NCT02910596

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Department of Medical Services Ministry of Public Health of Thailand · Other Government
• Sex: Female
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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
OTHER	no early bladder training and no bethanechol chloride	no bethanechol chloride and no early bladder training

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-03-31
• Completion: 2017-05-31
• First posted: 2016-09-22
• Last updated: 2020-10-23

Locations

1 site across 1 country: Thailand