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

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 Overview

• Status: Completed
• Conditions: Bladder Dysfunction
• Intervention / Treatment: Drug: bethanechol chloride; Device: early bladder training; Other: early bladder training and bethanechol chloride; Other: no early bladder training and no bethanechol chloride

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Narisa Jenrungrojsakul, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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
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	Other: no early bladder training and no bethanechol chloride; no bethanechol chloride and no early bladder training

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rajavithi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): March 31, 2017
• Study Completion (Actual): May 31, 2017

Study Registration Dates

• First Submitted: September 20, 2016
• First Submitted That Met QC Criteria: September 21, 2016
• First Posted (Estimate): September 22, 2016

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Cholinergic Agonists; Parasympathomimetics; Muscarinic Agonists; Bethanechol
• Other Study ID Numbers: RJBLA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No