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Post-operative Voiding Dysfunction: the Preferred Method for Catheterization

NCT01597544 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2017-07-21

No results posted yet for this study

Summary

This study is divided into two parts. The first part is a prospective observational study of patients undergoing pelvic organ prolapse (POP) surgery. The goal is to determine patient preference between 3 different methods of bladder drainage in case of post-operative voiding dysfunction (POVD): transurethral indwelling catheterization (TIC), clean intermittent self-catheterization (CISC), and suprapubic tube (SPT). The second part of the study will be for those that choose CISC as their preferred method, whereby these patients will be randomized to receive CISC instruction either pre- or post-operatively to determine whether there is a difference in overall patient satisfaction based on timing of teaching.

The investigators hypothesize that patients that receive informed consent pre-operatively will favour the use of SPT over TIC and CISC to manage potential POVD.

Among those patients who opted for CISC in management of their post-operative voiding dysfunction, patients that are taught how to perform CISC pre-operatively in the clinic will have a higher level of satisfaction compared to those that are taught post-operatively in the hospital.

Conditions

  • Voiding Dysfunction After Pelvic Organ Prolapse Surgery

Interventions

PROCEDURE

CISC instruction pre-operatively

Patients allocated to the pre-operative CISC teaching group will be taught how to perform CISC by one of urogynecology nurses working at the Women's Health Care Centre. Patients will be allowed to practice until they feel comfortable with the technique. This should take approximately 30 minutes. The session will take place on the day of their pre-operative medical appointment (PAF), which normally occurs less than a month before the surgery. If a patient is not seen in PAF or is seen more than a month before her surgery, a separate appointment for CISC teaching during the month preceding the surgery will be organized. Post-operatively, a nurse from the hospital gynecology unit will review the technique to make sure the patient is still comfortable with performing CISC.

Sponsors & Collaborators

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Colleen D McDermott, MD, FRCSC · St. Michael's Hospital, University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01597544 on ClinicalTrials.gov