Back to resultsRole of Bladder Training During Post-operative Hospital Stay After Radical Hysterectomy in Patients
Primary Purpose
Uterine Cervical Neoplasms
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
bladder training
No bladder training
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Cervical Neoplasms focused on measuring bladder training, radical hysterectomy,gynaecologic cancer
Eligibility Criteria
Inclusion Criteria:
- Women who underwent Querleu-Morrow class B2 and class C1 RH were enrolled in this randomized prospective study.
Exclusion Criteria:
-All the patients with preoperative urinary dysfunctions were excluded by study. Other exclusion criteria were surgery of lower urinary tract and psychiatric disease.
Sites / Locations
- Catholic University of the Sacred Heart
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Bladder training group
No bladder training group
Arm Description
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.
The patients of this group were not submitted to passive vesical gymnastic during the second and third postoperative days
Outcomes
Primary Outcome Measures
clean intermittent self-catheterization
necessity and duration of clean intermittent self-catheterization after three days
Secondary Outcome Measures
Full Information
NCT ID
NCT01907646
First Posted
August 18, 2012
Last Updated
July 24, 2013
Sponsor
Catholic University of the Sacred Heart
1. Study Identification
Unique Protocol Identification Number
NCT01907646
Brief Title
Role of Bladder Training During Post-operative Hospital Stay After Radical Hysterectomy in Patients
Official Title
Role of Bladder Training During Post-operative Hospital Stay After Radical Hysterectomy in Patients: a Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasms
Keywords
bladder training, radical hysterectomy,gynaecologic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bladder training group
Arm Type
Experimental
Arm Description
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.
Arm Title
No bladder training group
Arm Type
Experimental
Arm Description
The patients of this group were not submitted to passive vesical gymnastic during the second and third postoperative days
Intervention Type
Device
Intervention Name(s)
bladder training
Intervention Description
vescical catheter
Intervention Type
Procedure
Intervention Name(s)
No bladder training
Primary Outcome Measure Information:
Title
clean intermittent self-catheterization
Description
necessity and duration of clean intermittent self-catheterization after three days
Time Frame
three days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
27 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Women who underwent Querleu-Morrow class B2 and class C1 RH were enrolled in this randomized prospective study.
Exclusion Criteria:
-All the patients with preoperative urinary dysfunctions were excluded by study. Other exclusion criteria were surgery of lower urinary tract and psychiatric disease.
Facility Information:
Facility Name
Catholic University of the Sacred Heart
City
Rome
ZIP/Postal Code
00168
Country
Italy
12. IPD Sharing Statement
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Role of Bladder Training During Post-operative Hospital Stay After Radical Hysterectomy in Patients
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