Lower Urinary Tract Symptoms Clinical Trial
Official title:
The Safety and Efficacy of Irreversible Electroporation Versus Standard Medication for the Treatment of Benign Prostatic Obstruction: a Randomized Controlled Trial
Verified date | February 2018 |
Source | Changhai Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Irreversible electroporation (IRE) is a novel ablation modality using electric pulses to create nanoscale defects in the cell membrane. It has been verified to be safe on the treatment of prostate, lung, liver and kidney masses. The present is a randomized, controlled trial, with a main purpose of looking into the safety and feasibility of irreversible electroporation for patients with benign prostatic obstruction.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | May 30, 2019 |
Est. primary completion date | January 31, 2019 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 45 Years and older |
Eligibility |
Inclusion Criteria: 1. Male, 45 years or older. 2. The presence of voiding symptoms, i.e. slow stream, intermittent stream, hesitancy, straining, etc. 3. Qmax = 5 mL/s and = 15 mL/s with minimum voided volume of 125 mL or more during flow study. 4. The presence of bladder outlet obstruction during pressure-flow study. 5. International Prostatic Symptom Score (IPSS) = 12 at screening. 6. Prostate volume = 30 ml (using a transrectal ultrasound approach). 7. Total serum prostatic specific antigen (PSA) = 1.5 ng/mL and = 10 ng/mL at screening. 8. Subject is able to communicate and complete the questionnaires properly. 9. Written informed consent. Exclusion Criteria: 1. Diagnosis or suspicion of bladder, prostate, urethral or pelvic tumor. 2. Patients with arrhythmia or history of cardiac pacemaker implantation. 3. Known lower urinary tract or pelvic surgical history. 4. Voiding symptoms as a result of urethral stricture, stone diseases, chronic prostatitis, space-occupying lesions etc. 5. Known neurogenic or congenital lower urinary tract dysfunction. 6. Rigid or flexible cystoscopy examination within the past 7 days at screening. 7. Existence of anatomical abnormalities of the urinary tract (e.g. diverticulum of the bladder or urethra, ectopic ureteral orifice etc.). 8. The presence of acute conditions, such as, urinary tract infection, fever, heart failure etc. 9. Patients with poor compliance or cognitive competence. |
Country | Name | City | State |
---|---|---|---|
China | Changhai Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Changhai Hospital |
China,
Wagstaff PG, Buijs M, van den Bos W, de Bruin DM, Zondervan PJ, de la Rosette JJ, Laguna Pes MP. Irreversible electroporation: state of the art. Onco Targets Ther. 2016 Apr 22;9:2437-46. doi: 10.2147/OTT.S88086. eCollection 2016. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The changes of maximum flow rate (ml/s) between baseline and during follow-up | Maximum flow rate will be measured using urinary flow study | Measured at baseline and 1, 3, 6 months during follow-up | |
Secondary | The changes of IPSS scores between baseline and during follow-up | Measured using a standard IPSS scoring system | Measured at baseline and 1, 3, 6 months during follow-up | |
Secondary | The changes of IIEF scores between baseline and during follow-up | Measured using a standard IIEF scoring system | Measured at baseline and 1, 3, 6 months during follow-up | |
Secondary | The changes of maximum detrusor pressure at maximum flow rate between baseline and during follow-up | The data will be captured during pressure flow study | Measured at baseline and 3, 6 months during follow-up | |
Secondary | The changes of post void residual volume (ml) between baseline and follow-up | Post void residual volume (ml) will be measured via ultrasound | Measured at baseline and 1, 3, 6 months during follow-up | |
Secondary | The changes of prostate volume (ml) between baseline and follow-up | Prostate volume (ml) will be measured using transrectal prostate ultrasound and calculated as: prostate volume (ml) = length (mm) * width (mm) * height (mm) * 0.52. | Measured at baseline and 1, 3, 6 during follow-up |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04856748 -
Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
|
||
Completed |
NCT03623880 -
Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders
|
N/A | |
Enrolling by invitation |
NCT06317116 -
Examining the Relationship Between Core Muscles and Bladder Issues in Children
|
||
Completed |
NCT03625843 -
Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing
|
N/A | |
Recruiting |
NCT05814614 -
Bladder Complaints in Parkinson's Disease Effectiveness of Pelvic Floor Muscle Exercises and Electrical Stimulation
|
N/A | |
Recruiting |
NCT04288427 -
5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy
|
N/A | |
Not yet recruiting |
NCT06452927 -
EEP in Patients With Urodynamically Proven DU/DA
|
N/A | |
Completed |
NCT02330107 -
Auriculotherapy on Lower Urinary Tract Symptoms in Elderly Men
|
N/A | |
Completed |
NCT03339609 -
Uroflow Measurement With Electromyography (EMG) to Identify Lower Urinary Tract Symptoms (LUTS): Conducted on Healthy Children
|
N/A | |
Terminated |
NCT02003742 -
Efficacy and Safety of a Single TRUS-guided Intraprostatic Injection of NX-1207 in Patients With LUTS Due to BPH
|
Phase 3 | |
Terminated |
NCT01003249 -
Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen
|
Phase 4 | |
Completed |
NCT01078545 -
Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms (LUTS)
|
N/A | |
Completed |
NCT02074644 -
Clinical Trial of Prostatic Arterial Embolization Versus a Sham Procedure to Treat Benign Prostatic Hyperplasia
|
N/A | |
Recruiting |
NCT03802851 -
HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer
|
N/A | |
Active, not recruiting |
NCT05415748 -
Deprescribing Tamsulosin in Older Men
|
Phase 4 | |
Recruiting |
NCT05702294 -
Electronic Urinary Flowmeter to Improve Accuracy of Bladder Diaries .
|
N/A | |
Enrolling by invitation |
NCT05537272 -
The Efficacy of Tamsulosin and Tadalafil Compared to Placebo in the Treatment and Prevention of Urinary Disorders After Transperineal Prostate Biopsy
|
Phase 4 | |
Recruiting |
NCT05826691 -
Benign Prostate Surgery and QOL and Sexual Function
|
||
Completed |
NCT04104100 -
Prevalence and Risk Factor of NP in Women With LUTS
|
||
Completed |
NCT04190641 -
Single-use Cystoscope System for Direct Visualization of the Urethra and Bladder
|
N/A |