Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Bethanechol Chloride for prevention of bladder dysfunction after radical hysterectomy
Study information
Scientific title
Acronym
Study hypothesis
To evaluate the efficacy of bethanechol chloride compared with placebo for prevention of bladder dysfunction in gynecologic cancer patients undergoing type III radical hysterectomy
Ethics approval
The Institutional Review Board of the Faculty of Medicine, Chulalongkorn University approved on the 19th of July 2007 (ref: 484/2007)
Study design
Randomised placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Bladder dysfunction after radical hysterectomy
Intervention
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.
Intervention type
Drug
Phase
Phase III
Drug names
Bethanechol chloride (Ucholine®)
Primary outcome measures
The incidence of urethral catheter removal at 1 week postoperatively
Secondary outcome measures
1. Median duration of urethral catheterization
2. Adverse events
3. Incidence of urinary tract infection at 1 month postoperatively
Overall trial start date
01/08/2007
Overall trial end date
31/03/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Early stage cervical cancer or endometrial cancer patients who have undergone type III radical hysterectomy
2. Age 20-75 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
62
Participant exclusion criteria
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
Recruitment start date
01/08/2007
Recruitment end date
31/03/2010
Locations
Countries of recruitment
Thailand
Trial participating centre
Department of Obstetrics and Gynecology
Bangkok
10330
Thailand
Funders
Funder type
University/education
Funder name
Chulalongkorn University (Thailand) - Faculty of Medicine, Ratchadapiseksompotch Fund (Grant No.: RA049/50)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21546875
Publication citations
-
Results
Manchana T, Prasartsakulchai C, Bethanechol chloride for the prevention of bladder dysfunction after radical hysterectomy in gynecologic cancer patients: a randomized controlled trial study., Int. J. Gynecol. Cancer, 2011, 21, 4, 730-736, doi: 10.1111/IGC.0b013e3181f7d6de.