Condition category
Urological and Genital Diseases
Date applied
14/07/2010
Date assigned
29/07/2010
Last edited
05/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tarinee Manchana

ORCID ID

Contact details

Department of Obstetrics and Gynecology
Faculty of Medicine
Chulalongkorn Univeristy
1873 Rama IV
Patumwan
Bangkok
10330
Thailand

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

Sponsor information

Organisation

Chulalongkorn University (Thailand)

Sponsor details

Ratchadapiseksompotch Fund
Faculty of Medicine
1873 Rama IV
Patumwan
Bangkok
10330
Thailand

Sponsor type

University/education

Website

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

  1. 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.

Additional files

Editorial Notes