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IRCT20220121053778N1 IRCT 2022-06-06 Islamic Azad University The effect of suprapubic catheters on painful bladder spasms Comparison of incidence of painful bladder spasm between Pezzer catheter and 3-way Foley catheter used for suprapubic catheterization after open simple prostatectomy 2021-05-22 anticipated 159 Complete https://irct.ir/trial/61507 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: In the implementation of this clinical trial intervention, which is a single blind study, participants (patients) are selected based on the inclusion criteria. After obtaining informed consent to conduct research in the intervention groups, they are classified and kept blind. N/A Condition 1: Benign Prostatic Hyperplasia. Condition 2: Painful Bladder Spasms. Condition 3: Prostate cancer. Intervention 1: Intervention group: a. Intervention 2: Intervention group: b. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No informations available.
public Mojtaba Farahani
No. 50, Riazatkesh Alley, Deylaman jonoubi St, Imam Hossein St, Rey, Tehran
Tehran Iran (Islamic Republic of) 1848834661 +98 21 5595 3612 everlasting@gmail.com Islamic Azad University scientific Mojtaba Farahani
No. 50, Riazatkesh Alley, Deylaman jonoubi St, Imam Hossein St, Rey, Tehran
Tehran Iran (Islamic Republic of) 1848834661 +98 21 5595 3612 everlasting@gmail.com Islamic Azad University Iran (Islamic Republic of) Patients with severe complications from enlarged prostate including: refractory urinary retention, persistent gross hematuria, bladder stones, recurrent UTI, evidence of upper or lower urinary tract dysfunction (such as azotemia / uremia), and urinary incontinence Overflow / urge type and prostate weighing more than 65-70 grams (estimated by DRE examination and ultrasound) are candidates for open prostatectomy and inclusion in the study. Patients with suspected prostate cancer (with increased PSA or abnormal DRE) can be candidates for open prostatectomy if the prostate biopsy test is negative. no limit no limit Male Atonic bladder (confirmed by urodynamic study) Urinary disorders not related to BPH such as neurogenic bladder disorder History of pelvic surgery, including previous prostate or urethral surgery History of coagulation disorders Chronic pain condition History of opioid use N40.1 N39.82 C61 Enlarged prostate with lower urinary tract symptoms Other specified disorders of bladder Malignant neoplasm of prostate Treatment - Devices Treatment - Devices Intervention group: a Intervention group: b Bladder Pain Score. Timepoint: Measurement of bladder pain score after surgery during the patient's hospitalization. Method of measurement: Bladder spasm symptom scale. Bladder Pain Score. Timepoint: Measurement of bladder pain score after surgery during the patient's hospitalization. Method of measurement: Visual Analogue Scale. Painkiller dosage. Timepoint: During Post operation hospitalization. Method of measurement: According to the documented prescription. Islamic Azad University Approved 2021-02-21 Ethics in research committee of Tehran Azad University of Medical Sciences No. 50, Riazatkesh Alley, Deylaman jonoubi St, Rey, Tehran ری Tehran Iran (Islamic Republic of)