Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

Urinary Retention

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urination Disorders

Urologic Diseases

Male Urogenital Diseases

BiClamp forcep (BiClamp® forcep, ERBE Elektromedizin, GmbH, Tuebingen, Germany) is used to dissect inferior hypogastric plexus

water jet (ERBEJET®2, ERBE Elektromedizin, GmbH, Tuebingen, Germany) is used to dissect inferior hypogastric plexus

BiClamp group

water jet group

Wu Ming, MD

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.

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

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

IPD will be shared with authorised researchers via online database.

successful rate (%) of removing urinary catheter assessed by residual urine volume less than 100 ml

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact of Nerve-sparing Radical Hysterectomy on Patients' Urinary Dynamics	NCT03020238	Cervical Cancer Urinary Retenti...	BiClamp group water jet group	-	Peking Union Medical College Hospital
Impact of Nerve-sparing Radical Hysterectomy on Patients' Urinary Dynamics	NCT03020238	Cervical Cancer Urinary Retenti...	BiClamp group water jet group	-	Peking Union Medical College Hospital
Impact of Nerve-sparing Radical Hysterectomy on Patients' Urinary Dynamics	NCT03020238	Cervical Cancer Urinary Retenti...	BiClamp group water jet group	-	Peking Union Medical College Hospital

Spots Global Cancer Trial Database for water jet group