 2 toxicities were higher in trial 1 for week after treatment 40.9% vs 27.8 % and 36.4% vs 11.1%. At the 1st month GI Grade 2 toxicity was also higher for trial 1, 36.4% vs trial 2, 13.6%. No significant differences were found in GU or GI toxicities during follow-up between groups. EPIC urinary, EPIC incontinence and EPIC obstructive QoL values were significantly better at 6 and 12 moths for trial 1 vs trial 2. No differences were seen in EPIC bowel values. Considering a median follow-up period of 15 months, dose escalation to 85 (EqD2)Gy or to 87 (EqD2)Gy showed a different early toxicity profile, time factor with longer overall treatment time in the higher dose (trial 2) may modulate this fact. Low dose showed significantly better QoL urinary function. Longer follow-up is needed to validate these results.

Quality of Life in Patients Who Underwent Intensity-Modulated Radiation Therapy, 125 I Brachytherapy, and Combined 125 I Brachytherapy Plus Three-Dimensional Conformal Radiation Therapy for Prostate Cancer

To evaluate quality of life (QOL) in patients who underwent intensity-modulated radiation therapy (IMRT), I125 brachytherapy (BT), and BT combined with three-dimensional conformal radiation therapy (BT + 3D-CRT) for prostate cancer (PCa) patients. We conducted a prospective trial to evaluate health-related QOL for patients who underwent IMRT, BT, and BT + 3D-CRT. QOL was estimated by the Expanded Prostate Cancer Index Composite (EPIC) questionnaire before each treatment and at 1, 3, 6, 12, and 24 months. Multivariate analyses were conducted to determine factors associated with lowering urinary and bowel domain scores at 12 months from baseline. Data were analyzed from 555 (IMRT: n = 123, BT: n = 227, BT + 3D-CRT: n = 205) at 12 months. Mean change in the urinary summary score at 12 months was −0.01, −3.4, and −4.1 points among patients treated with IMRT, BT, and BT + 3D-CRT, respectively. Mean change in the bowel summary score at 12 months was −3.5, −1.1, and −2.8 points among patients treated with IMRT, BT, and BT + 3D-CRT, respectively.On multivariate analysis of factors that predict a lower EPIC score of the urinary domain at 12 months, BT (OR 1.91, 95% CI 1.11–3.28) and BT + 3D-CRT (OR 2.14, 95% CI 1.24–3.70) groups had lower urinary QOL at 12 months using the IMRT group as a reference. In addition, on multivariate analysis of factors that predict a lower EPIC score of the urinary domain at 24 months, BT (OR 1.82, 95% CI 1.04–3.20) and BT + 3D-CRT (OR 3.11, 95% CI 1.77–5.48) groups had lower urinary QOL using the IMRT group as a reference.On multivariate analysis of factors predicting a lower EPIC score in the bowel domain, the BT + 3D-CRT (OR 1.59, 95% CI 1.06–2.37) and IMRT (OR 2.22, 95% CI 1.33–3.74) groups had lower bowel QOL using the BT group as a reference at 12 months. In addition, on multivariate analysis of factors that predict a lower EPIC score of the bowel domain at 24 months, the BT + 3D-CRT (OR 1.59, 95% CI 1.02–2.49) and IMRT (OR 1.68, 95% CI 1.002–2.82) groups had lower bowel QOL using the BT group as a reference. Knowledge of changes in QOL outcomes associated with IMRT, BT, and BT + 3D-CRT may influence treatment recommendations and enable patients to make better-informed decisions.

Laparoscopic and robotic-assisted versus open radical prostatectomy for the treatment of localised prostate cancer.

Prostate cancer is commonly diagnosed in men worldwide. Surgery, in the form of radical prostatectomy, is one of the main forms of treatment for men with localised prostate cancer. Prostatectomy has traditionally been performed as open surgery, typically via a retropubic approach. The advent of laparoscopic approaches, including robotic-assisted, provides a minimally invasive alternative to open radical prostatectomy (ORP). To assess the effects of laparoscopic radical prostatectomy or robotic-assisted radical prostatectomy compared to open radical prostatectomy in men with localised prostate cancer. We performed a comprehensive search using multiple databases (CENTRAL, MEDLINE, EMBASE) and abstract proceedings with no restrictions on the language of publication or publication status, up until 9 June 2017. We also searched bibliographies of included studies and conference proceedings. We included all randomised controlled trials (RCTs) with a direct comparison of laparoscopic radical prostatectomy (LRP) and robotic-assisted radical prostatectomy (RARP) to ORP, including pseudo-RCTs. Two review authors independently classified studies and abstracted data. The primary outcomes were prostate cancer-specific survival, urinary quality of life and sexual quality of life. Secondary outcomes were biochemical recurrence-free survival, overall survival, overall surgical complications, serious postoperative surgical complications, postoperative pain, hospital stay and blood transfusions. We performed statistical analyses using a random-effects model and assessed the quality of the evidence according to GRADE. We included two unique studies with 446 randomised participants with clinically localised prostate cancer. The mean age, prostate volume, and prostate-specific antigen (PSA) of the participants were 61.3 years, 49.78 mL, and 7.09 ng/mL, respectively. Primary outcomes We found no study that addressed the outcome of prostate cancer-specific survival. Based on data from one trial, RARP likely results in little to no difference in urinary quality of life (MD -1.30, 95% CI -4.65 to 2.05) and sexual quality of life (MD 3.90, 95% CI -1.84 to 9.64). We rated the quality of evidence as moderate for both quality of life outcomes, downgrading for study limitations. Secondary outcomes We found no study that addressed the outcomes of biochemical recurrence-free survival or overall survival.Based on one trial, RARP may result in little to no difference in overall surgical complications (RR 0.41, 95% CI 0.16 to 1.04) or serious postoperative complications (RR 0.16, 95% CI 0.02 to 1.32). We rated the quality of evidence as low for both surgical complications, downgrading for study limitations and imprecision.Based on two studies, LRP or RARP may result in a small, possibly unimportant improvement in postoperative pain at one day (MD -1.05, 95% CI -1.42 to -0.68 ) and up to one week (MD -0.78, 95% CI -1.40 to -0.17). We rated the quality of evidence for both time-points as low, downgrading for study limitations and imprecision. Based on one study, RARP likely results in little to no difference in postoperative pain at 12 weeks (MD 0.01, 95% CI -0.32 to 0.34). We rated the quality of evidence as moderate, downgrading for study limitations.Based on one study, RARP likely reduces the length of hospital stay (MD -1.72, 95% CI -2.19 to -1.25). We rated the quality of evidence as moderate, downgrading for study limitations.Based on two study, LRP or RARP may reduce the frequency of blood transfusions (RR 0.24, 95% CI 0.12 to 0.46). Assuming a baseline risk for a blood transfusion to be 8.9%, LRP or RARP would result in 68 fewer blood transfusions per 1000 men (95% CI 78 fewer to 48 fewer). We rated the quality of evidence as low, downgrading for study limitations and indirectness.We were unable to perform any of the prespecified secondary analyses based on the available evidence. All available outcome data were short-term and we were unable to account for surgeon volume or experience. There is no high-quality evidence to inform the comparative effectiveness of LRP or RARP compared to ORP for oncological outcomes. Urinary and sexual quality of life-related outcomes appear similar.Overall and serious postoperative complication rates appear similar. The difference in postoperative pain may be minimal. Men undergoing LRP or RARP may have a shorter hospital stay and receive fewer blood transfusions. All available outcome data were short-term, and this study was unable to account for surgeon volume or experience.

Racial or Ethnic and Socioeconomic Disparities in Prostate Cancer Survivors' Prostate-specific Quality of Life

To conduct a prospective study to examine whether there are pretreatment and post-treatment disparities in urinary, sexual, and bowel quality of life (QOL) by race or ethnicity, education, or income in men with clinically localized prostate cancer (PCa.) METHODS: Participants (N = 1508; 81% white; 12% black; 7% Hispanic; 50% surgery; 27% radiotherapy; 23% active surveillance) completed the Expanded Prostate Cancer Index Composite measure of PCa-specific QOL prior to treatment, 6 weeks, 6, 12, 18, and 24 months after treatment. We analyzed pretreatment differences in QOL with multivariable linear regression and post-treatment differences with generalized estimating equation models. Blacks and Hispanics (compared with whites) and men with lower income had worse pretreatment urinary function; poorer and less educated men had worse pretreatment sexual function (P < .05). In adjusted models, among men treated surgically, blacks and Hispanics had worse bowel function compared with whites, and men with lower income experienced more sexual bother and slower recovery in urinary function. Not all racial or ethnic differences favored whites; blacks had higher sexual function than whites prior to surgery and improved faster after surgery. Blacks receiving radiotherapy had lower post-treatment bowel bother than whites (P < .05). Controlling for baseline QOL, there were some post-treatment disparities in urinary and sexual QOL that suggest the need to investigate whether treatment quality and access to follow-up care is equitable. However, survivorship disparities may, to a greater extent, reflect disadvantages in baseline health that exacerbate QOL issues after treatment.

Quality of Life after post-prostatectomy intensity modulated radiation therapy to the prostate bed with or without the use of gold fiducial markers for image guidance or higher total radiotherapy doses.

ABSTRACTPurpose To evaluate quality of life (QoL) after post-prostatectomy intensity modulated radiation therapy (IMRT) in the “adjuvant” setting starting within 4 months of radical prostatectomy for adverse features; and “salvage” setting for a PSA≥0.2ng/mL.Materials and Methods Retrospective review of 130 patients who underwent IMRT to the prostate bed±gold fiducial marker placement for image guidance to 64.8-72.0Gy (median, 70.2Gy) between 2004 and 2013. Higher doses were defined as 70.2-72.0Gy and lower doses were defined as 64.8-68.4Gy. Androgen deprivation therapy (ADT) was given to 4/48 (8%) adjuvant patients and 9/82 (11%) salvage patients. International Prostate Symptom Score (IPSS), Sexual Health Inventory for Men (SHIM), and Expanded Prostate Cancer Index Composite-26-bowel (EPIC-26-bowel) questionnaires were used to assess urinary, sexual, and bowel QoL, respectively.Results Median follow-up was 46 months. There were better urinary (p=0.03) and sexual (p=0.002) QoL scores with adjuvant IMRT relative to salvage IMRT. The use of prostate bed fiducial markers did not significantly affect urinary, sexual, or bowel QoL (p=0.39, p=0.49, and p=0.40, respectively). Higher total radiotherapy doses did not significantly affect urinary, sexual, or bowel QoL (p=0.21, p=0.61, and p=0.36, respectively).Conclusions There was no significant change in urinary, sexual, and bowel sexual QoL with post-prostatectomy IMRT regardless of whether prostate bed fiducial markers or higher total radiotherapy doses were used. QoL with IMRT in the present study compares favorably with prior reports for three-dimensional conformal radiation therapy.

Effects of barbed suture during robot-assisted radical prostatectomy on postoperative tissue damage and longitudinal changes in lower urinary tract outcome.

To compare the postoperative tissue damage and longitudinal changes in functional and patient-reported outcomes after vesicourethral anastomosis with barbed suture and nonbarbed suture in robot-assisted laparoscopic radical prostatectomy (RARP). This was a prospective cohort study involving 88 consecutive patients who underwent RARP. These patients were categorized into the barbed suture group (n=50) and the nonbarbed suture group (n=38). Urethral and periurethral damages determined by magnetic resonance imaging at nine months after RARP were compared using generalized linear models. The International Prostate Symptom Score (IPSS), quality of life (QOL) index, uroflowmetry, and the 1-h pad test were measured at baseline and at 1, 3, 6, 9, and 12months after RARP. The findings were analyzed using mixed-effects models. Confounding was adjusted for using propensity score covariate adjustment. The likelihood of having Grade 2/3 urethral and periurethral damages was greater in the barbed suture group than in the nonbarbed suture group (adjusted risk ratios: 2.98 and 3.85, respectively). IPSS, QOL index, and urinary leakage transiently increased at one month after RARP in both groups. QOL index was higher in the barbed suture group than in the nonbarbed suture group at 1, 9, and 12months (P=0.023, P=0.025, and P=0.011, respectively). The barbed suture group had significantly more cases of urinary incontinence than the nonbarbed suture group at 3months (P=0.041). Other outcomes were comparable between the two groups at all time points. This cohort study showed that, after RARP, barbed sutures during VUA induced more severe tissue damage as determined by MRI and greater transient aggravation of QOL and continence function than nonbarbed sutures. The present findings suggest that using nonbarbed sutures during VUA may facilitate earlier acquisition of urinary QOL and urinary continence.

Community-based Outcomes of Open versus Robot-assisted Radical Prostatectomy

BackgroundIdentifying the optimal surgical approach for patients with localized prostate cancer (PCa) managed in the community setting remains controversial due to the lack of robust, prospective data. ObjectiveTo assess surgical outcomes and changes in urinary and sexual quality of life (QOL) over time in patients undergoing radical prostatectomy (RP). Design, setting, and participantsOur study included patients enrolled in Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE), a large, prospective, mostly community-based, nationwide PCa registry, who underwent RP between 2004 and 2016. InterventionOpen (ORP) versus robot-assisted radical prostatectomy (RARP) for localized PCa. Outcome measurements and statistical analysisDemographic and clinicopathologic data and surgical outcomes were compared between ORP and RARP. Self-reported, validated questionnaires (scaled 0–100 with higher numbers indicating better function) were used to evaluate urinary and sexual QOL at different time points. Repeated measures mixed-models assessed changes in function and bother over time in each domain. Results and limitationsAmong 1892 men (n = 1137 ORP; n = 755 RARP), Cancer of the Prostate Risk Assessment score, Gleason grade at biopsy and RP, and pT-stage were lower in ORP patients (all p < 0.01). Men undergoing RARP had comparable surgical margin rates, lymph node yields, and biochemical recurrence rates. In a subset analysis with 1451 men reporting baseline and follow-up QOL data, ORP patients reported superior scores in urinary incontinence (ORP mean ± standard deviation 69 ± 26 vs RARP 62 ± 27) and bother (ORP 75±29 vs RARP 68±28, both p < 0.01) only in the 1st yr after RP. Differences in sexual outcomes did not differ between groups, nor did any QOL scores beyond 1 yr. Limitations include a decrease in the rate of questionnaire response during follow-up, potential selection biases in terms of patient assignment to ORP versus RARP and survey completion rates, and the fact that RARP cases likely included the initial learning curve for the CaPSURE surgeons. ConclusionsMost patients experienced changes in urinary and sexual QOL in the 1st 3 yr following RP. The pattern of recovery over time was similar between ORP and RARP groups. Patients should not expect different oncologic or QOL outcomes based on surgical approach. Patient summaryAside from a small, early, and temporary advantage in terms of urinary incontinence and bother favoring open surgery, minimal differences in outcomes are observed when comparing men who undergo open versus robot-assisted prostatectomy in the community setting.

Long-Term Quality of Life in Prostate Cancer Patients Treated With Cesium-131

Toevaluate long-term patient-reported quality of life (QOL) scores in men with prostate cancer treated at our institution with 131Cs prostate brachytherapy. Patients treated more than 4years ago with 131Cs (n=290) were asked to fill out an Expanded Prostate Cancer Index Composite (EPIC) QOL questionnaire and American Urological Association Symptom Score (AUASS) survey, before treatment and at each follow-up appointment. We compared patients' EPIC and AUA scores at baseline with scores at a last follow-up of at least 4years after treatment using the Wilcoxon signed-rank test. At a median last follow-up of 5.5years after treatment with 131Cs prostate brachytherapy there were no clinically significant changes in the EPIC or AUA scores from baseline. There was statistical worsening in the EPIC urinary incontinence subscore. Subset analyses revealed improved QOL outcomes in patients who received external beam radiation therapy or α-blocker therapy, whereas androgen deprivation therapy was not associated with differences in QOL change. Our results demonstrate minimal long-term changes in urinary or bowel patient-reported QOL with 131Cs prostate brachytherapy. These findings suggest that patients treated with this isotope are able to recover and then maintain their baseline QOL in the long term.

Patient-reported Quality of Life After Proton Beam Therapy for Prostate Cancer: The Effect ofProstate Size.

In the present study, we assessed the effect of prostate gland size on patient-assessed genitourinary and gastrointestinal (GI) quality of life (QOL) after definitive treatment of prostate adenocarcinoma with proton beam therapy. As a part of a prospective outcome tracking protocol, 81 patients treated at a single center between with proton beam therapy completed the Expanded Prostate Cancer Index Composite (EPIC) questionnaire before treatment and at the follow-up examinations. We reviewed the dosimetric data, reported as Vx (volume of organ receiving x Gy), and patient-reported QOL at 6 months. Genitourinary QOL was assessed using the American Urological Association symptom score and EPIC urinary domain score. GI QOL was assessed using the EPIC GI domain score. Larger prostate glands were associated with greater bladder V70 (P< .01) and rectal V70 (P< .01). The rectal V70 was< 15% for all patients (range, 4%-13.8%) with the planned treatment volume coverage (percentage of the prescription dose covering 95% of the volume > 95%) maintained. Patients with larger prostates did not have a greater change in their American Urological Association symptom index scores (< 30 cm3,+2.3; 30-49 cm3,+3.2;≥ 50 cm3, 0.2; P= .06) or urinary domain score (< 30 cm3,-3.6; 30-49 cm3,-3.1;≥ 50 cm3,+3.8; P= .76) at 6 months after treatment. Also, prostate size was not associated with a change in the EPIC GI domain score at 6 months after treatment (< 30 cm3,-3.7; 30-49 cm3,-1.1;≥ 50 cm3,-0.55; P= .67). Definitive proton beam therapy for prostate cancer to a dose of 79.2 Gy resulted in excellent patient-reported urinary and GI QOL, independently of the baseline prostate size. This single-institution finding should be tested further in a multi-institutional study to confirm the potential limited role of androgen deprivation therapy.

Pelvic SABR with HDR boost in intermediate- and high-risk prostate cancer (SPARE): Favorable early toxicity and quality-of-life outcomes.

60 Background: ASCENDE-RT has provided level 1 evidence supporting the use of androgen deprivation therapy (ADT), external beam radiotherapy and brachytherapy boost in intermediate- and high-risk prostate cancer. The objectives of this study are to report early toxicity and quality of life (QOL) outcomes in patients treated on a hybrid protocol using five-fraction pelvic stereotactic ablative radiotherapy (SABR) with a MRI dose painted HDR brachytherapy boost (HDR-BT). Methods: A phase I/II study was performed where intermediate (IR) and high-risk (HR) prostate cancer patients received HDR-BT 15Gy in single fraction to the prostate and up to 22.5Gy to the MRI nodule. Gantry-based 25Gy SABR was delivered to pelvis, seminal vesicles and prostate in 5 weekly fractions. ADT was used for 6-18 months. Common Terminology Criteria for Adverse Events version 3.0 was used to assess toxicities. QOL was captured using EPIC at every follow-up. A minimally clinically important change (MCIC) definition was triggered if the EPIC QOL score at each time point decreases &gt; 0.5 SD, where SD is the standard deviation of baseline scores. Results: Thirty-three patients (NCCN 6.0% low IR, 45.5% high IR and 48.5% HR) completed this treatment with a median follow-up of 13.8 months (IQR 12.1, 18.8). The incidence of worst toxicities is shown in Table 1.The 3 grade 3 GU patients were due to temporary urinary catheterization in the acute period following HDR-BT. Mean (95% SD) EPIC urinary QOL scores were 82.5 (16.5), 83.2 (12.9) and 83.7 (16.3) at baseline, 3 months and 12 months and the bowel scores were 95.9 (3.8), 92.6 (8.2) and 90.5 (8.3), respectively. Proportion of patients experiencing MCIC at 3 months and 12 months were 20.8% and 14.3% for urinary domain, 47.8% and 53.9% for bowel domain; respectively (see Table). Conclusions: This novel treatment protocol incorporating MRI dose painted HDR brachytherapy boost and SABR pelvic radiation for intermediate- and high-risk prostate cancer in combination with ADT is feasible and well tolerated in the acute setting. Clinical trial information: REB 269-2014. [Table: see text]

Continued Benefit to Rectal Separation for Prostate Radiation Therapy: Final Results of a Phase III Trial

SpaceOAR, a Food and Drug Administration-approved hydrogel intended to create a rectal-prostate space, was evaluated in a single-blind phase III trial of image guided intensity modulated radiation therapy. A total of 222 men were randomized 2:1 to the spacer or control group and received 79.2Gy in 1.8-Gy fractions to the prostate with or without the seminal vesicles. The present study reports the final results with a median follow-up period of 3years. Cumulative (Common Terminology Criteria for Adverse Events, version 4.0) toxicity was evaluated using the log-rank test. Quality of life (QOL) was examined using the Expanded Prostate Cancer Index Composite (EPIC), and the mean changes from baseline in the EPIC domains were tested using repeated measures models. The proportions of men with minimally important differences (MIDs) in each domain were tested using repeated measures logistic models with prespecified thresholds. The 3-year incidence of grade ≥1 (9.2% vs 2.0%; P=.028) and grade ≥2 (5.7% vs 0%; P=.012) rectal toxicity favored the spacer arm. Grade ≥1 urinary incontinence was also lower in the spacer arm (15% vs 4%; P=.046), with no difference in grade ≥2 urinary toxicity (7% vs 7%; P=0.7). From 6months onward, bowel QOL consistently favored the spacer group (P=.002), with the difference at 3years (5.8 points; P<.05) meeting the threshold for a MID. The control group had a 3.9-point greater decline in urinary QOL compared with the spacer group at 3years (P<.05), but the difference did not meet the MID threshold. At 3years, more men in the control group than in the spacer group had experienced a MID decline in bowel QOL (41% vs 14%; P=.002) and urinary QOL (30% vs 17%; P=.04). Furthermore, the control group were also more likely to have experienced large declines (twice the MID) in bowel QOL (21% vs 5%; P=.02) and urinary QOL (23% vs 8%; P=.02). The benefit of a hydrogel spacer in reducing the rectal dose, toxicity, and QOL declines after image guided intensity modulated radiation therapy for prostate cancer was maintained or increased with a longer follow-up period, providing stronger evidence for the benefit of hydrogel spacer use in prostate radiation therapy.

Functional Outcomes and Quality of Life After Radical Prostatectomy Only Versus a Combination of Prostatectomy with Radiation and Hormonal Therapy

BackgroundWhile the optimal use and timing of secondary therapy after radical prostatectomy (RP) remain controversial, there are limited data on patient-reported outcomes following multimodal therapy. ObjectiveTo assess the impact of additional radiation therapy (RT) and/or androgen deprivation therapy (ADT) on urinary continence, potency, and quality of life (QoL) after RP. Design, setting, and participantsAmong 13150 men who underwent RP from 1992 to 2013, 905 received RP + RT, 407 RP + ADT and 688 RP + RT + ADT. Outcome measurements and statistical analysesUrinary function, sexual function, and overall QoL were evaluated annually using self-administered validated questionnaires. Propensity score–matched and bootstrap analyses were performed, and the distributions for all functional outcomes were analyzed as a function of time after RP. Results and limitationsPatients who received RP + RT had a 4% higher overall incontinence rate 3 yr after surgery, and 1% higher rate for severe incontinence (>3 pads/24h) compared to matched RP-only patients. ADT further increased the overall and severe incontinence rates by 4% and 3%, respectively, compared to matched RP + RT patients. RP + RT was associated with an 18% lower rate of potency compared to RP alone, while RP + RT + ADT was associated with a further 17% reduction compared to RP + RT. Additional RT reduced QoL by 10% and additional ADT by a further 12% compared to RP only and RP + RT, respectively. The timing of RT after RP had no influence on continence, but adjuvant compared to salvage RT was associated with significantly lower potency (37% vs 45%), but higher QoL (60% vs 56%). Limitations of our study include the observational study design and potential for selection bias in the treatments received. ConclusionsSecondary RT and ADT after RP have an additive negative influence on urinary function, potency, and QoL. Patients with high-risk disease should be counseled before RP on the potential net impairment of functional outcomes due to multimodal treatment. Patient summaryMen with high-risk disease choosing surgery upfront should be counseled on the potential need for additional radiation and or androgen deprivation, and the potential net impairment of functional outcomes arising from multimodal treatment.

24-month durability after crossover to the prostatic urethral lift from randomised, blinded sham.

To evaluate the 24-month effectiveness of the prostatic urethral lift (PUL) procedure in men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) assessed through a crossover study. In all, 53 patients underwent a sham procedure as part of the blinded, randomised L.I.F.T. (Luminal Improvement Following prostatic Tissue approximation for the treatment of LUTS secondary to BPH) study at 19 centres and elected to enrol in this crossover study. The crossover procedure involved placement of permanent implants (UroLift® system) into the prostatic lateral lobes. Patients were followed for 3months after the sham procedure and then for 24months after crossover to PUL, with assessments of urinary symptom relief, quality of life (QoL), urinary flow rate, sexual function, and adverse events. At 24months after crossover to PUL, the International Prostate Symptom Score (IPSS), QoL, BPH Impact Index, and maximum urinary flow rate improved 36%, 40%, 54%, and 77% from baseline, respectively. Each IPSS parameter on average improved significantly from baseline (P<0.005) and remained stable throughout follow-up. Symptom response after the sham procedure indicated initial improvement at 1month with significant decay by 3months. Adverse events were typically mild to moderate and patients returned rapidly to normal activity. Four patients (8%) required intervention with transurethral resection of the prostate and one patient required additional PUL implants within the 24-month period. There were no reported instances of de novo sustained erectile or ejaculatory dysfunction. The PUL procedure is associated with rapid symptom relief, increased urinary flow rate and QoL improvement that remain stable over 24months. Morbidity is low and sexual function is preserved.

Doxazosin oral intake therapy to relieve stent - related urinary symptoms and pain: a prospective, randomized, controlled study.

ABSTRACTObjective:To assess the impact of Doxazosin Oral Intake Therapy on urinary symptoms and pain in patients with indwelling ureteral stentsPatients and Methods:A total of 239 patients with ureteral stone-related hydronephrosis who underwent a double-J stent insertion after ureteroscopic lithotripsy were enrolled. Patients were randomized to receive doxazosin cotrolled release 4 mg once daily for 4 weeks or matching placebo. Patients completed the brief-form Chinese version Ureteric Stent Symptom Questionnaire (USSQ) and quality of life (QoL) score 2 weeks and 4 weeks after stent placement and 4 weeks after stent withdrawal. The analgesic use was also recorded during the stenting period.Results:Patients in Doxazosin Oral Intake Therapy group, in the first 2 weeks and second 2 weeks with the stent in situ, expressed significant lower daytime frequency (p=0.028 and p=0.038), nocturia (p=0.021 and p=0.008) and urgency (p=0.012 and p=0.014), respectively. Similarly, flank pain score, QoL score and analgesic use were also significant less in the stenting period. There was no significant difference in scores of urinary symptoms, pain and QoL during the post-stent period between two cohorts.Conclusions:Doxazosin Oral Intake Therapy reduced stent-related urinary symptoms, pain and the negative impact on QoL.