Clinical trial NCT02910596: Effectiveness of Bethanechol Chloride and Early Bladder Training for Prevention of Bladder Dysfunction After Radical Hysterectomy in Cervical Cancer Stage IB - IIA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bladder Dysfunction
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2016-09-22
Enrollment: 56
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of retrained urethral catheterization(day) after standard type III radical hysterectomy
timeFrame: 5 days postoperative
Secondary outcomes:
measure: Rate of urethral catheter removal at 5 days postoperative
timeFrame: 5 days postoperative
measure: Incidence of urinary tract infection at 28 days postoperative
timeFrame: 28 days postoperative
measure: Volume of postvoid residual urine at 28 days postoperative
timeFrame: 28 days postoperative
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Narisa Jenrungrojsakul, MD
Study officials:
References: