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

NCT ID: NCT02910596

Last Updated: 2020-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2017-05-31

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.

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.

Conditions

Bladder Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

bethanechol chloride

Intervention Type: DRUG

bethanechol chloride(10) 2 tablets oral tid, ac. Start on3rd - 5th postoperative day

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

Group Type: EXPERIMENTAL

early bladder training

Intervention Type: DEVICE

early bladder training start on 3rd - 5thpostoperative day

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

Group Type: EXPERIMENTAL

early bladder training and bethanechol chloride

Intervention Type: OTHER

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

Group Type: OTHER

no early bladder training and no bethanechol chloride

Intervention Type: OTHER

no bethanechol chloride and no early bladder training

Interventions

bethanechol chloride

bethanechol chloride(10) 2 tablets oral tid, ac. Start on3rd - 5th postoperative day

Intervention Type: DRUG

early bladder training

early bladder training start on 3rd - 5thpostoperative day

Intervention Type: DEVICE

early bladder training and bethanechol chloride

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

Intervention Type: OTHER

no early bladder training and no bethanechol chloride

no bethanechol chloride and no early bladder training

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Department of Medical Services Ministry of Public Health of Thailand

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Narisa Jenrungrojsakul, MD

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

RJBLA

Identifier Type: -

Identifier Source: org_study_id