Post-operative Voiding Dysfunction: the Preferred Method for Catheterization

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by St. Michael's Hospital, Toronto.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01597544
First received: May 10, 2012
Last updated: May 11, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Voiding Dysfunction After Pelvic Organ Prolapse Surgery
Procedure: CISC instruction pre-operatively

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Post-operative Voiding Dysfunction: the Preferred Method for Catheterization

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Part 1: Patient catheter preference [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    For the first part of the study, the primary outcome is determining patient preference for method of bladder drainage for potential post-operative voiding dysfunction when asked pre-operatively. They will be given the options of either transurethral indwelling catheter (TIC), clean intermittent self catheterization (CISC), or suprapubic tube (SPT).

  • Part 2: patient satisfaction with regard to timing of CISC teaching. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    For the second part of the study, the primary outcome measure is the difference in patient satisfaction levels between those that had pre-operative CISC teaching compared with those that had the standard post-operative CISC teaching.


Secondary Outcome Measures:
  • Patient satisfaction with catheter choice [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    This will be assessed using a visual analog scale based on a previously published questionnaire. This questionnaire will be administered on the day of discharge, on post-operative day seven, and six weeks after surgery. This will be compared between the three different catheter groups.

  • Incidence of post-operative voiding dysfunction after prolapse surgery [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    We will determine the actual number of patients that required catheter use to manage acute voiding dysfunction after prolapse surgery.

  • Bladder function after catheter use [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    We will assess bladder function in those patients that required bladder catheterization to manage post-operative voiding dysfunction by performing uroflowmetry and post-void residual measurements at one and six weeks after surgery. This will be compared between the three different catheter groups.

  • Incidence of bacteruria/urinary tract infection after catheter use [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    We will assess the incidence of bacteruria/urinary tract infection in those patients that required bladder catheterization to manage post-operative voiding dysfunction by performing uroflowmetry and post-void residual measurements at one and six weeks after surgery. This will be compared between the different catheter groups.


Estimated Enrollment: 150
Study Start Date: July 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: CISC instruction post-operatively
For those patients that are randomized to CISC instruction before surgery, instruction will begin on post-operative day one. One of the nurses from the hospital gynecology unit will teach and supervise the patients until they feel comfortable with the technique or until catheterization is no longer required (e.g. when the patient passes her voiding trial on two separate occasions). This is the protocol currently in use at our institution.
Active Comparator: 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.
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All pre-operative patients seen at the St. Michael's Hospital Women's Health Care Centre and consented for a POP surgery will be eligible to participate in the first part of this study.
  • All patients undergoing POP surgery that choose CISC as their preferred method of bladder drainage will then be eligible for the second part of the study.
  • Additional inclusion criteria for both parts of the study include: female gender, greater than 18 years of age, and able to read and write in the English language

Exclusion Criteria:

  • Significant cognitive impairment, a history of neurogenic voiding dysfunction, a history of prior catheter use in the outpatient setting, as well as any patients undergoing outpatient surgery or surgery that only includes the posterior vaginal compartment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597544

Contacts
Contact: Colleen D McDermott, MD, FRCSC 416-864-6060 ext 6623 mcdermottc@smh.ca
Contact: Marianne Boutet, MD, FRCSC 416-864-6060 ext 5431 boutetm@smh.ca

Locations
Canada, Ontario
St. Michael's Hospital, University of Toronto Not yet recruiting
Toronto, Ontario, Canada, M5C 1R6
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Colleen D McDermott, MD, FRCSC St. Michael's Hospital, University of Toronto
  More Information

Publications:

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01597544     History of Changes
Other Study ID Numbers: 241110
Study First Received: May 10, 2012
Last Updated: May 11, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by St. Michael's Hospital, Toronto:
Voiding dysfunction
bladder catheter
prolapse surgery
patient satisfaction

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 30, 2014