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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03020238
Enrollment
120
Registered
2017-01-13
Start date
2013-01-31
Completion date
2017-01-31
Last updated
2017-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, Urinary Retention

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.

Interventions

PROCEDUREBiClamp group

electric energy

PROCEDUREwater jet group

water jet energy

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
successful rate of removing urinary catheter14th day after nerve-sparing radical hysterectomysuccessful rate (%) of removing urinary catheter assessed by residual urine volume less than 100 ml

Secondary

MeasureTime frameDescription
urinary dynamics parameters determined by urodynamics apparatus: residual urine volumefour months after nerve-sparing radical hysterectomyresidual urine volume in ml
urinary dynamics parameters determined by urodynamics apparatus: urine flow ratefour months after nerve-sparing radical hysterectomyurine flow rate in ml/s
urinary dynamics parameters determined by urodynamics apparatus: bladder pressurefour months after nerve-sparing radical hysterectomybladder pressure in cmH2O
urinary dynamics parameters determined by urodynamics apparatus: bladder capacity and sensationfour months after nerve-sparing radical hysterectomybladder capacity and sensation in ml
urinary dynamics parameters determined by urodynamics apparatus: bladder compliancefour months after nerve-sparing radical hysterectomybladder compliance in ml/cmH2O
survival outcomes: ovarall survivaltwo years after nerve-sparing radical hysterectomyoverall survival in months
survival outcomes: progression-free survivaltwo years after nerve-sparing radical hysterectomyprogression-free survival in months
urinary dynamics parameters determined by urodynamics apparatus: detrusor pressurefour months after nerve-sparing radical hysterectomydetrusor pressure in cmH2O

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026