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

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.

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 Overview

• Status: Completed
• Conditions: Cervical Cancer; Urinary Retention
• Intervention / Treatment: Procedure: BiClamp group; Procedure: water jet group

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Wu Ming, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: January 11, 2017
• First Submitted That Met QC Criteria: January 12, 2017
• First Posted (Estimate): January 13, 2017

Study Record Updates

• Last Update Posted (Estimate): January 13, 2017
• Last Update Submitted That Met QC Criteria: January 12, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Urinary Retention
• Other Study ID Numbers: PUMCH-OBGYN-2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: IPD will be shared with authorised researchers via online database.