Bladder DysfunctionPhase 4NCT02910596
Effectiveness of Bethanechol Chloride and Early Bladder Training for Prevention of Bladder Dysfunction After Radical Hysterectomy in Cervical Cancer Stage IB - IIA
A Phase 4 study testing bethanechol chloride, early bladder training and early bladder training and bethanechol chloride in people with Bladder Dysfunction, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
Compare the effectiveness of bethanechol chloride and early bladder training for prevention of bladder dysfunction after radical hysterectomy in cervical cancer stage IB - IIA. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bladder Dysfunction
- What is being tested?
- bethanechol chloride, early bladder training and early bladder training and bethanechol chloride
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteThailand
- Study dates
- 1 Oct 2016to 31 May 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women with cervical cancer stage IB - IIA underwent standard type III radical hysterectomy, both open and laparoscopic approach
- Patient aged 20 - 65 years
- Patient able to give free and informed consent and who agrees to participate be signing the consent form
Who cannot join
- Patient who had an allergic reaction to bethanechol chloride
- Patient who had neurogenic bladder
Trial locations and contacts
1 site in 1 country.
About this study
Compare the effectiveness of bethanechol chloride and early bladder training for prevention of bladder dysfunction after radical hysterectomy in cervical cancer stage IB - IIA.
Read the detailed description
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.
- Conditions
- Bladder Dysfunction
- Being tested
- bethanechol chloride, early bladder training, early bladder training and bethanechol chloride, no early bladder training and no bethanechol chloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bethanechol chlorideDrug
bethanechol chloride(10) 2 tablets oral tid, ac. Start on3rd - 5th postoperative day
early bladder trainingDevice
early bladder training start on 3rd - 5thpostoperative day
early bladder training and bethanechol chlorideOther
bethanechol chloride 2 tablets oral tid, ac and early bladder training start on 3rd - 5th postoperative day
no early bladder training and no bethanechol chlorideOther
no bethanechol chloride and no early bladder training
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | * 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 Receives: Drug: bethanechol chloride |
| B | Experimental | * 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 Receives: Device: early bladder training |
| C | Experimental | * 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 Receives: Other: early bladder training and bethanechol chloride |
| D | Other | -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 Receives: Other: no early bladder training and no bethanechol chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of retrained urethral catheterization(day) after standard type III radical hysterectomy
Measured: 5 days postoperative
Secondary outcomes (3)
Rate of urethral catheter removal at 5 days postoperative
Measured: 5 days postoperative
Incidence of urinary tract infection at 28 days postoperative
Measured: 28 days postoperative
Volume of postvoid residual urine at 28 days postoperative
Measured: 28 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study start1 Oct 2016
- Primary completion31 Mar 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910596
- Sponsor's protocol ID
- RJBLA
- Status last verified
- Sep 2016
- First submitted
- 20 Sep 2016
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Bethanechol Chloride and Early Bladder Training for Prevention of Bladder Dysfunction After Radical Hysterectomy in Cervical Cancer Stage IB - IIA
- ClinicalTrials.gov ID
- NCT02910596
- Acronym / sponsor ID
- RJBLA
- Conditions
- Bladder Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare the effectiveness of bethanechol chloride and early bladder training for prevention of bladder dysfunction after radical hysterectomy in cervical cancer stage IB - IIA.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: bethanechol chloride* 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 |
| B | Experimental | Device: early bladder training* 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 |
| C | Experimental | Other: early bladder training and bethanechol chloride* 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 |
| D | Other | Other: no early bladder training and no 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 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women with cervical cancer stage IB - IIA underwent standard type III radical hysterectomy, both open and laparoscopic approach
- Patient aged 20 - 65 years
- Patient able to give free and informed consent and who agrees to participate be signing the consent form
Key exclusion criteria (2 listed)
- Patient who had an allergic reaction to bethanechol chloride
- Patient who had neurogenic bladder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bethanechol chloridebethanechol chloride(10) 2 tablets oral tid, ac. Start on3rd - 5th postoperative day | Drug | A |
| early bladder trainingearly bladder training start on 3rd - 5thpostoperative day | Device | B |
| early bladder training and bethanechol chloridebethanechol chloride 2 tablets oral tid, ac and early bladder training start on 3rd - 5th postoperative day | Other | C |
| no early bladder training and no bethanechol chlorideno bethanechol chloride and no early bladder training | Other | D |
Primary outcome
Duration of retrained urethral catheterization(day) after standard type III radical hysterectomy
Time frame: 5 days postoperative
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bethanechol chloride, early bladder training and early bladder training and bethanechol chloride in people with Bladder Dysfunction, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of retrained urethral catheterization(day) after standard type III radical hysterectomy (time frame: 5 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.