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

• Sponsor: Barrie Urology Associates (Other)
• Overall Status: Completed
• CT.gov ID: NCT01194999
• Collaborator: Astellas Pharma Canada, Inc. (Industry)
• Enrollment: 132
• Location: 1
• Arm: 1
• Duration (Months): 20
• Patients Per Site Per Month: 6.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Bladder, Overactive	Device: Pubovaginal sling procedure	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 132 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluating the Change of Overactive Bladder Symptoms in Women Post Pubovaginal Sling Procedure for Stress Incontinence
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pubovaginal sling procedure Patients undergoing pubovaginal slings for stress urinary incontinence.	Device: 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.

Outcome Measures

Primary Outcome Measures

1. Change in OAB Symptoms Post Pubovaginal Sling Operation [Baseline to final follow-up.]

   Measured through the administration of five overactive bladder questionnaires. Difference from baseline to follow-up evaluated using the Wilcoxon Signed Rank Test.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barrie Urology Associates - The Male/Female Health and Research Centre	Barrie	Ontario	Canada	L4M 7G1

Sponsors and Collaborators

• Barrie Urology Associates
• Astellas Pharma Canada, Inc.

Investigators

• Principal Investigator: Joseph A Zadra, MD CM FRCSC, Barrie Urology Associates - The Male/Female Health and Research Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Epub 2007 Jun 6.
• 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.
• 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. Review.
• 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.
• 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.

• Responsible Party: Dr. Joseph Zadra, Chief of Urology, RVH, Barrie Urology Associates
• ClinicalTrials.gov Identifier: NCT01194999
• Other Study ID Numbers: ARC-2010-04
• First Posted: Sep 3, 2010
• Last Update Posted: Sep 20, 2012
• Last Verified: Aug 1, 2012

• Keywords provided by Dr. Joseph Zadra, Chief of Urology, RVH, Barrie Urology Associates: OAB; Urinary Bladder, Overactive; Overactive Bladder Syndrome; VESIcare; Urgency; Nocturia; Frequency; Urge Urinary Incontinence; UUI; Pubovaginal Sling; PVS; Incontinence
• Additional relevant MeSH terms: Urinary Bladder, Overactive; Urinary Incontinence, Stress

Study Results

Participant Flow

Recruitment Details	Recruitment occurred over the course of one year (October 2010 - October 2011). Patients requiring pubovaginal sling procedures for stress incontinence were invited to participate if they possessed limited comorbidities.
Pre-assignment Detail	No significant pres-assignment measures were taken.

Arm/Group Title	Pubovaginal Sling Procedure
Arm/Group Description	Patients undergoing pubovaginal slings for stress urinary incontinence.
Period Title: Overall Study
STARTED	132
COMPLETED	115
NOT COMPLETED	17

Baseline Characteristics

Arm/Group Title	Pubovaginal Sling Procedure
Arm/Group Description	Patients undergoing pubovaginal slings for stress urinary incontinence.
Overall Participants	132
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	118 89.4%
>=65 years	14 10.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.35 (11.28)
Sex: Female, Male (Count of Participants)
Female	132 100%
Male	0 0%
Region of Enrollment (participants) [Number]
Canada	132 100%

Outcome Measures

1. Primary Outcome

Title	Change in OAB Symptoms Post Pubovaginal Sling Operation
Description	Measured through the administration of five overactive bladder questionnaires. Difference from baseline to follow-up evaluated using the Wilcoxon Signed Rank Test.
Time Frame	Baseline to final follow-up.

Outcome Measure Data

Analysis Population Description

All patients enrolled in the study were analyzed, except for those currently being treated with antimuscarinic therapy.

Arm/Group Title	Pubovaginal Sling Procedure
Arm/Group Description	Patients undergoing pubovaginal slings for stress urinary incontinence.
Measure Participants	88
Patients with improved OAB	63 47.7%
Patients with stable OAB	21 15.9%
Patients with worsening OAB	4 3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pubovaginal Sling Procedure
	Comments	Null hypothesis: No significant difference from baseline to final follow-up.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	Adverse event data was collected for the duration of the study.
Arm/Group Title	Pubovaginal Sling Procedure
Arm/Group Description	Patients undergoing pubovaginal slings for stress urinary incontinence.
All Cause Mortality
	Pubovaginal Sling Procedure
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Pubovaginal Sling Procedure
	Affected / at Risk (%)	# Events
Total	0/132 (0%)
Other (Not Including Serious) Adverse Events
	Pubovaginal Sling Procedure
	Affected / at Risk (%)	# Events
Total	0/132 (0%)

Limitations/Caveats

The V8 questionnaire used for patient surveying has been validated, but forms of such a nature present potential over and under reporting of symptoms. Loss to follow-up presents an issue, although we anticipate those lost experienced improvements.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.