Role of Bladder Training During Post-operative Hospital Stay After Radical Hysterectomy in Patients

Uterine Cervical Neoplasms Clinical Trial

Official title:

Role of Bladder Training During Post-operative Hospital Stay After Radical Hysterectomy in Patients: a Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01907646
• Other study ID #: 12345
• Status: Completed
• Phase: Phase 2
• First received: August 18, 2012
• Last updated: July 24, 2013
• Start date: April 2009
• Est. completion date: August 2012

Study information

• Verified date: July 2013
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: August 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 27 Years to 81 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Uterine Cervical Neoplasms

Intervention

Device:
• bladder training
vescical catheter

Procedure:
• No bladder training

Locations

Country	Name	City	State
Italy	Catholic University of the Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clean intermittent self-catheterization	necessity and duration of clean intermittent self-catheterization after three days	three days	Yes