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OpenTrials
Completed

NCT Number: NCT02910596

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.

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Key information

Conditions

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Narisa Jenrungrojsakul, MD

Bangkok, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bethanechol chloride

Drug

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

early bladder training

Device

early bladder training start on 3rd - 5thpostoperative day

early bladder training and bethanechol chloride

Other

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

no early bladder training and no bethanechol chloride

Other

no bethanechol chloride and no early bladder training

Primary outcomes

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

    Time frame: 5 days postoperative

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 22, 2016
Registry last updated
Oct 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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