Clinical trial NCT01194999: Evaluating the Change of Overactive Bladder Symptoms in Women Post Pubovaginal Sling Procedure for Stress Incontinence
Official title: Evaluating the Change of Overactive Bladder Symptoms in Women Post Pubovaginal Sling Procedure for Stress Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Bladder, Overactive
Keywords: OAB
Urinary Bladder, Overactive
Overactive Bladder Syndrome
VESIcare
Urgency
Nocturia
Frequency
Urge Urinary Incontinence
UUI
Pubovaginal Sling
PVS
Incontinence
Lead sponsor: Barrie Urology Associates
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Canada, Inc.
First posted: 2010-09-03
Enrollment: 132
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in OAB Symptoms Post Pubovaginal Sling Operation
timeFrame: Baseline to final follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Barrie
country: Canada
facility: Barrie Urology Associates - The Male/Female Health and Research Centre
state: Ontario
Study officials:
affiliation: Barrie Urology Associates - The Male/Female Health and Research Centre
name: Joseph A Zadra, MD CM FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.