Urinary Bladder, Overactive
Conditions
Keywords
OAB, Urinary Bladder, Overactive, Overactive Bladder Syndrome, VESIcare, Urgency, Nocturia, Frequency, Urge Urinary Incontinence, UUI, Pubovaginal Sling, PVS, Incontinence
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.
Interventions
DEVICEPubovaginal 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.
Sponsors
Astellas Pharma Canada, Inc.
Barrie Urology Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
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 details
No significant pres-assignment measures were taken.
Participants by arm
| Arm | Count |
|---|---|
| Pubovaginal Sling Procedure Patients undergoing pubovaginal slings for stress urinary incontinence. | 132 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 17 |
Baseline characteristics
| Characteristic | Pubovaginal Sling Procedure |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 14 Participants |
| Age, Categorical Between 18 and 65 years | 118 Participants |
| Age Continuous | 51.35 years STANDARD_DEVIATION 11.28 |
| Region of Enrollment Canada | 132 participants |
| Sex: Female, Male Female | 132 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 132 |
| serious Total, serious adverse events | 0 / 132 |
Outcome results
Primary
Change in OAB Symptoms Post Pubovaginal Sling Operation
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.
Population: All patients enrolled in the study were analyzed, except for those currently being treated with antimuscarinic therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pubovaginal Sling Procedure | Change in OAB Symptoms Post Pubovaginal Sling Operation | Patients with improved OAB | 63 participants |
| Pubovaginal Sling Procedure | Change in OAB Symptoms Post Pubovaginal Sling Operation | Patients with stable OAB | 21 participants |
| Pubovaginal Sling Procedure | Change in OAB Symptoms Post Pubovaginal Sling Operation | Patients with worsening OAB | 4 participants |
Comparison: Null hypothesis: No significant difference from baseline to final follow-up.p-value: 0.001Wilcoxon (Mann-Whitney)