Impact of Nerve-sparing Radical Hysterectomy on Patients' Urinary Dynamics

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Nerve-sparing Radical Hysterectomy on Patients' Urinary Dynamics: a Randomized Controlled Trial

Conditions
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Cervical Cancer, Urinary Retention

Intervention / Treatment
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* Procedure: BiClamp group
* Procedure: water jet group


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: BiClamp group<br>BiClamp forcep (BiClamp® forcep, ERBE Elektromedizin, GmbH, Tuebingen, Germany) is used to dissect inferior hypogastric plexus | Procedure: BiClamp group<br>* electric energy<br>* Other names: BiClamp® forcep, ERBE Elektromedizin;|
| Active Comparator: water jet group<br>water jet (ERBEJET®2, ERBE Elektromedizin, GmbH, Tuebingen, Germany) is used to dissect inferior hypogastric plexus | Procedure: water jet group<br>* water jet energy<br>* Other names: ERBEJET®2, ERBE Elektromedizin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful rate of removing urinary catheter | successful rate (%) of removing urinary catheter assessed by residual urine volume less than 100 ml | 14th day after nerve-sparing radical hysterectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary dynamics parameters determined by urodynamics apparatus: bladder capacity and sensation | bladder capacity and sensation in ml | four months after nerve-sparing radical hysterectomy | 
| urinary dynamics parameters determined by urodynamics apparatus: residual urine volume | residual urine volume in ml | four months after nerve-sparing radical hysterectomy | 
| urinary dynamics parameters determined by urodynamics apparatus: urine flow rate | urine flow rate in ml/s | four months after nerve-sparing radical hysterectomy | 
| urinary dynamics parameters determined by urodynamics apparatus: bladder pressure | bladder pressure in cmH2O | four months after nerve-sparing radical hysterectomy | 
| urinary dynamics parameters determined by urodynamics apparatus: detrusor pressure | detrusor pressure in cmH2O | four months after nerve-sparing radical hysterectomy | 
| urinary dynamics parameters determined by urodynamics apparatus: bladder compliance | bladder compliance in ml/cmH2O | four months after nerve-sparing radical hysterectomy | 
| survival outcomes: ovarall survival | overall survival in months | two years after nerve-sparing radical hysterectomy | 
| survival outcomes: progression-free survival | progression-free survival in months | two years after nerve-sparing radical hysterectomy |