A Phase 4 interventional study of bethanechol chloride and early bladder training in Bladder Dysfunction, sponsored by Rajavithi Hospital. Completed at 1 site in Thailand. Open to female participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-23.
Sponsored by Rajavithi Hospital · Phase 4, Interventional, and Prevention
Compare the effectiveness of bethanechol chloride and early bladder training for prevention of bladder dysfunction after radical hysterectomy in cervical cancer stage IB - IIA.
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.
Rajavithi Hospital is the lead sponsor of 46 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* Ucholine(Bethanechol chloride, 10 mg) 2 tablets oral tid, ac Start on 3rd - 5th postoperative day * In bethanechol chloride arm arm should be vital signs were monitored every 30 minute on first hour then every 4 hours on first day. Any adverse event were recorded. * Remove urethral catheter on 5thpostoperative day. Void volume and postvoid residual urine were record. 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
Drug: bethanechol chloride
* 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
Device: early bladder training
* Early bladder training and Ucholine(Bethanechol chloride, 10 mg) 2 tablets oral tid, ac Start on 3rd - 5th postoperative day * should be vital signs were monitored every 30 minute on first hour then every 4 hours on first day. Any adverse event were recorded. * 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: early bladder training and bethanechol chloride
-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
bethanechol chloride(10) 2 tablets oral tid, ac. Start on3rd - 5th postoperative day
early bladder training start on 3rd - 5thpostoperative day
bethanechol chloride 2 tablets oral tid, ac and early bladder training start on 3rd - 5th postoperative day
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
Plan to share: No
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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Rajavithi Hospital