Uterine Cervical NeoplasmsPhase 2NCT01907646
Role of Bladder Training During Post-operative Hospital Stay After Radical Hysterectomy in Patients
A Phase 2 study testing bladder training and No bladder training in people with Uterine Cervical Neoplasms, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
The objective of the study is to evaluate the impact and the outcome of bladder training during post-operative hospital stay after radical hysterectomy, mainly after neoadjuvant concurrent chemo-radiation therapy for locally advanced cervical cancer. Read more about this study
- Who is it for?
- Ages 27 to 81 years, women only
- Conditions the study is for
- Uterine Cervical Neoplasms
- What is being tested?
- bladder training and No bladder training
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2009to Aug 2012
- Phase
- Phase 2
- 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 27 to 81 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who underwent Querleu-Morrow class B2 and class C1 RH were enrolled in this randomized prospective study.
Who cannot join
- -All the patients with preoperative urinary dysfunctions were excluded by study. Other exclusion criteria were surgery of lower urinary tract and psychiatric disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Bladder Training During Post-operative Hospital Stay After Radical Hysterectomy in Patients: a Randomized Trial
The objective of the study is to evaluate the impact and the outcome of bladder training during post-operative hospital stay after radical hysterectomy, mainly after neoadjuvant concurrent chemo-radiation therapy for locally advanced cervical cancer.
- Conditions
- Uterine Cervical Neoplasms
- Being tested
- bladder training, No bladder training
- Keywords
- bladder training, radical hysterectomy,gynaecologic cancer
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bladder trainingDevice
vescical catheter
No bladder trainingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Bladder training group | Experimental | The patients of this group were submitted to passive vesical gymnastic during the second and third postoperative days, throughout the closure of the catheter for 3 h and open it for 15 min all day long. Receives: Device: bladder training |
| No bladder training group | Experimental | The patients of this group were not submitted to passive vesical gymnastic during the second and third postoperative days Receives: Procedure: No bladder training |
What is being measured
The primary outcome is the main question the study is designed to answer.
clean intermittent self-catheterization
necessity and duration of clean intermittent self-catheterization after three days
Measured: three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startApr 2009
- Primary completionNov 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Giovanni Scambia, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907646
- Sponsor's protocol ID
- 12345
- Status last verified
- Jul 2013
- First submitted
- 18 Aug 2012
- Last updated
- 25 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Bladder Training During Post-operative Hospital Stay After Radical Hysterectomy in Patients: a Randomized Trial
- ClinicalTrials.gov ID
- NCT01907646
- Acronym / sponsor ID
- 12345
- Conditions
- Uterine Cervical Neoplasms
- Keywords
- bladder training, radical hysterectomy,gynaecologic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 25 Jul 2013 (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.
The objective of the study is to evaluate the impact and the outcome of bladder training during post-operative hospital stay after radical hysterectomy, mainly after neoadjuvant concurrent chemo-radiation therapy for locally advanced cervical cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bladder training group | Experimental | Device: bladder trainingThe patients of this group were submitted to passive vesical gymnastic during the second and third postoperative days, throughout the closure of the catheter for 3 h and open it for 15 min all day long. |
| No bladder training group | Experimental | Procedure: No bladder trainingThe patients of this group were not submitted to passive vesical gymnastic during the second and third postoperative days |
Who may qualify
- Ages
- 27 to 81 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women who underwent Querleu-Morrow class B2 and class C1 RH were enrolled in this randomized prospective study.
Key exclusion criteria (1 listed)
- -All the patients with preoperative urinary dysfunctions were excluded by study. Other exclusion criteria were surgery of lower urinary tract and psychiatric disease.
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 |
|---|---|---|
| bladder trainingvescical catheter | Device | Bladder training group |
| No bladder training | Procedure or surgery | No bladder training group |
Primary outcome
clean intermittent self-catheterization
Time frame: three days
necessity and duration of clean intermittent self-catheterization after three days
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 25 Jul 2013.
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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 2 study testing bladder training and No bladder training in people with Uterine Cervical Neoplasms, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 1 inclusion and 1 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 25 Jul 2013. 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 Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
clean intermittent self-catheterization (time frame: three days). 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 25 Jul 2013; AzTrials last refreshed its copy on 7 Nov 2026.