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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03020238
• Other study ID #: PUMCH-OBGYN-2013
• Status: Completed
• Phase: N/A
• First received: January 11, 2017
• Last updated: January 12, 2017
• Start date: January 2013
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Urinary Retention
• Uterine Cervical Neoplasms

Intervention

Procedure:
• BiClamp group
electric energy
• water jet group
water jet energy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

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