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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|ClinicalTrials.gov Identifier: NCT02910596|
Recruitment Status : Completed
First Posted : September 22, 2016
Last Update Posted : October 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Bladder Dysfunction||Drug: bethanechol chloride Device: early bladder training Other: early bladder training and bethanechol chloride Other: no early bladder training and no bethanechol chloride||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Actual Study Start Date :||October 1, 2016|
|Actual Primary Completion Date :||March 31, 2017|
|Actual Study Completion Date :||May 31, 2017|
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
-Remove urethral catheter on 5th postoperative day. Void volume and postvoid residual urine were recorded. Intermittent urethral catheterization was used to measure postvoid residual urine. If postvoid residual urine was more than 100 cc in two consecutive measurement, the urethral catheter was reinserted, and medication would be continue until the catheter cloud be removed but medication were not given for more than 1 month. Postvoid residual urine, urinalysis were evaluated at 1 month postoperative
Other: no early bladder training and no bethanechol chloride
no bethanechol chloride and no early bladder training
- Duration of retrained urethral catheterization(day) after standard type III radical hysterectomy [ Time Frame: 5 days postoperative ]
- Rate of urethral catheter removal at 5 days postoperative [ Time Frame: 5 days postoperative ]
- Incidence of urinary tract infection at 28 days postoperative [ Time Frame: 28 days postoperative ]
- Volume of postvoid residual urine at 28 days postoperative [ Time Frame: 28 days postoperative ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910596
|Narisa Jenrungrojsakul, MD|
|Bangkok, Thailand, 10400|