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

Catholic University of the Sacred Heart

Status and phase: Completed; Phase 2

Conditions: Uterine Cervical Neoplasms

Treatments: Procedure: No bladder training; Device: bladder training

Study type: Interventional

Funder types: Other

Identifiers

NCT01907646

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Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: Female

Ages: 27 to 81 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 2 patient groups

Bladder training group

Experimental group

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.

Treatment:

Device: bladder training

No bladder training group

Experimental group

Description:

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

Treatment:

Procedure: No bladder training