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

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ClinicalTrials.gov Identifier: NCT02910596
Recruitment Status : Unknown
Verified September 2016 by Rajavithi Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 22, 2016
Last Update Posted : October 3, 2016
Sponsor:
Information provided by (Responsible Party):
Rajavithi Hospital

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

Condition or disease Intervention/treatment Phase
Bladder Dysfunction Drug: bethanechol chloride Device: early bladder training Other: early bladder training and bethanechol chloride Other: no early bladder training and no bethanechol chloride Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : October 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
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
Drug: bethanechol chloride
bethanechol chloride(10) 2 tablets oral tid, ac. Start on3rd - 5th postoperative day

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
Device: early bladder training
early bladder training start on 3rd - 5thpostoperative day

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: early bladder training and bethanechol chloride
bethanechol chloride 2 tablets oral tid, ac and early bladder training start on 3rd - 5th postoperative day

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
Other: no early bladder training and no bethanechol chloride
no bethanechol chloride and no early bladder training




Primary Outcome Measures :
  1. Duration of retrained urethral catheterization(day) after standard type III radical hysterectomy [ Time Frame: 5 days postoperative ]

Secondary Outcome Measures :
  1. Rate of urethral catheter removal at 5 days postoperative [ Time Frame: 5 days postoperative ]
  2. Incidence of urinary tract infection at 28 days postoperative [ Time Frame: 28 days postoperative ]
  3. Volume of postvoid residual urine at 28 days postoperative [ Time Frame: 28 days postoperative ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910596


Contacts
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Contact: Kanya Boonthongtho, MSc +6623548108 ext 2803 kanyanana@yahoo.com

Locations
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Thailand
Narisa Jenrungrojsakul, MD
Bangkok, Thailand, 10400
Contact: Narisa Jenrungrojsakul, MD    +66882810575    narisa.x@gmail.com   
Contact: Marut Yanaranop, MD    +23548108 ext 3226    myanaran@hotmail.com   
Sponsors and Collaborators
Rajavithi Hospital

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Responsible Party: Rajavithi Hospital
ClinicalTrials.gov Identifier: NCT02910596    
Other Study ID Numbers: RJBLA
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: October 3, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Bethanechol
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action