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

Bladder Dysfunction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02910596
• Other study ID #: RJBLA
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2016
• Est. completion date: May 31, 2017

Study information

• Verified date: September 2016
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Dysfunction

Intervention

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

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

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

Locations

Country	Name	City	State
Thailand	Narisa Jenrungrojsakul, MD	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of retrained urethral catheterization(day) after standard type III radical hysterectomy		5 days postoperative
Secondary	Rate of urethral catheter removal at 5 days postoperative		5 days postoperative
Secondary	Incidence of urinary tract infection at 28 days postoperative		28 days postoperative
Secondary	Volume of postvoid residual urine at 28 days postoperative		28 days postoperative