Bladder Dysfunction
Conditions
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.
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.
Interventions
DRUGbethanechol chloride
bethanechol chloride(10) 2 tablets oral tid, ac. Start on3rd - 5th postoperative day
DEVICEearly bladder training
early bladder training start on 3rd - 5thpostoperative day
OTHERearly bladder training and bethanechol chloride
bethanechol chloride 2 tablets oral tid, ac and early bladder training start on 3rd - 5th postoperative day
OTHERno early bladder training and no bethanechol chloride
no bethanechol chloride and no early bladder training
Sponsors
Department of Medical Services Ministry of Public Health of Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of retrained urethral catheterization(day) after standard type III radical hysterectomy | 5 days postoperative |
Secondary
| 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 |
Countries
Thailand
Outcome results
None listed