Clinical trial NCT03020238: Impact of Nerve-sparing Radical Hysterectomy on Patients' Urinary Dynamics
Official title: Impact of Nerve-sparing Radical Hysterectomy on Patients' Urinary Dynamics: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Urinary Retention
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* FIGO stage IB
* ASA score 0-2

Exclusion Criteria:

* Radiotherapy or chemotherapy before surgeries
* ASA score \> 2
* With abnormal urinary dynamics before surgeries

Primary outcomes:
measure: successful rate of removing urinary catheter
timeFrame: 14th day after nerve-sparing radical hysterectomy
Secondary outcomes:
measure: urinary dynamics parameters determined by urodynamics apparatus: bladder capacity and sensation
timeFrame: four months after nerve-sparing radical hysterectomy
measure: urinary dynamics parameters determined by urodynamics apparatus: residual urine volume
timeFrame: four months after nerve-sparing radical hysterectomy
measure: urinary dynamics parameters determined by urodynamics apparatus: urine flow rate
timeFrame: four months after nerve-sparing radical hysterectomy
measure: urinary dynamics parameters determined by urodynamics apparatus: bladder pressure
timeFrame: four months after nerve-sparing radical hysterectomy
measure: urinary dynamics parameters determined by urodynamics apparatus: detrusor pressure
timeFrame: four months after nerve-sparing radical hysterectomy
measure: urinary dynamics parameters determined by urodynamics apparatus: bladder compliance
timeFrame: four months after nerve-sparing radical hysterectomy
measure: survival outcomes: ovarall survival
timeFrame: two years after nerve-sparing radical hysterectomy
measure: survival outcomes: progression-free survival
timeFrame: two years after nerve-sparing radical hysterectomy
Other outcomes:
Locations:
Study officials:
affiliation: Peking Union Medical College Hospital
name: Wu Ming, MD
role: PRINCIPAL_INVESTIGATOR
References: