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Evaluating the Change of Overactive Bladder Symptoms in Women Post Pubovaginal Sling Procedure for Stress Incontinence

NCT ID: NCT01194999

Last Updated: 2012-09-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-06-30

Brief Summary

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Pubovaginal sling (PVS) procedures are designed to curtail bladder leakage brought about by strenuous events such as child birth. A common purported side effect of PVS is urgency, the feeling of a compelling need to void with little warning. Other overactive bladder (OAB) adverse effects that some claim to develop post-op include further leakage (incontinence), frequency and nocturia (night time leakage). Anecdotal evidence from our clinic however, suggests that such de novo OAB symptoms are rarely induced by PVS, and may in fact be alleviated by said procedure. It is our aim to investigate this relationship in our clinic.

As a prospective member of this study, you will be asked to complete five surveys. The first survey will be administered prior to your pubovaginal sling. This will be used to establish your baseline experience of OAB. Over the course of the next year, you will be asked to complete the four remaining surveys at regularly scheduled check-ups.

Detailed Description

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Conditions

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Urinary Bladder, Overactive

Keywords

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OAB Urinary Bladder, Overactive Overactive Bladder Syndrome VESIcare Urgency Nocturia Frequency Urge Urinary Incontinence UUI Pubovaginal Sling PVS Incontinence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pubovaginal sling procedure

Patients undergoing pubovaginal slings for stress urinary incontinence.

Group Type EXPERIMENTAL

Pubovaginal sling procedure

Intervention Type DEVICE

The procedure involves placing a band of sling material directly under the bladder neck (ie, proximal urethra) or mid-urethra, which acts as a physical support to prevent bladder neck and urethral descent during physical activity. The sling also may augment the resting urethral closure pressure with increases in intra-abdominal pressure.

Interventions

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Pubovaginal sling procedure

The procedure involves placing a band of sling material directly under the bladder neck (ie, proximal urethra) or mid-urethra, which acts as a physical support to prevent bladder neck and urethral descent during physical activity. The sling also may augment the resting urethral closure pressure with increases in intra-abdominal pressure.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Post-pubovaginal sling patient.
* Complete agreement and signing of Informed Consent Form.

Exclusion Criteria

* Currently taking antimuscarinics or α1 blockers.
* Patients with urinary retention, dependent on dialysis, gastroparesis or narrow angle glaucoma.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Canada, Inc.

INDUSTRY

Sponsor Role collaborator

Barrie Urology Associates

OTHER

Sponsor Role lead

Responsible Party

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Dr. Joseph Zadra

Chief of Urology, RVH

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph A Zadra, MD CM FRCSC

Role: PRINCIPAL_INVESTIGATOR

Barrie Urology Associates - The Male/Female Health and Research Centre

Locations

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Barrie Urology Associates - The Male/Female Health and Research Centre

Barrie, Ontario, Canada

Site Status

Countries

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Canada

References

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Toledo LG, Korkes F, Romero FR, Fernandes RC, Oliveira C, Perez MD. Bladder outlet obstruction after pubovaginal fascial sling. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Feb;20(2):201-5. doi: 10.1007/s00192-008-0759-8. Epub 2008 Nov 12.

Reference Type BACKGROUND
PMID: 19002645 (View on PubMed)

Koch YK, Zimmern P. A critical overview of the evidence base for the contemporary surgical management of stress incontinence. Curr Opin Urol. 2008 Jul;18(4):370-6. doi: 10.1097/MOU.0b013e3282fdf8d5.

Reference Type BACKGROUND
PMID: 18520757 (View on PubMed)

Chapple CR, Fianu-Jonsson A, Indig M, Khullar V, Rosa J, Scarpa RM, Mistry A, Wright DM, Bolodeoku J; STAR study group. Treatment outcomes in the STAR study: a subanalysis of solifenacin 5 mg and tolterodine ER 4 mg. Eur Urol. 2007 Oct;52(4):1195-203. doi: 10.1016/j.eururo.2007.05.027. Epub 2007 Jun 6.

Reference Type BACKGROUND
PMID: 17574730 (View on PubMed)

Toglia MR, Ostergard DR, Appell RA, Andoh M, Fakhoury A, Hussain IF. Solifenacin for overactive bladder: secondary analysis of data from VENUS based on baseline continence status. Int Urogynecol J. 2010 Jul;21(7):847-54. doi: 10.1007/s00192-010-1120-6. Epub 2010 Mar 26.

Reference Type BACKGROUND
PMID: 20339833 (View on PubMed)

Karram MM, Toglia MR, Serels SR, Andoh M, Fakhoury A, Forero-Schwanhaeuser S. Treatment with solifenacin increases warning time and improves symptoms of overactive bladder: results from VENUS, a randomized, double-blind, placebo-controlled trial. Urology. 2009 Jan;73(1):14-8. doi: 10.1016/j.urology.2008.08.485. Epub 2008 Nov 8.

Reference Type BACKGROUND
PMID: 18995887 (View on PubMed)

Other Identifiers

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ARC-2010-04

Identifier Type: -

Identifier Source: org_study_id