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"Lower Urinary Tract Symptoms"
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Transurethral Resection of the Prostate (TURP) Versus Original and PErFecTED Prostate Artery Embolization (PAE) Due to Benign Prostatic Hyperplasia (BPH): Preliminary Results of a Single Center, Prospective, Urodynamic-Controlled Analysis
2016
Purpose
To compare clinical and urodynamic results of transurethral resection of the prostate (TURP) to original and PErFecTED prostate artery embolization (PAE) methods for benign prostatic hyperplasia.
Methods
We prospectively randomized 30 patients to receive TURP or original PAE (oPAE) and compared them to a cohort of patients treated by PErFecTED PAE, with a minimum of 1-year follow-up. Patients were assessed for urodynamic parameters, prostate volume, international prostate symptom score (IPSS), and quality of life (QoL).
Results
All groups were comparable for all pre-treatment parameters except bladder contractility and peak urine flow rate (
Q
max
), both of which were significantly better in the TURP group, and IIEF score, which was significantly higher among PErFecTED PAE patients than TURP patients. All groups experienced significant improvement in IPSS, QoL, prostate volume, and
Q
max
. TURP and PErFecTED PAE both resulted in significantly lower IPSS than oPAE but were not significantly different from one another. TURP resulted in significantly higher
Q
max
and significantly smaller prostate volume than either original or PErFecTED PAE but required spinal anesthesia and hospitalization. Two patients in the oPAE group with hypocontractile bladders experienced recurrence of symptoms and were treated with TURP. In the TURP group, urinary incontinence occurred in 4/15 patients (26.7 %), rupture of the prostatic capsule in 1/15 (6.7 %), retrograde ejaculation in all patients (100 %), and one patient was readmitted for temporary bladder irrigation due to hematuria.
Conclusions
TURP and PAE are both safe and effective treatments. TURP and PErFecTED PAE yield similar symptom improvement, but TURP is associated with both better urodynamic results and more adverse events.
Journal Article
Randomised controlled trial to investigate the effectiveness of the symptom management after radiotherapy (SMaRT) group intervention to ameliorate lower urinary tract symptoms in men treated for prostate cancer
by
Otter, Sophie
,
Lemanska, Agnieszka
,
Faithfull, Sara
in
Analysis
,
Analysis of covariance
,
Cancer
2022
Purpose
To evaluate the effectiveness of the symptom management after radiotherapy (SMaRT) group intervention to improve urinary symptoms in men with prostate cancer.
Methods
The randomised controlled trial (RCT) recruited men from one radiotherapy centre in the UK after curative radiotherapy or brachytherapy and with moderate to severe urinary symptoms defined as scores ≥ 8 on the International Prostate Symptom Score (IPSS) questionnaire. Sixty-three men were randomised either; to SMaRT, a 10-week symptom-management intervention including group support, education, pelvic floor muscle exercises, or a care-as-usual group. The primary outcome was the IPSS at 6 months from baseline assessment. Secondary outcomes were IPSS at 3 months, and International Continence Society Male Short Form (ICS), European Organisation for Research and Treatment of Cancer Quality of Life prostate scale (EORTC QLQ-PR25), EORTC QLQ-30 and Self-Efficacy for Symptom Control Inventory (SESCI) at 3 and 6 months from baseline. Analysis of covariance (ANCOVA) was used to analyse the effect of the intervention.
Results
SMaRT group intervention did not improve urinary symptoms as measured by IPSS at 6-months. The adjusted difference was − 2.5 [95%CI − 5.0 to 0.0],
p
= 0.054. Significant differences were detected at 3 months in ICS voiding symptoms (− 1.1 [− 2.0 to − 0.2],
p
= 0.017), ICS urinary incontinence (− 1.0 [− 1.8 to − 0.1],
p
= 0.029) and SESCI managing symptoms domain (13.5 [2.5 to 24.4],
p
= 0.017). No differences were observed at 6 months.
Conclusions
SMaRT group intervention provided short-term benefit in urinary voiding and continence and helped men manage symptoms but was not effective long term.
Journal Article
Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM) for diagnosis and management of bladder outlet obstruction in men: study protocol for a randomised controlled trial
2015
Background
Lower urinary tract symptoms (LUTS) comprise storage symptoms, voiding symptoms and post-voiding symptoms. Prevalence and severity of LUTS increase with age and the progressive increase in the aged population group has emphasised the importance to our society of appropriate and effective management of male LUTS. Identification of causal mechanisms is needed to optimise treatment and uroflowmetry is the simplest non-invasive test of voiding function. Invasive urodynamics can evaluate storage function and voiding function; however, there is currently insufficient evidence to support urodynamics becoming part of routine practice in the clinical evaluation of male LUTS.
Design
A 2-arm trial, set in urology departments of at least 26 National Health Service (NHS) hospitals in the United Kingdom (UK), randomising men with bothersome LUTS for whom surgeons would consider offering surgery, between a care pathway based on urodynamic tests with invasive multichannel cystometry and a care pathway based on non-invasive routine tests. The aim of the trial is to determine whether a care pathway not including invasive urodynamics is no worse for men in terms of symptom outcome than one in which it is included, at 18 months after randomisation. This primary clinical outcome will be measured with the International Prostate Symptom Score (IPSS). We will also establish whether inclusion of invasive urodynamics reduces rates of bladder outlet surgery as a main secondary outcome.
Discussion
The general population has an increased life-expectancy and, as men get older, their prostates enlarge and potentially cause benign prostatic obstruction (BPO) which often requires surgery. Furthermore, voiding symptoms become increasingly prevalent, some of which may not be due to BPO. Therefore, as the population ages, more operations will be considered to relieve BPO, some of which may not actually be appropriate. Hence, there is sustained interest in the diagnostic pathway and this trial could improve the chances of an accurate diagnosis and reduce overall numbers of surgical interventions for BPO in the NHS. The morbidity, and therapy costs, of testing must be weighed against the cost saving of surgery reduction.
Trial registration
Controlled-trials.com -
ISRCTN56164274
(confirmed registration: 8 April 2014).
Journal Article
Efficacy of High-Dose Dexamethasone in Reducing the Symptoms of Postembolization Syndrome Following Prostatic Artery Embolization: Results of a Double-Blind Randomized Controlled Trial
by
Røder, Andreas
,
Lonn, Lars
,
Svarc, Petra
in
C-reactive protein
,
Clinical trials
,
Dexamethasone
2024
PurposeTo evaluate the efficacy of a single perioperative dose of dexamethasone in reducing postembolization syndrome following prostatic artery embolization.Materials and MethodsWe conducted a single-center double-blind randomized controlled trial from March 2021 to May 2022 (NCT04588857). Participants were randomized to receive either i.v. 24 mg dexamethasone or saline. The primary outcome measures were temperature, pain, and quality of life in the first 5 days following prostatic artery embolization. Sample size of 60 patients was needed for the assessment of primary outcomes. Participants were followed for 6 months and assessed for a variety of secondary outcome measures including inflammatory markers and lower urinary tract symptoms severity.ResultsDue to lack of clinical effect and mild symptoms in the control group, the trial was terminated early. 31 participants (16 dexamethasone vs. 15 control) were enrolled and analyzed. A difference in mean temperature was observed on day 1 (37.23 ± 0.64 °C control vs 36.74 ± 0.41 °C dexamethasone, p = 0.02, 95% CI 0.09–0.89). Difference in pain (score out of 10) was seen only on day 5 (1.48 ± 1.2 control vs. 2.9 ± 2.24 dexamethasone, p = 0.04, 95% CI − 2.78–− 0.04). A difference in C-reactive protein values was observed on day 2 (108 [54–161] mg/l control vs 10 [5–33] mg/l dexamethasone, p < 0.01). No significant differences in other outcomes were observed. No side effects were recorded.ConclusionsTwenty-four milligrams of dexamethasone bolus is safe but does not reduce postembolization syndrome following prostatic artery embolization.
Journal Article
Reverse placement of a double J ureteral stent improves lower urinary tract symptoms
2025
Objective
To investigate the clinical efficacy and patient-reported discomfort associated with traditional versus reverse placement of double-J ureteral stents (DJUS) in patients undergoing ureteroscopic stone removal.
Materials and methods
This prospective, randomized, single-center, one blinded, controlled study. In the control group, the double-J stent was placed with its upper end facing laterally (towards the kidney) and its lower end facing medially (towards the bladder trigone), while in the study group, the reverse was done in a mirror manner. Patients in the study group were further subdivided based on the orientation of the upper and lower tips of the stent (B1: upper medial/lower lateral, B2: both medial, B3: both lateral). Patient discomfort was assessed using the Turkish version of the Ureteral Stent Symptom Questionnaire (T-USSQ), and secondary outcomes included postprocedural hydronephrosis, hematuria, and urinary tract infection.
Results
A total of 120 patients were included and 60 patients to each the control and study groups. Forty patients were included in group B1, 8 in B2 and 12 in B3. The reverse placement group (Group B) reported significantly lower USSQ (
p
< 0.05) and reduced analgesic use compared to the control group. Midline crossing of the stent was significantly less frequent in the study group (11.7% vs. 30%;
p
= 0.013). Subgroup analysis revealed that the B1 and B3 groups had significantly lower analgesic usage and symptom scores compared to the control group, while the B2 group reported higher hydronephrosis and symptom scores.
Conclusion
Reverse placement of DJUS, particularly when both stent ends are laterally positioned, may reduce stent-related discomfort. There is a need for a new stent design with both ends facing laterally, tentatively named “ipsi-DJUS”.
Trial registration
Turning the tip of the stent upside down may ease urinary symptoms” is now listed on the ISRCTN registry with study registration number ISRCTN17937257 (Date of registration: 22/10/2024). Retrospectively registered.
Journal Article
B3 agonists or anticholinergics in the treatment of the lower urinary tract dysfunction in patients with multiple sclerosis?—A randomized study
2021
Introduction and objectiveMultiple sclerosis (MS) is the most frequent autoimmune demyelinating disease of the central nervous system. MS patients usually present with lower urinary tract dysfunction (LUTD). Objective of this study is to evaluate and compare the efficacy and safety of treating MS patients with LUTD with either a b3 agonist (mirabegron) or anticholinergics. The study’s primary outcome is the LUTD symptom improvement. Material and MethodsThis is a multi-center, single-blinded, comparative study including 91 MS patients with LUTD. At baseline, patients underwent thorough clinical examination, urine cultivation and abdominal ultrasound and completed urination diaries and specific, validated questionnaires (NBSS, MusiQoL). At second visit, patients were administered either mirabegron or anticholinergics. Treatment was always carried out alongside with MS treatment. Reevaluation was performed 3 months after first visit. Patients underwent the same clinical and imaging tests that were carried out at first visit.ResultsWe compared several clinical and imaging parameters between the two groups at first visit and month 3 after treatment. Νo statistical difference was noted between the mirabegron group and the anticholinergic group in terms of LUTD improvement. In both groups, improvement from baseline regarding LUTD was recorded. Statistical analysis was performed using the paired and unpaired t test method. No patient discontinued either medication due to side effects.ConclusionsMS patients receiving either mirabegron or anticholinergic therapy for LUTD showed improvement. Nevertheless, no statistical difference was noted between the two cohorts at 3 months in terms of drug efficacy in all the statistically significant parameters.
Journal Article
Study protocol for a single-centre non-inferior double-blinded randomised controlled trial in China comparing the efficacy and safety of high-frequency irreversible electroporation with transurethral resection of the prostate in treating lower urinary tract symptoms and benign prostatic obstruction (the GIANT trial)
2025
IntroductionTransurethral resection of the prostate (TURP) is the gold standard surgical treatment to lower urinary tract symptoms and benign prostatic obstruction (LUTS/BPO). Although it has been proven to have substantial efficacy in improving functional outcomes, it has shown a high incidence of complications, including transurethral resection syndrome, massive bleeding, urinary incontinence and sexual dysfunction. High-frequency irreversible electroporation (H-FIRE) is a novel non-thermal ablation technique that delivers pulsed high-voltage but low-energy electric current to the cell membrane, thereby leading to cell death. H-FIRE has been reported to be tissue-selective, which leads to fewer side effects. However, no data are available on whether H-FIRE is non-inferior compared with TURP in treating patients with LUTS/BPO regarding safety and efficacy.Methods and analysisThis trial is a prospective, single-centre, randomised controlled, double-blinded and non-inferiority study in which all men with LUTS/BPO are included. This study aims to determine whether the HI-FIRE is non-inferior to TURP for achieving better functional outcomes as measured by the co-primary outcome of the change from baseline in maximal flow rate (Qmax) and the urinary symptoms by questionnaire of International Prostate Symptom Score (IPSS) scoring at 3 months after surgical treatment. The main inclusion criteria are men with prostatic volume range 30 to 100 mL, Qmax<15 mL/s and IPSS>8. A sample size of 118 participants is required, accounting for a 20% loss. All participants will be randomly allocated at a ratio of 1:1 to the H-FIRE arm (n=59) and the TURP arm (n=59). The primary outcome is to assess the change from baseline in Qmax and IPSS scoring at 3 months after surgical treatment.Ethics and disseminationEthical approval was obtained from the ethics committee of Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China. The results of the study will be disseminated and published in international peer-reviewed journals.Trial registration numberClinicalTrials.gov: NCT05306145.
Journal Article
Thulium: YAG vs continuous-wave thulium fiber laser enucleation of the prostate: do potential advantages of thulium fiber lasers translate into relevant clinical differences?
2023
PurposeTo compare endoscopic enucleation of the prostate using a thulium: yttrium–aluminum–garnet (Tm:YAG) laser and a super-pulsed thulium fiber laser set in continuous-wave (CW) mode, and to evaluate whether theoretical advantages of thulium fiber lasers, related to their shorter wavelength, translate into relevant clinical differences.MethodsIn total, 110 patients suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia were randomized to undergo either thulium:YAG laser enucleation of the prostate (ThuLEP) or CW thulium fiber laser enucleation of the prostate (CW-ThuFLEP). Intraoperative and postoperative variables and complications were compared. Micturition improvement was assessed at 3-month follow-up using the International Prostate Symptom Score (IPSS), post-void residual urine (PVR) and maximum flow rate (Qmax). Erectile function was evaluated using the International Index of Erectile Function-5 (IIEF-5).ResultsNo significant differences between the ThuLEP and CW-ThuFLEP groups were found in terms of operative time (70.69 vs 72.41 min), enucleation time (50.23 vs 53.33 min), enucleated tissue weight (40.2 vs 41.9 g), enucleation efficiency (0.80 vs 0.79 g/min), catheterization time (2.45 vs 2.57 days), hospital stay (2.82 vs 2.95 days) and hemoglobin drop (1.05 vs 1.27 g/dl). At 3-month follow-up, no significant differences were found in IPSS (5.09 vs 5.81), Qmax (26.51 vs 27.13 ml/s), PVR (25.22 vs 23.81 ml) and IIEF-5 (14.01 vs 14.54).ConclusionThuLEP and CW-ThuFLEP were equivalent in relieving patients from LUTS and improving micturition. Theoretical advantages of the TFL, such as shallower penetration depth and improved vaporization capacity, did not translate into relevant perioperative outcomes or clinical differences.
Journal Article
Diagnosis and management of bladder bowel dysfunction in children with urinary tract infections: a position statement from the International Children’s Continence Society
2018
BackgroundWe present a consensus view from the International Children’s Continence Society (ICCS) on the evaluation and management of bladder bowel dysfunction (BBD) in children with urinary tract infection (UTI). The statement aims to highlight the importance of BBD in the development and recurrence of childhood UTI and its management to reduce its associated morbidity and sequelae.MethodsA systematic literature search was done on PubMed, Embase, and Scopus databases until August 15, 2016. Relevant publications concerning BBD and its relationship with UTI among children were reviewed and aggregated for statements of recommendation. Discussion by the ICCS Board and a multi-disciplinary core group of authors resulted in a document available on its website for all ICCS members to review. Insights and feedback were considered with consensus and agreement reached to finalize this position statement.ResultsBBD in children with UTI is summarized. Details regarding epidemiology, pathophysiology, and recommendations for general and family practitioners and pediatricians relating to the evaluation and management of this condition are presented.ConclusionsThis document serves as the position statement from ICCS, based on literature review and expert opinion providing our current understanding of BBD in children with UTI.
Journal Article
Pelvic floor muscle training adapted for urinary incontinence in multiple sclerosis: a randomized clinical trial
by
Pérez, Denise Cuevas
,
de la Llave Rincón Ana Isabel
,
Walker, Chao Carolina
in
Clinical trials
,
Interferon
,
Multiple sclerosis
2020
Introduction and hypothesisLower urinary tract symptoms (LUTS) affect up to 80% of patients with multiple sclerosis (MS). The present randomized, open-label, clinical trial examines the effectiveness, as a conservative treatment for LUTS, of a physiotherapist-guided pelvic floor muscle training (PFMT) program adapted for patients with relapsing-remitting multiple sclerosis (RRMS) and urinary incontinence (UI).MethodsForty-eight patients with RRMS were randomly assigned to a 12-week PFMT program with or without physiotherapist guidance. The primary endpoint was the reduction in urinary leakages after 12 weeks of following the program. The secondary variables assessed were quality of life (QoL), UI severity, LUTS, and treatment adherence.ResultsForty patients completed the program. No significant differences in baseline characteristics were seen between the two treatment groups. At 12 weeks, both groups reported a significantly reduced number of leakages compared with baseline (P < 0.001), with no significant differences seen between groups (P = 0.210). In the physiotherapist-guided group, significant differences were found in QoL, UI severity, and LUTS between baseline and 12 weeks, for both male and female subjects. No significant differences in adherence were seen between the two treatment groups.ConclusionsNo difference in leakage reduction was seen between physiotherapist-guided and unguided PFMT. However, the physiotherapist-guided program was associated with improvements in UI severity, QoL, and LUTS in women and men. The guided PFMT group also showed a trend towards better adherence to treatment.Clinical trial registrationNo. NCT03000647; Title: “Guided Versus Non-Guided Pelvic Floor Exercises for Urinary Incontinence in Relapsing-Remitting Multiple Sclerosis.”
Journal Article