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

NCT02910596 | Completed Phase 4

• 1 other identifier: RJBLA
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Dysfunction

Outcome Measures

Primary Outcomes (1)

• Duration of retrained urethral catheterization(day) after standard type III radical hysterectomy

  5 days postoperative

Secondary Outcomes (3)

• 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

Study Arms (4)

A

EXPERIMENTAL

* 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

B

EXPERIMENTAL

* 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

C

EXPERIMENTAL

* 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

D

OTHER

-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

Interventions

bethanechol chloride DRUG

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

A

early bladder training DEVICE

early bladder training start on 3rd - 5thpostoperative day

B

early bladder training and bethanechol chloride OTHER

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

C

no early bladder training and no bethanechol chloride OTHER

no bethanechol chloride and no early bladder training

D

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient who had an allergic reaction to bethanechol chloride
• Patient who had neurogenic bladder

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Narisa Jenrungrojsakul, MD

Bangkok, 10400, Thailand

Location

MeSH Terms

Interventions

Bethanechol

Intervention Hierarchy (Ancestors)

Bethanechol Compounds; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Onium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 22, 2016
• Study Start: October 1, 2016
• Primary Completion: March 31, 2017
• Study Completion: May 31, 2017
• Last Updated: October 23, 2020

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)