NCT02083614

Brief Summary

The effect of clamping the indwelling urethral catheter before removal is an unsettled issue in clinical practice. No studies have done before in the patients with gynecologic cancers who received radical hysterectomy. We hypothesized that clamping the catheter would decrease the rate of recatheterization. In addition, the feeling of urination during clamping is correlated with lower rate of recatheterization after removal.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

March 11, 2014

Status Verified

March 1, 2014

Enrollment Period

1 year

First QC Date

March 8, 2014

Last Update Submit

March 8, 2014

Conditions

Gynecologic Cancer

Outcome Measures

Primary Outcomes (1)

  • rate of recatheterization

    12 months

Study Arms (2)

clamping

EXPERIMENTAL

to clamp or release the catheter for 2 days before removal

Procedure: to clamp or release the catheter for 2 days before removal

no clamping

NO INTERVENTION

Interventions

to clamp or release the catheter for 2 days before removalPROCEDURE
clamping

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients receiving Piver III radical hysterectomy
  • catheterization over 7 days

You may not qualify if:

  • catheterization shorter than 7 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fulan Wang

Chongqing, 400016, China

RECRUITING

Related Publications (1)

  • Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.

    PMID: 34184246DERIVED

Central Study Contacts

fulan wang

CONTACT

00862389011080wfl3076@163.com

ling zhao

CONTACT

00862389011006239648507@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

March 8, 2014

First Posted

March 11, 2014

Study Start

November 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2015

Last Updated

March 11, 2014

Record last verified: 2014-03

Locations

CN(1)