NCT01907646

Brief Summary

The objective of the study is to evaluate the impact and the outcome of bladder training during post-operative hospital stay after radical hysterectomy, mainly after neoadjuvant concurrent chemo-radiation therapy for locally advanced cervical cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2012

Completed
11 months until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed
Last Updated

July 25, 2013

Status Verified

July 1, 2013

Enrollment Period

2.6 years

First QC Date

August 18, 2012

Last Update Submit

July 24, 2013

Conditions

Uterine Cervical Neoplasms

Keywords

bladder training, radical hysterectomy,gynaecologic cancer

Outcome Measures

Primary Outcomes (1)

  • clean intermittent self-catheterization

    necessity and duration of clean intermittent self-catheterization after three days

    three days

Study Arms (2)

Bladder training group

EXPERIMENTAL

The patients of this group were submitted to passive vesical gymnastic during the second and third postoperative days, throughout the closure of the catheter for 3 h and open it for 15 min all day long.

Device: bladder training

No bladder training group

EXPERIMENTAL

The patients of this group were not submitted to passive vesical gymnastic during the second and third postoperative days

Procedure: No bladder training

Interventions

bladder trainingDEVICE

vescical catheter

Bladder training group
No bladder trainingPROCEDURE
No bladder training group

Eligibility Criteria

Age27 Years - 81 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Women who underwent Querleu-Morrow class B2 and class C1 RH were enrolled in this randomized prospective study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of the Sacred Heart

Rome, Italy, 00168, Italy

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 18, 2012

First Posted

July 25, 2013

Study Start

April 1, 2009

Primary Completion

November 1, 2011

Study Completion

August 1, 2012

Last Updated

July 25, 2013

Record last verified: 2013-07

Locations

IT(1)