ABSTRACT
PURPOSE: Ejaculatory dysfunction is the most common side effect of benign prostatic hyperplasia surgery. Modified techniques have emerged with the aim of preserving antegrade ejaculation without compromising obstruction relief. None are standardized or validated. The PARTURP study is a randomized study investigating partial versus complete prostate resection. We conducted an investigator consensus meeting to define the ideal surgical technique to achieve both correct obstruction relief with ejaculation preservation. METHODS: An expert consensus meeting involving all investigators of the PARTURP study took place to define a common technique using the nominal group methodology. The objectives were to define the areas to be resected and the areas to be preserved; to define the criteria for proper obstruction relief; to define the criteria for proper ejaculation preservation. RESULTS: All investigators (n = 15) attended the consensus meeting, and agreement between all the participants was obtained. The anatomical landmarks to be preserved are located around the verumontanum and along the posterior part of the prostatic urethra. These structures must be preserved up to 2 cm from the verumontanum. The participants agreed on the need to preserve the urethral mucosa in all the areas to be preserved and to reach the enucleation plane in the areas of resection. CONCLUSIONS: Anatomical landmarks for ejaculation-sparing surgery have been defined by the investigators of the PARTURP randomized study. These landmarks will be used during the study, and the clinical outcomes of this ejaculation-sparing technique will be compared with complete resection with up to 3 years follow-up.
Subject(s)
Prostate , Prostatic Hyperplasia , Male , Humans , Prostate/surgery , Ejaculation , Prostatectomy/methods , EndoscopyABSTRACT
PURPOSE: To assess the efficacy and safety of intravesical instillation of high molecular weight sodium hyaluronate (HMW-HA) for the treatment of radiation-induced cystitis. METHODS: This prospective cohort study was conducted in seven centers in France. Eligible patients with radiation-induced cystitis were recruited between April 2020 and March 2021. A sterile disposable 50 ml prefilled solution containing 0.16% (80 mg/50 mL) HMW-HA (INSTYLAN) was instilled weekly into the bladder. The treatment consisted of 6 sessions (V1 to V6). Outcomes were assessed 1 week (V7) and 4 weeks (V8) after the last session and were compared with baseline (V0). The primary endpoint was bladder pain, evaluated by a Questionnaire with 5 closed-ended response options. Secondary endpoints included changes from baseline for hematuria, urinary frequency, and the effect of urgencies on Quality of Life (QoL). Adverse events (AEs) were graded according to the CTCAE 3.0 classification. RESULTS: A total of 30 participants were enrolled. The Intent-to-Treat analysis showed a significant reduction in pelvic pain intensity (- 45.81%, p < 0.001), hematuria (- 26.87%, p = 0.008), total 24 h voids (- 23.92%, p < 0.001) and the effect of urgencies on QoL (- 33.92%, p < 0.001) at V7. The improvement for each outcome remained stable during the post-therapeutic period between V7 and V8. Bladder instillation therapy was well-tolerated: two treatment-related AEs (6.6%) were reported corresponding to two grade 1 hematuria. CONCLUSIONS: Intravesical instillation of HMW-HA appears to be effective in the treatment of radiation-induced cystitis. Further comparative studies with longer follow-up are needed to confirm our preliminary results.
Subject(s)
Cystitis/drug therapy , Hyaluronic Acid/administration & dosage , Radiation Injuries/drug therapy , Administration, Intravesical , Aged , Female , France , Humans , Hyaluronic Acid/adverse effects , Male , Molecular Weight , Pilot Projects , Prospective Studies , Treatment OutcomeABSTRACT
PURPOSE: Ejaculatory dysfunction is the most common side effect related to surgical treatment of benign prostatic obstruction (BPO). Nowadays, modified surgical techniques and non-ablative techniques have emerged with the aim of preserving antegrade ejaculation. Our objective was to conduce a systematic review of the literature regarding efficacy on ejaculatory preservation of modified endoscopic surgical techniques, and mini-invasive non-ablatives techniques for BPO management. METHODS: A systematic review of the literature was carried out on the PubMed database using the following MESH terms: "Prostatic Hyperplasia/surgery" and "Ejaculation", in combination with the following keywords: "ejaculation preservation", "photoselective vaporization of the prostate", "photoselective vapo-enucleation of the prostate", "holmium laser enucleation of the prostate", "thulium laser", "prostatic artery embolization", "urolift", "rezum", and "aquablation". RESULTS: The ejaculation preservation rate of modified-TURP ranged from 66 to 91%. The ejaculation preservation rate of modified-prostate photo-vaporization ranged from 87 to 96%. The only high level of evidence studies available compared prostatic urethral lift (PUL) and aquablation versus regular TURP in prospective randomized-controlled trials. The ejaculation preservation rate of either PUL or aquablation compared to regular TURP was 100 and 90 versus 34%, respectively. CONCLUSIONS: Non-ablative therapies and modified endoscopic surgical techniques seemed to be reasonable options for patients eager to preserve their ejaculatory functions.
Subject(s)
Ejaculation , Prostatic Hyperplasia/surgery , Sexual Dysfunction, Physiological/prevention & control , Transurethral Resection of Prostate/adverse effects , Urinary Bladder Neck Obstruction/surgery , Urination Disorders/prevention & control , Ablation Techniques , Embolization, Therapeutic , Endoscopy , Humans , Laser Therapy , Lasers, Solid-State/therapeutic use , Male , Minimally Invasive Surgical Procedures , Prostate/blood supply , Prostate/surgery , Prostatic Hyperplasia/complications , Prostatic Hyperplasia/therapy , Prosthesis Implantation , Sexual Dysfunction, Physiological/etiology , Steam , Urinary Bladder Neck Obstruction/etiology , Urinary Bladder Neck Obstruction/therapy , Urination Disorders/etiologyABSTRACT
OBJECTIVE: To explore efficacy and safety of Botulinum Neurotoxin Type A (BoNT-A) prostatic injection in patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperperplasia. MATERIALS AND METHODS: A phase 3 multicenter open-labeled study randomised patients to receive BoNT-A prostatic injection or optimized medical therapy. BoNT-A injection consisted in trans-rectal injections of 200 UI in the transitional zone of the prostate. Optimal medical therapy consisted in oral medication with any drug patented for LUTS. One month (M1) after randomisation patients in the BoNT-A group were asked to stop any medical therapy related to LUTS. The main judgment criterion was the IPSS score at M4. Per-protocol analysis was performed with a non-inferiority hypothesis (ΔIPSS < 3). RESULTS: 127 patients were randomised to BoNT-A (n = 64) or medical therapy (n = 63). At randomisation mean IPSS was 16.9 ± 7.2 in the BoNT-A group vs 15.7 ± 7.3 in control. In the BoNT-A group, 44 patients (73.3%) could interrupt medical therapy for LUTS from M1 to M4. At M4, mean IPSS score was 12.0 ± 6.7 in the BoNT-A group vs 11.8 ± 6.9 in control. After adjustment for baseline IPSS, delta IPSS between groups was 0.01; 95% CI [- 2.14; 2.11] leading to accept the non-inferiority hypothesis. CONCLUSIONS: Four months after BoNT-A injection, most of the patients could interrupt LUTS-related medical treatments. In these patients, IPSS improvement was not inferior to optimized medical treatment, but the study design did not allow to conclude that this improvement was related with study drug rather than with sustained placebo effect. TRIAL REGISTRATION: NCT01275521.
Subject(s)
Botulinum Toxins, Type A/administration & dosage , Lower Urinary Tract Symptoms/drug therapy , Neuromuscular Agents/administration & dosage , Prostatic Hyperplasia/complications , Aged , Aged, 80 and over , France , Humans , Injections, Intralesional , Lower Urinary Tract Symptoms/etiology , Male , Middle Aged , Treatment Outcome , Withholding TreatmentABSTRACT
OBJECTIVES: To describe the step-by-step learning curve of the holmium laser enucleation of the prostate (HoLEP) surgical technique. SUBJECTS/PATIENTS AND METHODS: A prospective, multicentre observational study was conducted, involving surgeons experienced in transurethral resection of the prostate and open prostatectomy but never having performed HoLEP. The main judgment criterion was the ability of the surgeon to perform four consecutive successful procedures, defined by the following: complete enucleation and morcellation within <90 min, without any conversion to standard transurethral resection of the prostate (TURP), with acceptable stress, and with acceptable difficulty (evaluated by Likert scales). Each surgeon included 20 consecutive cases. RESULTS: Of nine centres, three abandoned HoLEP before the end of the study due to complications, and one was excluded for treating patients off protocol. Only one centre achieved the main judgment criterion of four consecutive successful HoLEP procedures. Overall, the procedures were successfully performed in 43.6% of cases. Reasons for unsuccessful procedures were mainly operative time >90 min (n = 51), followed by conversion to TURP (n = 14), incomplete morcellation (n = 8), significant stress (n = 9), or difficulty (n = 14) during HoLEP. Ignoring operating time, 64% of procedures were successful and four out of five centres did four consecutive successful cases. Of the five centres that completed the study, four chose to continue HoLEP. CONCLUSION: Even in a prospective training structure, HoLEP has a steep learning curve exceeding 20 cases, with almost half of our centres choosing to abandon or not to continue with the technique. Operating time and difficulty of the enucleation seem the most important problems for a beginner. A more intensely mentored and structured mentorship programme might allow safer adoption of the procedure.
Subject(s)
Education, Medical, Continuing , Laser Therapy , Learning Curve , Prostatic Diseases/surgery , Adult , Aged , Humans , Lasers, Solid-State , Male , Middle Aged , Operative Time , Prospective Studies , Transurethral Resection of Prostate/educationABSTRACT
INTRODUCTION: Treatment of lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH) has shifted over the last decades, with medical therapy becoming the primary treatment modality while surgery is being reserved mostly to patients who are not responding to medical treatment or presenting with complications from BPH. Here, we aim to to discuss the optimal timing of surgical management of LUTS/BPH. MATERIALS AND METHODS: A literature search was conducted on Pub-Med/MEDLINE database to identify reports published from January 1990 until January 2022 by combining the following MeSH terms: "Lower Urinary Tract Symptoms"; "Prostatic Hyperplasia"; "Prostatic Hyperplasia/therapy"; "Prostatic Hyperplasia/complications"; "Treatment Outcome"; "Time-to-Treatment". Evidence supporting or not early surgical treatment of BPH was examined and reported in a pros and cons form. RESULTS: The "pro early surgery" highlighted the superior efficacy and cost-effectiveness of surgery over medical treatment for BPH, as well as the possibility of worse postoperative outcomes for delayed surgical treatment. The "con early surgery" considered that medical therapy is efficient in well-selected patients and can avoid the serious risks inherent to surgical treatment of BPH including important sexual side effects. CONCLUSIONS: Clinical trials comparing the outcomes for prolonged medical therapy versus early surgical treatment could determine which approach is more beneficial in the long-term in context of the aging population. Until then, both approaches have their advantages and patients should be involved in the treatment decision.
Subject(s)
Lower Urinary Tract Symptoms , Prostatic Hyperplasia , Time-to-Treatment , Prostatic Hyperplasia/surgery , Humans , Male , Lower Urinary Tract Symptoms/surgery , Lower Urinary Tract Symptoms/etiology , Prostatectomy/methods , Prostatectomy/adverse effects , Time FactorsABSTRACT
PURPOSE: To report the efficacy and safety of water vapor thermal therapy to achieve catheter removal in frail patients with refractory acute urinary retention. METHODS: Data from consecutive frail patients with indwelling urinary catheter undergoing the Rezum™ therapy (Boston Scientific Corporation, Marlborough, MA) at a single center between October 2017 and June 2021 were prospectively collected. The included patients were deemed unfit or at high risk of complications for conventional benign prostatic hyperplasia (BPH) surgery. Prostate volumes up to 120 mL were considered eligible. The primary endpoint was successful cessation of catheter dependency, assessed postoperatively and up to 1 year of follow-up. RESULTS: A total of 24 men met our inclusion criteria. The median age, Charlson comorbidity index, and duration of preoperative catheterization were 77 years (IQR 67-86), 6 (IQR 3-7), and 113 days (IQR 87-159), respectively. Two cases (8.3%) of postoperative complications were recorded (Clavien II and Clavien IIIa). After a median postoperative catheterization time of 21 days (IQR 11-32), all patients regained spontaneous voiding. During follow-up, two patients died and a total of 22 patients completed the 1 year follow-up. All patients maintained spontaneous voiding without recurrence of urinary retention. No surgical retreatment was performed. In terms of pharmacological management, 22/24 patients (91.7%) had a BPH medication pre-Rezum™; this decreased to 8/22 patients (36.3%) post-Rezum™ (p < 0.001). CONCLUSIONS: In this single-institution, prospective, and observational study, water vapor thermal therapy was found to be effective and safe in restoring successful spontaneous voiding in a cohort of elderly and frail patients.
Subject(s)
Prostatic Hyperplasia , Urinary Retention , Male , Aged , Humans , Aged, 80 and over , Urinary Retention/therapy , Urinary Retention/complications , Catheters, Indwelling/adverse effects , Prostatic Hyperplasia/complications , Prostatic Hyperplasia/surgery , Steam , Urinary Catheters/adverse effects , Urinary Catheterization , Prospective Studies , Frail Elderly , Treatment OutcomeABSTRACT
CONTEXT: Office-based treatments are increasingly offered as an optional step to replace medical treatment or delay surgery for male lower urinary tract symptoms (LUTS). Nevertheless, little is known regarding the risks of retreatment. OBJECTIVE: To systematically evaluate the current evidence regarding retreatment rates after water vapor thermal therapy (WVTT), prostatic urethral lift (PUL), and temporarily implanted nitinol device (iTIND) procedures. EVIDENCE ACQUISITION: A literature search was conducted up to June 2022 using the PubMed/Medline, Embase, and Web of Science databases. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed to identify eligible studies. The primary outcomes were the rates of pharmacologic and surgical retreatment during follow-up. EVIDENCE SYNTHESIS: A total of 36 studies including 6380 patients met our inclusion criteria. Surgical and minimally invasive retreatment rates were generally well reported in the studies included and reached up to 5% after 3 yr of follow-up for iTIND, and up to 4% for WVTT and 13% for PUL after 5 yr of follow-up. The types and rates of pharmacologic retreatment are poorly reported in the literature, with the latter reaching up to 7% after 3 yr of follow-up for iTIND, and up to 11% after 5 yr of follow-up for WVTT and PUL. The main limitations of our review are the unclear to high risk of bias in most of the studies included and the lack of long-term (>5 yr) data on retreatment risks. CONCLUSIONS: Our results highlight the low retreatment rates at mid-term follow-up after office-based treatments for LUTS, supporting the development of these strategies as an intermediate step between BPH medication and conventional surgery. Pending more robust data with longer follow-up, these results should be used to improve patient information and facilitate shared decision-making. PATIENT SUMMARY: Our review highlights the low risk of mid-term retreatment after office-based treatments for benign enlargement of the prostate that is affecting urinary function. For well-selected patients, these results support the increasing use of office-based treatment as an intermediate option before conventional surgery.
Subject(s)
Lower Urinary Tract Symptoms , Prostatic Hyperplasia , Humans , Male , Prostatic Hyperplasia/complications , Prostatic Hyperplasia/drug therapy , Prostatic Hyperplasia/surgery , Prostate/surgery , Retreatment , Urethra/surgery , Prostheses and Implants , Lower Urinary Tract Symptoms/surgeryABSTRACT
BACKGROUND: Although sacral neuromodulation (SNM) for overactive bladder (OAB) is an established therapy, there is a lack of high-quality, long-term data on real-life practice. OBJECTIVE: To report on real-life therapeutic effectiveness, quality of life (QoL), disease severity, and safety as well as patient-reported symptom bother after approximately 5 yr of follow-up. DESIGN, SETTING, AND PARTICIPANTS: A total of 291 OAB patients were enrolled at 25 French sites according to local standard of care. Sacral neuromOdUlation with InterStim therapy for intractable lower uriNary tract DySfunctions (SOUNDS) enrolled both de novo and replacement patients, and a total of 229 patients were permanently implanted. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Over the course of the study, patients were followed up six times with two follow-ups in the year after implantation and annually thereafter. Of the patients, 154 completed the final follow-up after a mean of 57.7 ± 3.9 mo. RESULTS AND LIMITATIONS: The mean number of daily leaks in urinary urge incontinence (UI) patients was reduced from 4.4 ± 3.3 at baseline to 1.8 ± 2.6 after 5 yr in de novo and from 5.4 ± 4.9 to 2.2 ± 3.0 in replacement patients (both p < 0.001). Likewise, the number of voids in urinary frequency patients was reduced compared with baseline (de novo: reduced from 12.6 ± 4.0 [baseline] to 9.6 ± 4.3 [5 yr]; replacements: reduced from 11.5 ± 4.3 [baseline] to 9.2 ± 3.1 [5 yr]; both p < 0.05). Complete continence rates after 5 yr were 44% (25/57) in de novo and 33% (5/15) in replacement UI patients, and 68% (39/57) and 67% (10/15) of UI patients were categorized as therapy responders by showing a >50% improvement in leaks. Disease severity (Urinary Symptom Profile domain 2), Numeric Rating Scale-based symptom bother, and disease-specific QoL (Ditrovie) improved significantly in both groups at all visits (p < 0.001). Adverse events related to device or procedure occurred in 51% (140/274) of patients, with 66% (152/229) of the events being classified as minor (Clavien-Dindo grade I and II). Surgical revisions were reported in 39% (89/229), which include permanent explants in 15% (34/229) of patients. CONCLUSIONS: SOUNDS demonstrates the sustained effectiveness and QoL improvements of SNM in OAB patients after 5 yr in real-world conditions while maintaining an acceptable safety profile consistent with literature. PATIENT SUMMARY: This study confirmed that French overactive bladder patients had a sustained symptom and bother reduction, and improvements in quality of life up to 5 yr after sacral neuromodulation device implantation.
Subject(s)
Electric Stimulation Therapy , Urinary Bladder, Overactive , Humans , Quality of Life , Prospective Studies , Treatment Outcome , Electric Stimulation Therapy/adverse effects , Electric Stimulation Therapy/methods , Urinary Incontinence, Urge/therapy , Urinary Incontinence, Urge/etiologyABSTRACT
UNLABELLED: Study Type - Therapy (multi-centre cohort). Level of Evidence 2b. OBJECTIVE: To evaluate the early functional outcomes of transurethral plasma vaporization of the prostate (TUVis) in a multicentre study. PATIENTS AND METHODS: A prospective multicentre observational study was conducted in eight urology departments. The inclusion criterion was benign prostatic hyperplasia (BPH) requiring surgical treatment. Patients on anti-coagulant therapy were not excluded. The TUVis procedure was performed according to a classic transurethral resection of the prostate (TURP) scheme following the manufacturer's recommendations. We evaluated subjective functional outcome using self-questionnaires (International Prostate Symptom Score [IPSS] and five-item International Index of Erectile Function [IIEF-5]) and objective criteria (prostate volume, prostate-specific antigen [PSA], uroflowmetry, post residual volume) at baseline and at 1- and 3-month follow-ups. All types of complications were systematically recorded. RESULTS: Despite 52% of patients receiving anticoagulant therapy before surgery, we reported only 3% with haemorrhagic complications, no blood transfusion, a mean catheterization time of 44 h and a mean postoperative stay of 2.9 nights. No significant change in irrigation time, catheter time or hospital stay was observed in patients with or without anticoagulant therapy. The IPSS and bother scores significantly decreased after the 3-month follow-up (57% and 59%, respectively), but the average remaining prostate volume was 29 cc and the tissue ablation rate was only 0.5 cc/min. Three major complications occurred, consisting of two urinary fistulas and one partial bladder coagulation. CONCLUSIONS: The TUVis procedure has a proven fast postoperative recovery time, good short-term functional outcome and good haemostatic efficiency. However, the tissue ablation rate was lower than expected and we encountered three major complications, the mechanisms of which remain unclear. Considering the high energy level required to create the plasma effect, the generator, cable and resectoscope must be carefully checked before each procedure.
Subject(s)
Electrocoagulation/methods , Prostatic Hyperplasia/surgery , Transurethral Resection of Prostate/methods , Aged , Aged, 80 and over , Cutaneous Fistula/etiology , Humans , Length of Stay , Lower Urinary Tract Symptoms/etiology , Male , Middle Aged , Postoperative Complications/etiology , Prospective Studies , Treatment Outcome , Urethral Diseases/etiology , Urinary Fistula/etiologyABSTRACT
BACKGROUND: SOUNDS strengthens the evidence basis of sacral neuromodulation (SNM) for overactive bladder (OAB) through real-world data. OBJECTIVE: To analyze diary-based effectiveness, quality of life (QoL), disease severity, symptom bother, and safety data for SNM with the InterStim system up to 3 yr after implantation. DESIGN, SETTING, AND PARTICIPANTS: Twenty-five representative French sites enrolled 291 patients with OAB followed according to the local standard of care. Overall, 229 patients received a de novo or replacement InterStim implant and had four follow-up visits, two within the first yr and annually thereafter. A total of 190 patients completed the fourth follow-up visit after a mean of 33.7 ± 3.7 mo. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The effectiveness outcomes measured were changes in daily voids and leaks and the therapy responder rates. Other outcomes included validated QoL data (Ditrovie and EuroQol 5-dimension 5-level questionnaires), disease severity (Urinary Symptom Profile [USP]), symptom bother rated using a numeric rating scale (NRS), and safety data. Follow-up data were compared to baseline results using the Wilcoxon signed-rank test. RESULTS AND LIMITATIONS: Average daily voids and leaks were significantly reduced at all time points up to 3 yr after implantation (p < 0.05) except for voids at 21 mo in the group receiving a replacement device. The therapeutic response for urinary urge incontinence at the fourth follow-up was 72% for the de novo group and 86% for the replacement group. Disease-specific QoL (Ditrovie), OAB-specific symptom severity (USP domain 2), and NRS-rated disease bother were significantly improved at all visits (p < 0.001). Device- or procedure-related adverse events occurred in 49% of patients, with 68% of the events classified as minor (Clavien-Dindo grade I or II). Surgical revisions were performed in 33% of patients, including permanent removal in 13%, over a mean exposure time of 44.4 ± 15.3 mo. CONCLUSIONS: This study confirms the safety and effectiveness of SNM for OAB and improvements in QoL and disease bother in real life. PATIENT SUMMARY: Our study in French patients with overactive bladder showed that disease symptoms and bother were significantly reduced and quality of life was significantly improved over a study duration of approximately 3 yr after implantation of a device to stimulate nerves that control the bladder. This trial is registered at ClinicalTrials.gov as NCT02186041.
Subject(s)
Electric Stimulation Therapy , Urinary Bladder, Overactive , Humans , Urinary Bladder, Overactive/diagnosis , Quality of Life , Prospective Studies , Electric Stimulation Therapy/adverse effects , Electric Stimulation Therapy/methods , Treatment OutcomeABSTRACT
OBJECTIVE: ⢠To evaluate the impact of urisheaths vs absorbent products (APs) on quality of life (QoL) in men with moderate to severe urinary incontinence (UI). PATIENTS AND METHODS: ⢠A randomized, controlled, crossover trial in 61 outpatient adult men with stable, moderate to severe UI, with no concomitant faecal incontinence, was conducted from June 2007 to February 2009 in 14 urology centres. ⢠Participants tested Conveen Optima urisheaths (Coloplast, Humlebaek, Denmark) with collecting bags and their usual AP in random order for 2 weeks each. ⢠The impact of each on QoL was measured using the King's Health Questionnaire (KHQ) and the short form-12 acute questionnaire, and each patient's preference was recorded. ⢠A 10-item patient questionnaire was also used to assess the product main advantages on an 11-point scale (0: worst; 10: best). A 72-h leakage diary was used to record the number and severity of leaks and daily product consumption. Safety was measured as the number of local adverse events. RESULTS: ⢠All dimensions of the KHQ were scored lower with urisheaths, indicating an improvement in QoL. The greatest mean score reductions were in Limitations of Daily Activities (-10.24, P= 0.01) and Incontinence Impact (-7.05, P= 0.045). ⢠The majority (69%) of patients preferred Conveen Optima urisheaths to their usual AP (P = 0.002). ⢠Urisheaths scored significantly higher for all categories in the patient questionnaire (efficacy, self-image, odour management, discretion, skin integrity) except ease of use. ⢠Safety was considered to be good. CONCLUSIONS: ⢠Conveen Optima urisheaths showed a positive impact on QoL (according to the KHQ results) in moderate to severe incontinent men, who were long-term users of APs, and participants largely preferred urisheaths. ⢠Conveen Optima urisheaths should be recommended to incontinent men in preference to APs.
Subject(s)
Incontinence Pads , Patient Preference , Quality of Life , Urinary Incontinence , Urology/instrumentation , Aged , Epidemiologic Methods , Humans , Male , Middle AgedABSTRACT
AIM: To assess the impact of oral anticoagulation (OA) on morbidity of transurethral resection of the prostate (TURP). OA included warfarin and platelet aggregation inhibitors (PAI). PATIENTS AND METHOD: Multicenter analysis of patients operated for symptomatic benign prostatic hyperplasia (BPH) by TURP. Patients under OA were compared to those with no OA. RESULTS: Out of 612 patients included in the analysis, 206 (33%) were on OA prior surgery (55 warfarin, 142 PAI, and 9 warfarin and PAI). No patient continued warfarin and clopidogrel during the operating period. Patients under OA were significantly older (75 vs. 71 yo, P < 0.001), had larger prostate volume (56 vs. 49 ml, P = 0.05), and had higher rate of bladder catheter prior surgery (26 vs. 17%, P = 0.02). At 3 months follow-up, patients in the OA group had a higher weight of resected tissue (24 vs. 21.7 g, P < 0.001), a longer duration of hospitalization (6.4 vs. 4.7 days P < 0.001), a higher rate of bladder clots (13 vs. 4.7%, P < 0.001), red cell transfusion (1.9 vs. 1.0%, P = 0.026), late hematuria (15.0 vs. 8.4%, P = 0.004), and thromboembolic events (2.4 vs. 0.7, P = 0.02). In multivariable analysis, OA status was the sole independent parameter associated with bladder clots (P = 0.004) and with late hematuria (P = 0.03). CONCLUSION: OA had a significant and independent impact on TURP outcome in terms of bleeding complications. This data could be used for treatment decision and for patient's information prior BPH surgery.
Subject(s)
Anticoagulants/administration & dosage , Hematuria/epidemiology , Thromboembolism/epidemiology , Transurethral Resection of Prostate/adverse effects , Administration, Oral , Adult , Aged , Aged, 80 and over , Erythrocyte Transfusion , Humans , Length of Stay , Male , Middle Aged , Morbidity , Platelet Aggregation Inhibitors/administration & dosage , Warfarin/administration & dosageABSTRACT
INTRODUCTION: To compare postoperative outcomes of patients on oral anticoagulation (OA) treated with transurethral plasma vaporization of the prostate in saline water (TUVis) and transurethral resection of the prostate (TURP). MATERIALS AND METHODS: Between January and December 2009, 111 patients on OA therapy were treated with either TURP or TUVis in eight centers. Types of OA and perioperative management were collected. Postoperative outcomes were statistically compared between the two groups. RESULTS: A total of 57 (51%) and 54 (49%) patients were treated with TURP and TUVis, respectively. Types of OA were not significantly different between the two groups, but bladder catheterization prior to surgery was more frequently observed in the TUVis group. Before surgery, 28 patients were treated with warfarin alone, 74 with a platelet aggregation inhibitor (PAI) alone, and 9 with a combination of both. PAI was withdrawn preoperatively in 50 patients. All treatments with warfarin were switched for heparin. Comparison of the two groups showed significantly less hemorrhagic complications after TUVis. Patients treated with TUVis experienced less bladder washouts (2% versus 18%, p = 0.008), less late hematuria (4% versus 19%, p = 0.02), and lower decrease of serum hemoglobin (mean decrease of 0.66 versus 1.47 g/dL, p = 0.02). Postoperative bladder catheterization and hospital stay were significantly shorter, whereas the rate of urinary retention was significantly higher. Three months after surgery, functional results were not significantly different between the two groups. CONCLUSIONS: In patients on OA, TUVis led to significantly less bleeding, as well as shorter bladder catheterization and hospital stay than TURP.
Subject(s)
Anticoagulants/administration & dosage , Cardiovascular Diseases/drug therapy , Hematuria/prevention & control , Laser Therapy/methods , Postoperative Hemorrhage/prevention & control , Prostatic Hyperplasia/surgery , Transurethral Resection of Prostate/methods , Administration, Oral , Aged , Aged, 80 and over , Cardiovascular Diseases/complications , Follow-Up Studies , Humans , Male , Middle Aged , Prostatic Hyperplasia/complications , Retrospective Studies , Treatment Outcome , Urinary Catheterization , VolatilizationABSTRACT
PURPOSE: This study aimed at reporting a head-to-head comparison between water vapor thermal therapy using the Rezum™ system and prostatic urethral lift using the Urolift™ system in men with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: From December 2017 to November 2019, consecutive patients who underwent Rezum™ and Urolift™ procedures in two urology centers have been retrospectively considered. Only patients with a prostate size less than 80 mL were included. We used the PSM method to adjust baseline differences between both groups. The co-primary endpoint included the change in International Prostate Symptom Score (IPSS) and IPSS- quality of life (QoL) from baseline to 12 months. RESULTS: A total of 61 (52.1%) and 56 (47.9%) patients underwent Rezum™ and Urolift™ procedures, respectively. After PSM adjustment, 24 patients were included in both groups. No serious adverse events occurred (> Clavien II) in both groups. At 12 months, higher IPSS improvement was observed in the Rezum™ group (median:4 [IQR 3-5]) than in the Urolift™ group (median:8 [IQR 7-12]), without statistical difference (p = 0.08). The improvement in term of QoL at 12 m was similar (p = 0.43). The retreatment rates were 25% (Urolift™) and 8.3% (Rezum™), p = 0.24. Erection and ejaculatory function scores did not change significantly in either treatment group. Results in the full cohort showed that Rezum™ appeared to deliver greater improvements for IPSS and IPSS-QoL (p < 0.001 and p = 0.006, respectively) and lower reintervention rate (p = 0.006) than Urolift™. CONCLUSIONS: In this small retrospective study, our results indicate that both Rezum™ and Urolift™ provide a clinically significant improvement in symptoms and QoL, although some of these improvements were greater in the Rezum™ arm. Future studies are needed to definitively assess which treatment would be best suited for each patient.
Subject(s)
Ablation Techniques/methods , Lower Urinary Tract Symptoms/surgery , Prostatic Hyperplasia/surgery , Steam , Urethra/surgery , Aged , Humans , Hyperthermia, Induced , Lower Urinary Tract Symptoms/etiology , Male , Middle Aged , Prostatic Hyperplasia/complications , Quality of Life , Retrospective Studies , Treatment Outcome , Urologic Surgical Procedures/methodsABSTRACT
BACKGROUND: Real-world data that support the use of sacral neuromodulation (SNM) for lower urinary tract dysfunctions are of continued interest. OBJECTIVE: To evaluate the effectiveness, quality of life (QoL), patient-reported outcomes (PROs), and safety of SNM with the InterStim™ system in real life during 1-yr postimplant. DESIGN, SETTING, AND PARTICIPANTS: This is a prospective, multicenter, observational study at 25 representative public and private French sites. Eligible patients received SNM therapy for overactive bladder (OAB) and non-obstructive urinary retention based on local standard of care. Overall, 320 patients were enrolled; 247 received permanent implant or replacement; 204 implanted patients completed second follow-up after mean of 10.0±3.8 mo. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Effectiveness outcomes were change in voids, leaks, and catheterizations/day. Other outcomes included validated QoL and disease severity scores as well as PROs and adverse event data. Outcomes at follow-ups were compared with baseline using the Wilcoxon signed-rank test. RESULTS AND LIMITATIONS: Voids in urinary frequency (UF) and leaks/day in urinary urge incontinence (UI) patients were significantly reduced after 10 mo in both de novo (mean baseline voids/day UF de novo: 12.7 vs 8.6 after 10 mo; p<0.001; mean baseline leaks/day UI de novo: 4.3 vs 1.1 after 10 mo; p<0.001) and replacement patients (mean baseline voids/day UF replacement: 11.5 vs 7.9 after 10 mo; p<0.001; mean baseline leaks/day UI replacement: 5.4 vs 1.0 after 10 mo; p<0.001). Disease bother, Urinary Symptom Profile score, and Ditrovie questionnaire score were also significantly improved. Revisions postimplant occurred in 20% of patients including in 9% due to permanent explantation during a mean exposure time of 24.3 mo. CONCLUSIONS: Through a real-life study, SOUNDS (Sacral neuromOdUlation with InterStim™ therapy for intractable lower uriNary tract DySfunctions) confirms the clinical effectiveness, safety, and positive effect of SNM on QoL and PROs for the treatment of OAB patients. PATIENT SUMMARY: These analyses on French patients who received sacral neuromodulation (SNM) for retention or OAB during a 10-mo period showed that SNM improved OAB symptoms, quality of life, and reduced disease bother. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02186041.
Subject(s)
Electric Stimulation Therapy , Urinary Bladder, Overactive , Electric Stimulation Therapy/adverse effects , Electric Stimulation Therapy/methods , Humans , Patient Reported Outcome Measures , Prospective Studies , Quality of Life , Treatment Outcome , Urinary Incontinence, Urge/etiology , Urinary Incontinence, Urge/therapyABSTRACT
BACKGROUND/AIMS: There are only a few surveys on the prevalence of lower urinary tract symptoms (LUTS) among the general population. The aim of this survey was to assess the prevalence of LUTS and their impact on discomfort in men. METHODS: A questionnaire was mailed to 3,877 men aged 50-80 years, which included questions on their medical history, demographic and sociological status, and also the International Prostate Symptom Score (IPSS) with additional questions on discomfort related to urinary symptoms. RESULTS: The response rate was 81.5%. Prevalence of mild and severe IPSS was 89.2%. Specific bother for each urinary symptom depended on symptom frequency: urgency, frequency, weak stream, nocturia, incomplete emptying, intermittency and straining 1 time out of 5 were responsible for discomfort in respectively 4.9, 6.1, 7.1, 7.5, 8.7 and 9.9%; the same symptoms more than half of the time were responsible for discomfort in respectively 32.8, 38, 45.3, 45.6, 53.2 and 58.7%. Urgency was much more deeply implicated in discomfort than frequency of nocturia. CONCLUSIONS: Urinary symptoms in men are very common. Nocturia is the most frequent but has a low impact on discomfort. Urgency has a higher impact on discomfort and should therefore be considered in treatment decision-making.
Subject(s)
Prostatic Hyperplasia/epidemiology , Quality of Life , Urination Disorders/epidemiology , Age Distribution , Age Factors , Aged , Aged, 80 and over , France/epidemiology , Health Surveys , Humans , Male , Middle Aged , Prevalence , Prostatic Hyperplasia/complications , Surveys and Questionnaires , Urination Disorders/etiologyABSTRACT
We assessed the therapeutic efficacy and safety of laser prostatectomy (LP) for treating benign prostatic hyperplasia (BPH) in patients on oral anticoagulation. We systematically reviewed previous reports, using the Pubmed database and bibliographies of retrieved articles and reviews. The oral anticoagulation included coumarin derivatives and platelet-aggregation inhibitors (PAI). Previous studies do not allow the establishment of definitive conclusions for managing patients on oral anticoagulation and who require BPH surgery. No randomized studies are available. Nevertheless, compared to transurethral resection of the prostate (TURP), LP seems to decrease the risk of haemorrhage in patients taking PAI or coumarin derivatives. Therefore, LP is a useful alternative to TURP for managing patients on oral anticoagulation, and could be proposed as the first intention for those patients. Continuing PAI during the procedure is feasible. A replacement of coumarin derivatives by low molecular weight heparin is preferable. No conclusion can be reached on the preferred type of laser technique to treat these patients, but data on laser enucleation is much less abundant and conclusive than that on laser vaporization.