Effectiveness of Bethanechol Chloride and Early Bladder Training for Prevention of Bladder Dysfunction After Radical Hysterectomy in Cervical Cancer Stage IB – IIA

Overview

Compare the effectiveness of bethanechol chloride and early bladder training for prevention of bladder dysfunction after radical hysterectomy in cervical cancer stage IB – IIA.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 31, 2017

Detailed Description

Cervical cancer is the third most common cancer in women worldwide, after breast and colorectal cancer. Molecular biology has firmly established a causal relationship between persistent infection with high risk human papilloma virus (HPV) genotypes and cervical cancer. Cervical cancer stage IB1 and selected IIA 1 lesions without extensive vaginal involvement can be treated with either RH and pelvic lymph node dissection (PLD) or primary chemoradiation. Bladder dysfunction is the most common complication after radical hysterectomy. The incidence is approximate 10-80 %. Management of bladder dysfunction is continuous urethral catheterization or clean intermittent self-catheterization. Prolonged urethral catheterization may increase the risk of urinary tract infection. Early postoperative bladder training that consist of a scheduled clamping trans-urethral catheter every 3 h and unclamping trans-urethral catheter 15 min during the entire day. Bethanechol chloride is a cholinergic drug and may enhance the detrusor muscle contraction, resulting in higher maximum flow rate, and lower postvoid residual urine. This study was conducted to compare the effectiveness of bethanechol chloride and early bladder training for prevention of bladder dysfunction after radical hysterectomy in cervical cancer stage IB – IIA.

Interventions

  • Drug: bethanechol chloride
    • bethanechol chloride(10) 2 tablets oral tid, ac. Start on3rd – 5th postoperative day
  • Device: early bladder training
    • early bladder training start on 3rd – 5thpostoperative day
  • Other: early bladder training and bethanechol chloride
    • bethanechol chloride 2 tablets oral tid, ac and early bladder training start on 3rd – 5th postoperative day
  • Other: no early bladder training and no bethanechol chloride
    • no bethanechol chloride and no early bladder training

Arms, Groups and Cohorts

  • Experimental: A
    • Ucholine(Bethanechol chloride, 10 mg) 2 tablets oral tid, ac Start on 3rd – 5th postoperative day In bethanechol chloride arm arm should be vital signs were monitored every 30 minute on first hour then every 4 hours on first day. Any adverse event were recorded. Remove urethral catheter on 5thpostoperative day. Void volume and postvoid residual urine were record. Intermittent urethral catheterization was used to measure postvoid residual urine. If postvoid residual urine was more than 100 cc in two consecutive measurement, the urethral catheter was reinserted, and medication would be continue until the catheter cloud be removed but medication were not given for more than 1 month. Postvoid residual urine, urinalysis were evaluated at 1 month postoperative
  • Experimental: B
    • Early bladder training Start on 3rd – 5th postoperative day Remove urethral catheter on 5th postoperative day. Void volume and postvoid residual urine were recorded. Intermittent urethral catheterization was used to measure postvoid residual urine. If postvoid residual urine was more than 100 cc in two consecutive measurement, the urethral catheter was reinserted, and medication would be continue until the catheter cloud be removed but medication were not given for more than 1 month. Postvoid residual urine, urinalysis were evaluated at 1 month postoperative
  • Experimental: C
    • Early bladder training and Ucholine(Bethanechol chloride, 10 mg) 2 tablets oral tid, ac Start on 3rd – 5th postoperative day should be vital signs were monitored every 30 minute on first hour then every 4 hours on first day. Any adverse event were recorded. Remove urethral catheter on 5th postoperative day. Void volume and postvoid residual urine were recorded. Intermittent urethral catheterization was used to measure postvoid residual urine. If postvoid residual urine was more than 100 cc in two consecutive measurement, the urethral catheter was reinserted, and medication would be continue until the catheter cloud be removed but medication were not given for more than 1 month. Postvoid residual urine, urinalysis were evaluated at 1 month postoperative
  • Other: D
    • -Remove urethral catheter on 5th postoperative day. Void volume and postvoid residual urine were recorded. Intermittent urethral catheterization was used to measure postvoid residual urine. If postvoid residual urine was more than 100 cc in two consecutive measurement, the urethral catheter was reinserted, and medication would be continue until the catheter cloud be removed but medication were not given for more than 1 month. Postvoid residual urine, urinalysis were evaluated at 1 month postoperative

Clinical Trial Outcome Measures

Primary Measures

  • Duration of retrained urethral catheterization(day) after standard type III radical hysterectomy
    • Time Frame: 5 days postoperative

Secondary Measures

  • Rate of urethral catheter removal at 5 days postoperative
    • Time Frame: 5 days postoperative
  • Incidence of urinary tract infection at 28 days postoperative
    • Time Frame: 28 days postoperative
  • Volume of postvoid residual urine at 28 days postoperative
    • Time Frame: 28 days postoperative

Participating in This Clinical Trial

Inclusion Criteria

  • Women with cervical cancer stage IB – IIA underwent standard type III radical hysterectomy, both open and laparoscopic approach – Patient aged 20 – 65 years – Patient able to give free and informed consent and who agrees to participate be signing the consent form Exclusion Criteria:
  • Patient who had an allergic reaction to bethanechol chloride – Patient who had neurogenic bladder
  • Gender Eligibility: Female

    Minimum Age: 20 Years

    Maximum Age: 65 Years

    Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

    Investigator Details

    • Lead Sponsor
      • Rajavithi Hospital
    • Provider of Information About this Clinical Study
      • Sponsor

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