Bethanechol Chloride for prevention of bladder dysfunction after radical hysterectomy in gynecologic cancer patients: A Randomised controlled trial study
| ISRCTN | ISRCTN92687416 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92687416 |
| Secondary identifying numbers | Bethanechol Chloride for prevention of bladder dysfunction after radical hysterectomy |
- Submission date
- 14/07/2010
- Registration date
- 29/07/2010
- Last edited
- 05/10/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Tarinee Manchana
Scientific
Scientific
Department of Obstetrics and Gynecology
Faculty of Medicine
Chulalongkorn Univeristy
1873 Rama IV
Patumwan
Bangkok
10330
Thailand
Study information
| Study design | Randomised placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | 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(s) | The Institutional Review Board of the Faculty of Medicine, Chulalongkorn University approved on the 19th of July 2007 (ref: 484/2007) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Bethanechol chloride (Ucholine®) |
| Primary outcome measure | 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 study start date | 01/08/2007 |
| Completion date | 31/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 62 |
| Key inclusion criteria | 1. Early stage cervical cancer or endometrial cancer patients who have undergone type III radical hysterectomy 2. Age 20-75 years |
| Key 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 |
| Date of first enrolment | 01/08/2007 |
| Date of final enrolment | 31/03/2010 |
Locations
Countries of recruitment
- Thailand
Study participating centre
Department of Obstetrics and Gynecology
Bangkok
10330
Thailand
10330
Thailand
Sponsor information
Chulalongkorn University (Thailand)
University/education
University/education
Ratchadapiseksompotch Fund
Faculty of Medicine
1873 Rama IV
Patumwan
Bangkok
10330
Thailand
"ROR" |
https://ror.org/028wp3y58 |
|---|
Funders
Funder type
University/education
Chulalongkorn University (Thailand) - Faculty of Medicine, Ratchadapiseksompotch Fund (Grant No.: RA049/50)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2011 | Yes | No |
