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ISRCTN
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ISRCTN92687416
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ClinicalTrials.gov identifier
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Public title
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Bethanechol Chloride for prevention of bladder dysfunction after radical hysterectomy in gynecologic cancer patients: A Randomised controlled trial study
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Scientific title
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Acronym
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N/A
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Serial number at source
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Bethanechol Chloride for prevention of bladder dysfunction after radical hysterectomy
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Study hypothesis
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To evaluate the efficacy of bethanechol chloride compared with placebo for prevention of bladder dysfunction in gynecologic cancer patients undergoing type III radical hysterectomy
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Lay summary
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Not provided at time of registration
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Ethics approval
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The Institutional Review Board of the Faculty of Medicine, Chulalongkorn University approved on the 19th of July 2007 (ref: 484/2007)
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Study design
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Randomised placebo controlled trial
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Countries of recruitment
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Thailand
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Disease/condition/study domain
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Bladder dysfunction after radical hysterectomy
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Participants - inclusion criteria
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1. Early stage cervical cancer or endometrial cancer patients who have undergone type III radical hysterectomy
2. Age 20-75 years
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Participants - exclusion criteria
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1. Hypersensitivity to bethanechol chloride
2. Active bronchial asthma
3. Hyperthyroidism
4. Hypotension
5. Tachycardia
6. Vasomotor instability
7. Coronary artery disease
8. Epilepsy
9. Parkinsonism
10. Gastrointestinal obstruction
11. Bladder neck obstruction
12. Recent urinary bladder surgery
13. Gastrointestinal resection with anastomosis
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Anticipated start date
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01/08/2007
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Anticipated end date
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31/03/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet
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Target number of participants
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62
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Interventions
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Treatment group received bethanechol chloride (Ucholine®) 20 mg three times a day, 1 hour before meal on 3rd -7th postoperative day (POD).
The control group received a placebo which had a similar appearance to bethanechol chloride.
Participants will have regular visits every 3 months within the first 2 years, then 4-6 months until 5 years.
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Primary outcome measure(s)
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The incidence of urethral catheter removal at 1 week postoperatively
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Secondary outcome measure(s)
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1. Median duration of urethral catheterization
2. Adverse events
3. Incidence of urinary tract infection at 1 month postoperatively
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Sources of funding
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Chulalongkorn University (Thailand) - Faculty of Medicine, Ratchadapiseksompotch Fund (Grant No.: RA049/50)
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Trial website
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Publications
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2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21546875
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Contact name
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Dr
Tarinee
Manchana
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Address
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Department of Obstetrics and Gynecology
Faculty of Medicine
Chulalongkorn Univeristy
1873 Rama IV
Patumwan
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City/town
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Bangkok
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Zip/Postcode
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10330
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Country
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Thailand
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Sponsor
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Chulalongkorn University (Thailand)
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Address
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Ratchadapiseksompotch Fund
Faculty of Medicine
1873 Rama IV
Patumwan
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City/town
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Bangkok
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Zip/Postcode
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10330
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Country
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Thailand
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Date applied
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14/07/2010
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Last edited
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05/10/2011
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Date ISRCTN assigned
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29/07/2010
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