[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prostatectomy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prostatectomy":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,45,74,107,118,138,162,191,229,256],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100053817","sacral-neuromodulation-for-male-overactive-bladder-moab-100053817",false,"NCT06511141","Sacral Neuromodulation for Male Overactive Bladder (MOAB)","Sacral Neuromodulation for Male Overactive Bladder","Key Inclusion Criteria:\n\n1. Participants aged ≥ 18 years at the time of enrollment\n2. Able to complete bladder diaries and patient questionnaires\n3. Primary diagnosis of OAB (urinary urgency incontinence (UUI) or urinary frequency (UF)).\n4. Willing and capable to provide written informed consent and agrees to comply with specified evaluations at clinical investigational sites and attend all follow-up assessments for up to 1 year\n\nKey Exclusion Criteria:\n\n1. Any patient that is not a suitable candidate per investigator discretion\n2. Recent prostate therapy or procedure within the last 6 months at the time of enrollment\n3. Any neurological condition that could interfere with normal bladder function, including stroke, epilepsy, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia)\n4. Previously implanted with a sacral neuromodulation device, including inactive SNM devices\n5. Any prior treatment with an Implantable Tibial Nerve Stimulation (ITNS)\n6. Positive response to Percutaneous Tibial Nerve Stimulation (PTNS) within the last 3 months at the time of enrollment\n7. Underwent an external trial with any sacral neuromodulation device and was deemed a non-responder by a physician\n8. Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study objectives at the discretion of the participating physician.\n9. Uncontrolled diabetes\n10. Known allergic reactions to components of the Axonics SNM System, including titanium, zirconia, polyurethane, epoxy, or silicone","MALE","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"NA","To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.",[26,27,28,29,30,31],"Overactive Bladder","Urinary Urgency Incontinence","Benign Prostatic Hyperplasia","Prostate Cancer","Prostatectomy","Urinary Frequency","RECRUITING","2026-07-10",{"date":35,"type":36},"2026-07-13","ACTUAL",{"date":38,"type":36},"2024-10-22",{"date":40,"type":20},"2028-12",{"name":42,"class":43},"Axonics, Inc.","INDUSTRY",21,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100537147","phase-3-prostate-iq-parallel-randomized-study-of-personalized-apalutamide-treatment-and-evaluation-to-improve-quality-of-life-in-post-operative-radiation-with-androgen-axis-suppression-a-phase-iii-multi-center-study-for-men-with-detectable-psa-after-prostatectomy-for-prostate-cancer-100537147","NCT06274047","PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer.","Inclusion Criteria:\n\n1. Histologically confirmed prostate cancer.\n2. PSA ≥ 0.1 after radical prostatectomy.\n3. Candidate for salvage radiation and ADT treatment, as determined by treating physician.\n4. Age \\>18 at the time of consent.\n5. ECOG Performance Status ≤ 2.\n6. Demonstrate adequate organ function as defined in the table below. All screening labs to be obtained within 90 days of registration.\n\n   System Laboratory Value\n\n   Hematological:\n\n   Platelet count (plt) = ≥ 100,000\u002FµL\n\n   Hemoglobin (Hgb) = ≥ 9 g\u002FdL\n\n   Renal:\n\n   eGFR = ≥ 30 mL\u002Fmin using MDRD Formula\n\n   Hepatic and Other:\n\n   Bilirubin2 = ≤1.5 x upper limit of normal (ULN) Aspartate aminotransferase (AST) = ≤ 2.5 x ULN Alanine aminotransferase (ALT) = ≤ 2.5 x ULN Serum Albumin = \\> 3.0 g\u002FdL Serum potassium = ≥ 3.5 mmol\u002FL 2In subjects with Gilbert's syndrome, if total bilirubin is \\>1.5 x ULN, measure direct and indirect bilirubin; if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible.\n7. Ability to understand and comply with study procedures for the entire length of the study as determined by the site investigator or protocol designee.\n8. Ability to understand English or Spanish language as determined by the site investigator or protocol designee. Since the primary outcome is a questionnaire available in English and Spanish.\n9. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. Participants must have the ability to understand and willingness to sign the written informed consent document.\n\nExclusion Criteria:\n\n1. Use of post-prostatectomy testosterone suppression prior to registration (use of GnRH agonist or antagonist, with or without an anti-androgen). However, participants with testosterone recovery after post-prostatectomy testosterone suppression are eligible (testosterone recovery defined as total testosterone \\> 190 ng\u002FdL) regardless of how long their testosterone was suppressed.\n2. Use of testosterone suppression prior to prostatectomy if the ArteraAI Prostate Test (Post-RP) is required to risk stratify patients (those patients with PSA ≤0.5 and no evidence of nodal involvement require ArteraAI Prostate Test (Post-RP) to stratify).\n3. Confirmed extrapelvic or bone disease based on conventional imaging\n4. History of any of the following:\n\n   * Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year prior to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy).\n   * Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization. Any condition that in the opinion of the investigator, would preclude participation in this study.\n5. Current evidence of any of the following:\n\n   * Uncontrolled hypertension (consistently \\>160 systolic or \\>100 diastolic)\n   * Gastrointestinal disorder affecting absorption\n   * Active infection (eg, human immunodeficiency virus \\[HIV\\] or viral hepatitis).\n   * Any condition that in the opinion of the investigator, would preclude participation in this study.\n6. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\n8\\) Medications known to lower the seizure threshold (listed in section 5 below) must be discontinued or substituted 4 weeks prior to C1D1 of study treatment for participants on arms receiving apalutamide.",{"count":52,"type":20},120,[54],"PHASE3","1. Personalize treatment for prostate cancer based on how aggressive the disease is and\n2. Learn if apalutamide-based treatment can help to reduce fatigue and other side effects of treatment in participants who are being treated with radiation therapy for prostate cancer, as compared to standard therapy.",[57,30,29],"Androgen Axis Suppression",[59,60,61,62],"Prostate","Salvage Radiation","ADT","Quality of Life","2026-06-24",{"date":65,"type":36},"2026-06-26",{"date":67,"type":36},"2024-09-10",{"date":69,"type":20},"2029-06-30",{"name":71,"class":72},"M.D. Anderson Cancer Center","OTHER",5,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":4,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100644060","comparing-two-training-methods-for-learning-robot-assisted-radical-prostatectomy-100644060","NCT07669974","Comparing Two Training Methods for Learning Robot-Assisted Radical Prostatectomy","A Randomized Non-Inferiority Trial Comparing Two Training Modalities for Achieving Proficiency in Robot-Assisted Radical Prostatectomy","Inclusion Criteria:\n\n* Enrollment in the CC-ERUS training course or participants attending the same robotic RARP training course at ORSI Academy outside the formal CC-ERUS curriculum at ORSI Academy during the study period\n* Willingness and ability to provide informed consent for participation in the study\n\nExclusion Criteria:\n\n* Decline or inability to provide informed consent\n* Incomplete participation in the on-site training course preventing assessment on Day 5",true,"ALL",{"count":84,"type":20},56,[23],"This randomized non-inferiority study evaluates whether a robot-assisted radical prostatectomy (RARP) training pathway incorporating the IMRA Surgical Prostatectomy Class V Hydrogel Model is as effective as the current standard training pathway in achieving surgical proficiency.\n\nParticipants enrolled in a standardized robotic surgery training course will be randomly assigned to one of two training pathways that differ only in the training model used during one phase of the course. All participants will subsequently undergo assessment during human cadaver training.\n\nThe primary outcome is the proportion of participants who achieve predefined proficiency criteria during the final assessment. Secondary outcomes include technical performance scores, technical errors, self-reported confidence, perceived readiness to perform robot-assisted radical prostatectomy, and feasibility of implementing a synthetic model-based training pathway.\n\nThe study aims to determine whether a high-fidelity hydrogel model can provide training outcomes comparable to those achieved with biological models, supporting more ethical, scalable, and standardized robotic surgery training.",[88,30],"Robot-Assisted Radical Prostatectomy Training",[90,91,92,93,94,95,96],"Robot-Assisted Radical Prostatectomy","Robotic Surgery Training","Surgical Education","Proficiency-Based Progression Methodology","Hydrogel Model","Non-Inferiority Trial","Surgical Simulation","2026-06-22",{"date":99,"type":36},"2026-06-25",{"date":101,"type":20},"2026-06-15",{"date":103,"type":20},"2027-06-15",{"name":105,"class":72},"Orsi Academy",1,{"id":108,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":21,"phases":110,"briefSummary":24,"conditions":111,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":114,"completionDateStruct":115,"leadSponsor":116,"locationsCount":117},"100555365",{"count":19,"type":20},[23],[26,27,28,29,30,31],"2026-06-11",{"date":101,"type":36},{"date":38,"type":36},{"date":40,"type":20},{"name":42,"class":43},20,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":21,"phases":127,"briefSummary":128,"conditions":129,"keywords":130,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":135,"leadSponsor":136,"locationsCount":106},"100619726","a-comparison-of-radical-prostatectomy-and-precision-prostatectomy-in-low--and-intermediate-risk-prostate-cancers-100619726","NCT07348367","A Comparison of Radical Prostatectomy and Precision Prostatectomy in Low- and Intermediate-risk Prostate Cancers.","A Randomized Comparison of Radical Prostatectomy and Precision Prostatectomy in Low- and Intermediate-risk Prostate Cancers.","Inclusion Criteria:\n\n* Prostate cancer patients receiving treatment at Henry Ford Health from the investigator or co-investigator who opt for surgery.\n* Prostate-specific antigen (PSA) ≤20 ng\u002FmL\n* Clinical stage ≤cT2\n* Dominant unilateral lesion with Gleason ≤4+3 on biopsy\n* No Gleason ≥4 contralaterally\n* Preoperative SHIM score ≥17 (with or without phosphodiesterase-5 inhibitor use)\n\nExclusion Criteria:\n\n* • Androgen deprivation therapy within 6 months.\n\n  * Nodal positive disease\n  * Metastatic disease\n  * Prior prostate cancer therapy (e.g., radiation, HIFU).\n  * Significant comorbidities precluding surgery or life expectancy \\\u003C5 years as defined by the Prostate Cancer Comorbidity Index \\[5\\].\n  * Any previous cancer diagnosis.",{"count":126,"type":20},160,[23],"Prostate cancer (PCa) management for low- and intermediate-risk patients often involves radical prostatectomy (RP), which achieves oncologic control but is associated with significant functional impairments, such as erectile dysfunction (50-70%) and urinary incontinence (5-20%). To address these issues, precision prostatectomy (PP) has emerged as a novel surgical approach that preserves functional structures while removing \\>90% of prostate tissue.\n\nPP is thought to provide superior functional outcomes with acceptable oncological control by preserving the capsule, seminal vesicle (SV), and the surrounding neuronal nitric oxide synthase (nNOS) producing nerves on the side opposite to the dominant nodule while maximizing prostatic tissue removal. Early reports of PP demonstrate promising functional outcomes, with 90% of patients retaining sexual potency (Sexual Health Inventory for Men \\[SHIM\\] score ≥17) and 100% achieving continence (0-1 pads\u002Fday) by 12 months postoperatively. Importantly, PP only requires a different surgical technique, no more equipment, time, or labor is required. This means that there is no additional charge to patients, and it is covered the same by health insurance.\n\nWhile there are early results suggesting the superiority of PP, no randomized trials have yet to be performed. This study has two main aims: to demonstrate superiority of PP in terms of functional recovery while also establishing non-inferiority in oncologic outcomes compared to RP. This dual objective reflects the potential of PP to improve quality of life without compromising cancer control.\n\nEligible patients will be randomized to either RP, which is the current standard of care, or PP using random blocked randomization using the Zelen design.\n\nThe outcomes of interest will be measured at 12 months post-surgery. Functional outcomes will be measured using SHIM scores at 12 months and the number of pads used per day. Meanwhile, oncological outcomes will be measured by whether patients have received secondary prostate cancer treatment at 12 months post-surgery. These items are collected as part of standard of care of all patients 12 months after prostatectomy. RP and PP patients' sexual function recovery (SHIM ≥17 vs SHIM \\\u003C 17), as well as the proportion reaching continence (≤1 pad per day, \\> 1 pad per day) will be compared.\n\nRP has been shown to be effective in terms of oncological outcomes, though it has also been shown to be related to incontinence and erectile dysfunction. Early results have suggested that PP is superior in terms of functional outcomes while being as good as RP in terms of oncological outcomes, though no randomized trials have been conducted. This trial will address this literature gap and could lead to patients receiving care that is as effective ontologically and superior in terms of functional recovery as the current standard of care. This could lead to improved quality of life for patients after surgery. Considering that prostate cancer is the most common non-cutaneous carcinoma among men in the United States, this has the potential to help thousands of men per year by improving their quality of life without sacrificing oncological outcomes.",[30],[29,30],"2026-01-12",{"date":133,"type":36},"2026-01-16",{"date":131,"type":36},{"date":40,"type":20},{"name":137,"class":72},"Henry Ford Health System",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":147,"phases":4,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":106},"100591595","high-dose-rate-hdr-brachytherapy-salvage-after-prostatectomy-100591595","NCT06982469","High Dose Rate (HDR) Brachytherapy Salvage After Prostatectomy","Magnetic Resonance Imaging (MRI)\u002F Positron Emission Tomography (PET) Prostate-specific Membrane Antigen (PSMA) -Based Phase I-II Study of Salvage HDR Brachytherapy and External Beam Irradiation In Isolated Tumor Bed Relapses After Radical Prostatectomy","Inclusion Criteria:\n\n* Patients with increasing PSA after RP and clinical evidence of PET PSMA\u002FCholine+ and MRI+ isolated prostatic bed relapse (IPBR) that is implantable via transperineal route . The IPBR should be visible on TRUS imaging to allow proper implant placement.\n* Pathological confirmation is advised in all cases but it is not mandatory .\n* Brachytherapy MRI-based dosimetry\n* Patient written Informed Consent of the Institutional Review Board-approved protocol that discloses the investigational nature of the treatment as well as the available standard treatment options.\n\nExclusion Criteria:\n\n* Distant Metastases\n* Isolated nodal relapses\n* Prior Irradiation to the IPBR area\n* Multicentric IPBRs\n* Life expectancy of less than 5 years or inability to tolerate and comply with an HDR procedure","80 Years",{"count":117,"type":20},"OBSERVATIONAL","The goal of this observational study is to learn about the long-term effects of HDR Brachytherapy in men with isolated local relapses after radical prostatectomy. The main question it aims to answer is:\n\nDoes HDR Brachytherapy increase control rates and decreases complications compared with conventional External Irradiation?\n\nParticipants will be asked to receive HDR brachytherapy as part of their regular medical care for isolated local relapses after radical prostatectomy",[29,30,150,151,152],"Local Recurrence of Malignant Tumor of Prostate","Radiotherapy; Complications","Brachytherapy","2025-06-18",{"date":155,"type":36},"2025-06-19",{"date":157,"type":36},"2020-05-05",{"date":159,"type":20},"2030-05-01",{"name":161,"class":72},"Clinica Universidad de Navarra, Universidad de Navarra",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":16,"minAge":168,"maxAge":145,"enrollmentInfo":169,"targetDuration":4,"studyType":21,"phases":171,"briefSummary":172,"conditions":173,"keywords":176,"overallStatus":181,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":106},"100591484","the-effectiveness-of-telemedicine-monitoring-prehabilitation-in-prostate-cancer-patients-undergoing-radical-prostatectomy-100591484","NCT06981026","The Effectiveness of Telemedicine Monitoring Prehabilitation in Prostate Cancer Patients Undergoing Radical Prostatectomy","Inclusion criteria:\n\n* Biopsy-confirmed localized prostate cancer (ICD code C.61).\n* Indicated for radical prostatectomy, with or without pelvic lymphadenectomy (ePLND).\n* Not previously treated for prostate cancer, including radiation therapy to the pelvis, major pelvic surgery, or placement of a penile implant or artificial urinary sphincter.\n* No known urethral stricture or colostomy or chronic urinary catheterization.\n* No medical or current psychiatric disorders that precludes their participation in the study.\n* Status of the musculoskeletal system allowing physical exercise.\n* Urinary continent at baseline.\n* Has reliable internet and the skills\u002Fknowledge to use technologies use for the study.\n\nExclusion criteria:\n\n* Other malignant tumors, except for benign skin carcinoma.\n* Active treatment for other oncological diagnoses.\n* Presence of preoperative urinary incontinence.\n* Diagnosed mental or cognitive disorders.\n* Prior pelvic radiotherapy or hormone therapy for prostate cancer recurrence.\n* Severe musculoskeletal disorders preventing active exercise\n* Inability to use required technologies","40 Years",{"count":170,"type":20},200,[23],"The study titled \" The effectiveness of telemedicine monitoring prehabilitation in prostate cancer patients undergoing radical prostatectomy \" investigates the impact of a structured telemedicine-supported prehabilitation and rehabilitation program on reducing postoperative urinary incontinence in patients with localized prostate cancer. Radical prostatectomy, a common treatment for localized prostate cancer, is often associated with complications such as urinary incontinence, which significantly affects quality of life. This study aims to address this issue by enhancing patients' physical conditioning and adherence to pre- and postoperative rehabilitation through the use of wearable devices and remote physiotherapy consultations.",[30,174,175],"Prehabilitation","Telemedicine",[30,177,175,178,179,174,180],"Physiotherapy","eHealth","Oncology","Rehabilitation","NOT_YET_RECRUITING","2025-05-12",{"date":184,"type":36},"2025-05-20",{"date":186,"type":20},"2026-01-01",{"date":188,"type":20},"2028-09-30",{"name":190,"class":72},"University Hospital Olomouc",{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":198,"enrollmentInfo":199,"targetDuration":4,"studyType":21,"phases":201,"briefSummary":202,"conditions":203,"keywords":209,"overallStatus":181,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":106},"100586479","robotic-prostatectomy-artificial-intelligence-low-pressure-pain-ralp-trial-100586479","NCT06915909","Robotic Prostatectomy Artificial Intelligence Low Pressure Pain (RALP) Trial","Robotic Prostatectomy Artificial Intelligence Low Pressure Pain Study Trial - \"The Monitoring of Patients Outcomes Intraoperatively and Perioperatively Using the Airseal and Stryker Insufflator Undergoing Robotic Assisted Laparoscopic Prostatectomy at a Pressure and Stability of Pneumoperitoneum of 8 mmHg\"","Inclusion Criteria:\n\n* Patient indicated for non-emergent robotic Prostatectomy surgery\n* Patients (or appropriate legal representatives) able to provide written informed consent to participate in the study\n* Males, aged 18 to 75 years\n* Have no significant psychopathology that could limit the subject's ability to understand the procedure, comply with medical, surgical, and\u002For behavioural recommendations and office visits\n* Are American Society of Anaesthesiologists (ASA) Class I, II, or III);\n\nExclusion Criteria:\n\n* Patient participation in a different investigational clinical study within 90 days before screening and for the duration of this trial (unless previously approved by the investigator and Sponsor);\n* Patients requiring any surgical procedure in addition to Prostatectomy and or \u002F Pelvic Lymph node dissection\n* Previous pelvic surgery or previous malabsobtion or restrictive procedures performed for the treatment of obesity\n* Inability to provide informed consent\n* Unable or unwilling to attend follow-up visits and examinations\n* Uncontrolled hypertension (=\u002F\\>Systolic: 180 mmHg\u002FDiastolic: 120 mmHg) and\u002For diabetes mellitus (Blood sugar level: \\>200 mg\u002FdL)\n* Patients who fall into American Society of Anesthesiologists (ASA) Class ≥ IV\n* History of chronic alcohol or drug abuse within 2 years of the screening visit\n* Chronic renal failure or on dialysis\n* Significant complicating medical history or immunocompromised\n* History or presence of pre-existing autoimmune connective tissue disease, e.g., systemic lupus erythematosus or scleroderma\n* Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders;\n* Any medical condition which precludes compliance with the study\n* Subjects with any other clinically significant unstable medical disorder, life threatening disease, or conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and\u002For the soundness of this clinical study or which would contra-indicate a surgical procedure.\n* Previous or current history of being on regular analgesia \u002F pain killers","75 Years",{"count":200,"type":20},40,[23],"The 'Robotic Prostatectomy Artificial Intelligence Low Pressure Pain Study Trial' aims to assess the feasibility of being able to review operative outcomes such as pain when comparing two commonly used surgical devices for the removal of prostate cancers. The data collected will inform methodologies for future, larger, multi-center trials investigating pain in patients undergoing prostate cancer surgery.\n\nA robotic prostatectomy is a commonly performed surgery used to treat prostate cancer by removing the prostate gland. In order to perform the procedure, the surgeon must 'inflate' (technical term pneumoperitoneum) the patients abdomen with carbon dioxide gas using a device called an insufflator. Adequate 'inflation' of the abdomen ensures the surgeon can clearly visualise the prostate. Unfortunately, higher pressures of abdominal 'inflation' are a large contributor to intra and post-operative pain in patients having prostatectomies. The type of insufflator device used to maintain inflation pressures in the abdomen are thought to be a variable contributing to differing levels of intra and post-operative pain. Therefore, the purpose of this trial is to compare intra and post-operative pain when using two different insufflator devices when performing robotic prostatectomies. Both insufflators are already commonly used across multiple NHS Trusts.\n\n40 patients awaiting a robotic prostatectomy at the urology department at the Lister hospital, Stevenage, will be randomised to use either the Conventional Insufflator System (CIS) {Stryker PneumoClear Insufflator} or the AIRSEAL® Insufflation System (AIS) to 'inflate' their abdomens during their prostatectomies. Data relating to various intra and post-operative outcomes will be collected in the 30 days following the patient's operation. Outcomes include levels of intra and post-operative pain, medication use, procedure time, recovery room time, length of hospital stay, post operative nausea and vomiting and adverse events. This data can be analysed to identify trends in differences in outcomes between the AIS and CIS insufflators.",[204,205,206,207,208,30],"Prostate Cancer (Adenocarcinoma)","Prostate Cancer (Post Prostatectomy)","Prostate Cancer Surgery","Prostate Cancers","Prostate Neoplasm",[210,211,212,213,214,215,216,217,218],"prostate cancer","prostatectomy","robotic prostatectomy","post-operative pain","pain","Stryker PneumoClear insufflator","AirSeal Insufflation System","intra-operative pain","Medasense","2025-03-31",{"date":221,"type":36},"2025-04-08",{"date":223,"type":20},"2025-04-01",{"date":225,"type":20},"2025-07-01",{"name":227,"class":228},"East and North Hertfordshire NHS Trust","OTHER_GOV",{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":145,"enrollmentInfo":236,"targetDuration":4,"studyType":21,"phases":238,"briefSummary":239,"conditions":240,"keywords":242,"overallStatus":181,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":106},"100567536","comparison-of-the-efficacy-of-perineal-and-anal-electrical-stimulation-in-patients-with-urinary-incontinence-after-radical-prostatectomy-100567536","NCT06669468","Comparison of the Efficacy of Perineal and Anal Electrical Stimulation in Patients with Urinary Incontinence After Radical Prostatectomy","Comparison of the Efficacy of Perineal and Anal Electrical Stimulation in Patients with Urinary Incontinence After Radical Prostatectomy. a Prospective Randomised Controlled Trial","Inclusion Criteria:\n\n* 18-80 years old\n* Men with RP with incontinence over \\>50 g\u002F24 h and no residual cancer after RP on pathological examination\n* Men within 1 month to 1 year after catheter removal\n* Willingness to complete and do the QoL scale.\n* Understanding procedures, benefits, and possible side effects.\n* Being able to give written, informed consent.\n\nExclusion Criteria:\n\n* UI history before RP.\n* History of conservative treatment after RP including ES.\n* Prolonged indwelling urethral catheterization (more than 15 days).\n* Previous urological surgery history.\n* Men receiving radiotherapy.\n* Presence of urethral stricture and urinary tract infection.\n* Heart failure, presence of a pacemaker, implanted defibrillator.\n* Transurethral resection of the prostate due to benign prostatic hyperplasia.\n* Use of drugs that may affect bladder function (antimuscarinic, duloxetine, tricyclic antidepressant, etc.).",{"count":237,"type":20},93,[23],"Radical prostatectomy (RP) is a common procedure for the treatment of prostate cancer. However, postoperative urinary incontinence (UI) is an important reason for morbidity. UI negatively affects the quality of life in 30-50% of patients, especially in the early period (3 weeks to 6 months). However, it takes approximately 1 year to achieve continence (1).\n\nConservative treatment methods include pelvic floor muscle exercises (PFME) with or without biofeedback (BF), anal and perineal electrical stimulation (ES), magnetic stimulation (MS), compression (penile clamps), lifestyle changes and combinations of these methods (2).\n\nES artificially stimulates the pudendal nerve and its branches to cause direct and reflex responses of the urethral and periurethral striated muscles in women. ES also inhibits detrusor overactivity (3,4). There is conflicting evidence as to whether the addition of ES to treatment increases the efficacy of PFME alone in patients with UI after RP (Level of evidence:1b), (5). However, ES may benefit PFME for up to six months (Level of evidence: 2b), (5). Non-neurogenic male incontinence guidelines recommend PFME alone or in combination with BF and\u002For ES for men undergoing RP to accelerate improvement of UI (5).\n\nMany studies have shown that anal ES alone (1,7,8) or in combination with PFME (4,9,10,11) is more effective than untreated (4,7,9,11) or placebo ES (8,12). There are only two randomised controlled trials in the literature evaluating the efficacy of perineal ES in patients with UI after RP (13,14). In the study by Yıldız et al. (13), the group receiving perineal ES and the control group receiving no treatment were compared in patients who developed UI after RP. The results showed that incontinence severity, incontinence episodes, quality of life and anxiety parameters improved significantly in the 8th week in the group receiving perineal ES compared to the control group. In the study by Pané-Alemany et al. (14), a group receiving perianal ES and a group receiving anal ES were compared in patients who developed UI after RP. In the study, it was shown that the efficacy of the two treatments was not statistically different.\n\nOur study is the first prospective randomised controlled trial to evaluate the efficacy of perineal and anal ES added to PFME in patients with UI after RP. The aim of this study was to evaluate the efficacy of perineal ES and anal ES added to PFME on clinical parameters related to UI, quality of life and sexual functions, depression and anxiety. In addition, patients' preparation time for stimulation, treatment satisfaction and discomfort levels will be evaluated.",[30,241],"Urinary Incontinence",[243,244,245,246],"Anal Electrical Stimulation","Perineal Electrical Stimulation","Radical Prostatectomy","İncontinence","2024-10-31",{"date":249,"type":36},"2024-11-01",{"date":251,"type":20},"2024-11-30",{"date":253,"type":20},"2026-02-28",{"name":255,"class":72},"Pamukkale University",{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":16,"minAge":263,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":21,"phases":266,"briefSummary":267,"conditions":268,"keywords":270,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":106},"100561415","effect-of-high-intensity-focused-electromagnetic-hifem-technology-in-the-treatment-of-sui-in-chinese-men-undergone-robotic-radical-prostatectomy-100561415","NCT06589869","Effect of High-Intensity Focused Electromagnetic (HIFEM) Technology in the Treatment of SUI in Chinese Men Undergone Robotic Radical Prostatectomy","To Investigate the Effect of High-Intensity Focused Electromagnetic (HIFEM) Technology in the Treatment of Stress Urinary Incontinence Compared With Standard of Care in Chinese Men Who Had Undergone Robotic Radical Prostatectomy","Inclusion Criteria:\n\n* Undergone robotic radical prostatectomy\n* Able to carry out 1-hour pad test\n* Voluntary participation and signing of the informed consent form\n\nExclusion Criteria:\n\n* Pre-existing stress urinary incontinence\n* Post-void residual urine greater than 200ml\n* Active urinary tract infection\n* Urethral or bladder fistula\n* History of pelvic irradiation\n* Neurological condition (Spinal cord problems, stroke with poor neurological recovery, epilepsy, Parkinson disease, multiple sclerosis)\n* Previous surgery for SUI\n* Concurrent medication with diuretics, serotonin-norepinephrine reuptake inhibitors or any other medication known to worsen incontinence\n* Condition contraindicated for electromagnetic therapy i.e. Arrhythmia, on a pacemaker or implanted metallic device; Coagulopathy or on anticoagulant","18 Months",{"count":265,"type":20},184,[23],"This is a prospective, randomized trial to evaluate the efficacy and safety of High-Intensity Focused Electromagnetic (HIFEM) Technology in the treatment of stress urinary incontinence compared with standard of care in Chinese men who had undergone robotic radical prostatectomy.",[269,30],"Urinary Incontinence , Stress",[271,211],"stress urinary incontinence",{"date":273,"type":36},"2024-09-19",{"date":275,"type":36},"2022-07-29",{"date":277,"type":20},"2026-06",{"name":279,"class":72},"Chinese University of Hong Kong"]