Post-operative Voiding Dysfunction: the Preferred Method for Catheterization

NCT01597544 | Unknown DMC

• 1 other identifier: 241110
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Voiding dysfunction; bladder catheter; prolapse surgery; patient satisfaction

Outcome Measures

Primary Outcomes (2)

• Part 1: Patient catheter preference

  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).

  24 months

• Part 2: patient satisfaction with regard to timing of CISC teaching.

  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.

  24 months

Secondary Outcomes (4)

• Patient satisfaction with catheter choice

  24 months

• Incidence of post-operative voiding dysfunction after prolapse surgery

  24 months

• Bladder function after catheter use

  24 months

• Incidence of bacteruria/urinary tract infection after catheter use

  24 months

Study Arms (2)

CISC instruction post-operatively

NO INTERVENTION

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.

CISC instruction pre-operatively

ACTIVE COMPARATOR

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

Interventions

CISC instruction pre-operatively PROCEDURE

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.

CISC instruction pre-operatively

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital, University of Toronto

Toronto, Ontario, M5C 1R6, Canada

Location

Related Publications (25)

• Hakvoort RA, Dijkgraaf MG, Burger MP, Emanuel MH, Roovers JP. Predicting short-term urinary retention after vaginal prolapse surgery. Neurourol Urodyn. 2009;28(3):225-8. doi: 10.1002/nau.20636.

  PMID: 19130599 BACKGROUND

• Schiotz HA. Comparison of 1 and 3 days' transurethral Foley catheterization after retropubic incontinence surgery. Int Urogynecol J Pelvic Floor Dysfunct. 1996;7(2):98-101. doi: 10.1007/BF01902381.

  PMID: 8798095 BACKGROUND

• Glavind K, Morup L, Madsen H, Glavind J. A prospective, randomised, controlled trial comparing 3 hour and 24 hour postoperative removal of bladder catheter and vaginal pack following vaginal prolapse surgery. Acta Obstet Gynecol Scand. 2007;86(9):1122-5. doi: 10.1080/00016340701505317.

  PMID: 17712655 BACKGROUND

• Hakvoort RA, Elberink R, Vollebregt A, Ploeg T, Emanuel MH. How long should urinary bladder catheterisation be continued after vaginal prolapse surgery? A randomised controlled trial comparing short term versus long term catheterisation after vaginal prolapse surgery. BJOG. 2004 Aug;111(8):828-30. doi: 10.1111/j.1471-0528.2004.00181.x.

  PMID: 15270931 BACKGROUND

• Van Der Steen A, Detollenaere R, Den Boon J, Van Eijndhoven H. One-day versus 3-day suprapubic catheterization after vaginal prolapse surgery: a prospective randomized trial. Int Urogynecol J. 2011 May;22(5):563-7. doi: 10.1007/s00192-011-1358-7. Epub 2011 Mar 3.

  PMID: 21369817 BACKGROUND

• Alonzo-Sosa JE, Flores-Contreras JT, Paredes-Canul M. [Method for transurethral catheterization for 1-3 days for pelvic floor relaxation in the postoperative period]. Ginecol Obstet Mex. 1997 Nov;65:455-7. Spanish.

  PMID: 9441144 BACKGROUND

• Guzman S, Israel E, Puente R, Iglesias R, Rosa G, Ulloa C. [Handling of Foley catheter regarding urinary retention syndrome following vaginal surgery]. Rev Chil Obstet Ginecol. 1994;59(4):280-3. Spanish.

  PMID: 7659824 BACKGROUND

• Bidmead J, Cardozo L. Retropubic urethropexy (Burch colposuspension). Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(4):262-5. doi: 10.1007/s001920170050.

  PMID: 11569656 BACKGROUND

• Colombo M, Vitobello D, Proietti F, Milani R. Randomised comparison of Burch colposuspension versus anterior colporrhaphy in women with stress urinary incontinence and anterior vaginal wall prolapse. BJOG. 2000 Apr;107(4):544-51. doi: 10.1111/j.1471-0528.2000.tb13276.x.

  PMID: 10759276 BACKGROUND

• Kleeman S, Goldwasser S, Vassallo B, Karram M. Predicting postoperative voiding efficiency after operation for incontinence and prolapse. Am J Obstet Gynecol. 2002 Jul;187(1):49-52. doi: 10.1067/mob.2002.124841.

  PMID: 12114887 BACKGROUND

• Jannelli ML, Wu JM, Plunkett LW, Williams KS, Visco AG. A randomized controlled trial of clean intermittent self-catheterization versus suprapubic catheterization after urogynecologic surgery. Am J Obstet Gynecol. 2007 Jul;197(1):72.e1-4. doi: 10.1016/j.ajog.2007.02.043.

  PMID: 17618764 BACKGROUND

• Vierhout ME. Prolonged catheterization after vaginal prolapse surgery. Acta Obstet Gynecol Scand. 1998 Nov;77(10):997-9.

  PMID: 9849844 BACKGROUND

• Kringel U, Reimer T, Tomczak S, Green S, Kundt G, Gerber B. Postoperative infections due to bladder catheters after anterior colporrhaphy: a prospective, randomized three-arm study. Int Urogynecol J. 2010 Dec;21(12):1499-504. doi: 10.1007/s00192-010-1221-2. Epub 2010 Aug 4.

  PMID: 20683580 BACKGROUND

• Dobbs SP, Jackson SR, Wilson AM, Maplethorpe RP, Hammond RH. A prospective, randomized trial comparing continuous bladder drainage with catheterization at abdominal hysterectomy. Br J Urol. 1997 Oct;80(4):554-6. doi: 10.1046/j.1464-410x.1997.t01-1-00376.x.

  PMID: 9352691 BACKGROUND

• Woodward S, Rew M. Patients' quality of life and clean intermittent self-catheterization. Br J Nurs. 2003 Oct 9-22;12(18):1066-74. doi: 10.12968/bjon.2003.12.18.11782.

  PMID: 14581839 BACKGROUND

• Maynard FM, Diokno AC. Urinary infection and complications during clean intermittent catheterization following spinal cord injury. J Urol. 1984 Nov;132(5):943-6. doi: 10.1016/s0022-5347(17)49959-9.

  PMID: 6333518 BACKGROUND

• Kessler TM, Ryu G, Burkhard FC. Clean intermittent self-catheterization: a burden for the patient? Neurourol Urodyn. 2009;28(1):18-21. doi: 10.1002/nau.20610.

  PMID: 18726939 BACKGROUND

• Hakvoort RA, Thijs SD, Bouwmeester FW, Broekman AM, Ruhe IM, Vernooij MM, Burger MP, Emanuel MH, Roovers JP. Comparing clean intermittent catheterisation and transurethral indwelling catheterisation for incomplete voiding after vaginal prolapse surgery: a multicentre randomised trial. BJOG. 2011 Aug;118(9):1055-60. doi: 10.1111/j.1471-0528.2011.02935.x. Epub 2011 Apr 11.

  PMID: 21481147 BACKGROUND

• Scott BM. Clinical and cost effectiveness of urethral catheterisation: a review. J Perioper Pract. 2010 Jul;20(7):235-40. doi: 10.1177/175045891002000701.

  PMID: 20701200 BACKGROUND

• Niel-Weise BS, van den Broek PJ. Urinary catheter policies for short-term bladder drainage in adults. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD004203. doi: 10.1002/14651858.CD004203.pub2.

  PMID: 16034924 BACKGROUND

• McPhail MJ, Abu-Hilal M, Johnson CD. A meta-analysis comparing suprapubic and transurethral catheterization for bladder drainage after abdominal surgery. Br J Surg. 2006 Sep;93(9):1038-44. doi: 10.1002/bjs.5424.

  PMID: 16804872 BACKGROUND

• Park HC, Son JH, Jang SH. Rethinking suprapubic cystostomy in voiding dysfunction: new trial with timed drainage. Korean J Urol. 2010 Dec;51(12):847-52. doi: 10.4111/kju.2010.51.12.847. Epub 2010 Dec 21.

  PMID: 21221205 BACKGROUND

• Dunn TS, Figge J, Wolf D. A comparison of outcomes of transurethral versus suprapubic catheterization after Burch cystourethropexy. Int Urogynecol J Pelvic Floor Dysfunct. 2005 Jan-Feb;16(1):60-2; discussion 62. doi: 10.1007/s00192-004-1209-x. Epub 2004 Jul 28.

  PMID: 15647964 BACKGROUND

• Stekkinger E, van der Linden PJ. A comparison of suprapubic and transurethral catheterization on postoperative urinary retention after vaginal prolapse repair: a randomized controlled trial. Gynecol Obstet Invest. 2011;72(2):109-16. doi: 10.1159/000323827. Epub 2011 Feb 18.

  PMID: 21335940 BACKGROUND

• Niel-Weise BS, van den Broek PJ. Antibiotic policies for short-term catheter bladder drainage in adults. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD005428. doi: 10.1002/14651858.CD005428.

  PMID: 16034973 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Colleen D McDermott, MD, FRCSC

  St. Michael's Hospital, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2012
• First Posted: May 14, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 21, 2017

Record last verified: 2016-07

Locations

CA (1)