Cervical CancerNCT03020238
Impact of Nerve-sparing Radical Hysterectomy on Patients' Urinary Dynamics
A study testing BiClamp group and water jet group in people with Cervical Cancer and Urinary Retention, run by Peking Union Medical College Hospital.
Trial summary
Background: Radical hysterectomy is an important therapy for early cervical cancer. Disfunction of urinary dynamics is the most common postoperative adverse effects, which had negative impact on patients' quality of life. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Cancer, Urinary Retention
- What is being tested?
- BiClamp group and water jet group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jan 2017
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- FIGO stage IB
- ASA score 0-2
Who cannot join
- Radiotherapy or chemotherapy before surgeries
- ASA score > 2
- With abnormal urinary dynamics before surgeries
About this study
Official title: Impact of Nerve-sparing Radical Hysterectomy on Patients' Urinary Dynamics: a Randomized Controlled Trial
Background: Radical hysterectomy is an important therapy for early cervical cancer. Disfunction of urinary dynamics is the most common postoperative adverse effects, which had negative impact on patients' quality of life. Nerve sparing radical hysterectomy (NSRH) could reserve inferior hypogastric plexus (IHP) innervating bladder, hence improving postoperative urinary dynamics. Furthermore impact of different energy instruments on urinary dynamic isn't clear.
Objectives: This study is to compare urinary dynamics before and after NSRH, and to analyze the difference between BiClamp forcep (BiClamp® forcep, ERBE Elektromedizin, GmbH, Tuebingen, Germany) and water jet (ERBEJET®2) about the effects of dissecting IHP.
Read more
Study population: Cervical cancer of FIGO IB stage, among which 120 cases are enrolled to randomly allocated to BiClamp group or water jet group.
Intervention: Patients accept NSRH which all will be accomplished by Professor Ming Wu.
Methods: All surgical patients are accessed via urinary dynamics before and four months after NSRH. On the 14th day after surgeries, urinary catheter will be removed and residual urine volume (RUV) will be measured. For patients of RUV > 100 ml, urinary catheter will be replaced.
Primary study endpoint: the successful rate of removing urinary catheter on the 14th day after NSRH.
Secondary study endpoint: urinary dynamics four months after NSRH.
- Conditions
- Cervical Cancer, Urinary Retention
- Being tested
- BiClamp group, water jet group
- Medical subject headings
- Uterine Cervical Neoplasms, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiClamp groupProcedure or surgery
Also called BiClamp® forcep, ERBE Elektromedizin
electric energy
water jet groupProcedure or surgery
Also called ERBEJET®2, ERBE Elektromedizin
water jet energy
| Study group | Role | What they receive |
|---|---|---|
| BiClamp group | Placebo comparator | BiClamp forcep (BiClamp® forcep, ERBE Elektromedizin, GmbH, Tuebingen, Germany) is used to dissect inferior hypogastric plexus Receives: Procedure: BiClamp group |
| water jet group | Active comparator | water jet (ERBEJET®2, ERBE Elektromedizin, GmbH, Tuebingen, Germany) is used to dissect inferior hypogastric plexus Receives: Procedure: water jet group |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful rate of removing urinary catheter
successful rate (%) of removing urinary catheter assessed by residual urine volume less than 100 ml
Measured: 14th day after nerve-sparing radical hysterectomy
Secondary outcomes (8)
urinary dynamics parameters determined by urodynamics apparatus: bladder capacity and sensation
bladder capacity and sensation in ml
Measured: four months after nerve-sparing radical hysterectomy
urinary dynamics parameters determined by urodynamics apparatus: residual urine volume
residual urine volume in ml
Measured: four months after nerve-sparing radical hysterectomy
urinary dynamics parameters determined by urodynamics apparatus: urine flow rate
urine flow rate in ml/s
Measured: four months after nerve-sparing radical hysterectomy
urinary dynamics parameters determined by urodynamics apparatus: bladder pressure
bladder pressure in cmH2O
Measured: four months after nerve-sparing radical hysterectomy
urinary dynamics parameters determined by urodynamics apparatus: detrusor pressure
detrusor pressure in cmH2O
Measured: four months after nerve-sparing radical hysterectomy
urinary dynamics parameters determined by urodynamics apparatus: bladder compliance
bladder compliance in ml/cmH2O
Measured: four months after nerve-sparing radical hysterectomy
survival outcomes: ovarall survival
overall survival in months
Measured: two years after nerve-sparing radical hysterectomy
survival outcomes: progression-free survival
progression-free survival in months
Measured: two years after nerve-sparing radical hysterectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startJan 2013
- Primary completionJan 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Li, Peking Union Medical College Hospital
- Investigators
- Wu Ming, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020238
- Sponsor's protocol ID
- PUMCH-OBGYN-2013
- Status last verified
- Jan 2017
- First submitted
- 11 Jan 2017
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: IPD will be shared with authorised researchers via online database.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nerve-sparing Radical Hysterectomy on Patients' Urinary Dynamics: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03020238
- Acronym / sponsor ID
- PUMCH-OBGYN-2013
- Conditions
- Cervical Cancer, Urinary Retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 13 Jan 2017 (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.
Background: Radical hysterectomy is an important therapy for early cervical cancer. Disfunction of urinary dynamics is the most common postoperative adverse effects, which had negative impact on patients' quality of life. Nerve sparing radical hysterectomy (NSRH) could reserve inferior hypogastric plexus (IHP) innervating bladder, hence improving postoperative urinary dynamics. Furthermore impact of different energy instruments on urinary dynamic isn't clear.
Objectives: This study is to compare urinary dynamics before and after NSRH, and to analyze the difference between BiClamp forcep (BiClamp® forcep, ERBE Elektromedizin, GmbH, Tuebingen, Germany) and water jet (ERBEJET®2) about the effects of dissecting IHP.
Study population: Cervical cancer of FIGO IB stage, among which 120 cases are enrolled to randomly allocated to BiClamp group or water jet group.
Intervention: Patients accept NSRH which all will be accomplished by Professor Ming Wu.
Methods: All surgical patients are accessed via urinary dynamics before and four months after NSRH. On the 14th day after surgeries, urinary catheter will be removed and residual urine volume (RUV) will be measured. For patients of RUV > 100 ml, urinary catheter will be replaced.
Primary study endpoint: the successful rate of removing urinary catheter on the 14th day after NSRH.
Secondary study endpoint: urinary dynamics four months after NSRH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BiClamp group | Placebo comparator | Procedure: BiClamp groupBiClamp forcep (BiClamp® forcep, ERBE Elektromedizin, GmbH, Tuebingen, Germany) is used to dissect inferior hypogastric plexus |
| water jet group | Active comparator | Procedure: water jet groupwater jet (ERBEJET®2, ERBE Elektromedizin, GmbH, Tuebingen, Germany) is used to dissect inferior hypogastric plexus |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- FIGO stage IB
- ASA score 0-2
Key exclusion criteria (3 listed)
- Radiotherapy or chemotherapy before surgeries
- ASA score > 2
- With abnormal urinary dynamics before surgeries
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 |
|---|---|---|
| BiClamp groupAlso: BiClamp® forcep, ERBE Elektromedizinelectric energy | Procedure or surgery | BiClamp group |
| water jet groupAlso: ERBEJET®2, ERBE Elektromedizinwater jet energy | Procedure or surgery | water jet group |
Primary outcome
successful rate of removing urinary catheter
Time frame: 14th day after nerve-sparing radical hysterectomy
successful rate (%) of removing urinary catheter assessed by residual urine volume less than 100 ml
8 secondary outcomes
urinary dynamics parameters determined by urodynamics apparatus: bladder capacity and sensation
Time frame: four months after nerve-sparing radical hysterectomy
urinary dynamics parameters determined by urodynamics apparatus: residual urine volume
Time frame: four months after nerve-sparing radical hysterectomy
urinary dynamics parameters determined by urodynamics apparatus: urine flow rate
Time frame: four months after nerve-sparing radical hysterectomy
urinary dynamics parameters determined by urodynamics apparatus: bladder pressure
Time frame: four months after nerve-sparing radical hysterectomy
urinary dynamics parameters determined by urodynamics apparatus: detrusor pressure
Time frame: four months after nerve-sparing radical hysterectomy
urinary dynamics parameters determined by urodynamics apparatus: bladder compliance
Time frame: four months after nerve-sparing radical hysterectomy
survival outcomes: ovarall survival
Time frame: two years after nerve-sparing radical hysterectomy
survival outcomes: progression-free survival
Time frame: two years after nerve-sparing radical hysterectomy
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 13 Jan 2017.
- Individual participant dataSharing planned: Yes. IPD will be shared with authorised researchers via online database.
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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.
Wu Ming, MD principal investigator
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A study testing BiClamp group and water jet group in people with Cervical Cancer and Urinary Retention, run by Peking Union Medical College Hospital.
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 2 inclusion and 3 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 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
successful rate of removing urinary catheter (time frame: 14th day after nerve-sparing radical hysterectomy). 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 13 Jan 2017.