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

C

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

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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