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

Phase 2

Completed

• Conditions: Uterine Cervical Neoplasms
• Interventions: Device: bladder training; Procedure: No bladder training

• Registration Number: NCT01907646
• Lead Sponsor: Catholic University of the Sacred Heart

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2011-11
• Study Completion: 2012-08
• Study First Submitted: 2012-08-18
• Status Verified: 2013-07
• Study First Submitted QC: 2013-07-24
• Last Update Submitted: 2013-07-24
• Study First Posted: 2013-07-25
• Last Update Posted: 2013-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 111

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bladder training group	bladder training	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.
No bladder training group	No bladder training	The patients of this group were not submitted to passive vesical gymnastic during the second and third postoperative days

Primary Outcome Measures

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

Trial Locations

Locations (1)

Catholic University of the Sacred Heart; 🇮🇹 Rome, Italy