Specific Aims To determine if an incontinence pessary will improve condition-specific quality
of life for women with stress urinary incontinence (SUI) in the third trimester of pregnancy
and collect pilot data to inform sample size and feasibility for a larger randomized
controlled trial.
Background/Significance The prevalence of antenatal urinary incontinence (UI) in nulliparous
women is 30-40%; the prevalence increases with multiparity and prior vaginal delivery. Stress
urinary incontinence (SUI) and mixed urinary incontinence (MUI) are reported by 37% and 58%
of gravidas respectively. Fifty percent of all new UI in pregnancy is SUI. As pregnancy
progresses the prevalence of SUI increases from 8.3% to 36.9% in the third trimester. The
frequency, volume and severity of the UI worsens with increasing gestational age, resulting
in increasingly profound effects on women's daily life. These concerns are often
underreported and under recognized by clinicians. SUI in pregnancy is currently managed with
pelvic floor exercises, associated with incomplete symptom relief, suboptimal patient
adherence and limited evidence.
Incontinence pessaries can be a ring or a dish with an incontinence knob. These pessaries
decrease UI by providing compression and support to the urethra. Up to 63% of non-pregnant
women fitted with an incontinence pessary are satisfied with the treatment at 3 months; after
one year of use 50-59% of women remain satisfied and one third have "no bothersome SUI
symptoms". Pessaries are a low risk and effective option to manage UI. The use of
incontinence pessaries is supported for the treatment of SUI in non-pregnant women by the
Society of Obstetrics and Gynaecology of Canada.
Pessaries are safe in pregnancy and have been reported for the management of cervical
insufficiency, pelvic organ prolapse, and incarcerated uterus. While some believe pregnant
women are ideal candidates for incontinence pessaries, supporting evidence is required. There
are currently no obstetrical guidelines supporting pessary use for incontinence in pregnancy
despite pessaries being a low risk treatment option; clinicians are currently limited to
offering pelvic floor exercises for antepartum urinary incontinence. Pessaries are a safe and
effective management option for UI in pregnancy and they can be managed independently by the
patient.
Stress urinary incontinence represents a common concern in pregnancy and lacks evidence-based
treatment options. In this pilot trial, the investigators propose to quantify the effect of
incontinence pessaries on condition-specific quality of life and SUI symptoms in pregnant
women, and to determine rate of successful pessary fitting, treatment acceptability, sexual
function, patterns of adherence, discontinuation rate, adverse events and global impression
of improvement. Our trial will provide important evidence for a much-needed larger clinical
trial aiming to investigate incontinence pessaries as a treatment option for SUI in
pregnancy.
Methodology
Design: Pilot randomized controlled trial
Sample Size: The effect size of a pessary for the treatment of SUI in pregnancy is unknown. A
convenience sample of 60 women will be recruited, with 30 women randomized to the
intervention arm (incontinence pessary) and 30 to the control arm (usual care).
Primary objective of pilot trial: To evaluate the effect size of an antepartum incontinence
pessary on the condition-specific quality of life of women with SUI in pregnancy, in order to
inform sample size calculations for a larger randomized controlled trial.
Secondary objectives of pilot trial: To evaluate feasibility and methodological barriers for
a future randomized controlled trial.
Experimental Design:
The investigators propose a prospective randomized controlled pilot trial of women with
bothersome SUI in the third trimester of a healthy singleton pregnancy. A convenience sample
of 30 women per arm will be recruited from obstetrical clinics. Women between 26- 28weeks
gestational age who answer yes to the screening question "Do you have bothersome urinary
leakage when you cough, sneeze or walk during this pregnancy?" will be invited to participate
in our proposed study by their primary maternity provider. The study coordinator will screen
potential participants by phone to ensure they meet out inclusion and exclusion criteria and
have a minimal Pelvic Floor Distress Inventory (PFDI-20) score of 25 for the UDI-6 section,
to ensure bother from SUI. Informed consent will be obtained. Following recruitment, a
baseline assessment (PFDI, Pelvic Floor Inventory Questionnaire (PFIQ), Female Sexual
Function Inventory (FSFI) and a bladder diary) and collection of demographic data will be
completed. These questionnaires will be emailed to participants. Participants will then be
randomized to the control or treatment group. The control group will continue with standard
obstetrical care while an incontinence pessary will be fitted for women in the treatment
group by an experienced nurse incontinence advisor at our pessary clinic.
Following randomization all participants will be screened every two weeks from 28 weeks
gestational age with the interim questionnaire. They will receive a biweekly phone call from
either the nurse continence advisor or the urogynecology fellow. For the treatment arm this
call will include their obstetric health, pessary tolerance and any adverse events. Women in
the control group will be asked the interim obstetrical questions only. This will continue
until delivery, pessary discontinuation, or 36 weeks gestational age at which point the
patient will be discharged from the study. An exit interview will be completed and will
consist of a final review of the biweekly questions, the questionnaires (PFDI, PFIQ, FSFI and
a bladder diary), and the acceptability questionnaire for those participants using a pessary.
Participants using a pessary will be asked to remove it at the end of the study. The
investigators will also collect data on study feasibility including recruitment rate,
methodological barriers, and follow up.
Intervention:
After deemed appropriate for recruitment, participants will be randomized to the control or
intervention arm. Both groups will continue to receive routine antenatal care and will
receive a handout on pelvic floor exercises in pregnancy. Women in the intervention arm will
be fitted with an incontinence ring pessary by an incontinence nurse experienced in pessary
fitting. They will be taught pessary maintenance and encouraged to remove and insert the
pessary independently. Participants will receive a handout on pessary use, risks and
obstetrical indications to remove the pessary.
Data Analysis:
Descriptive statistics on demographic characteristics will be reported. Condition-specific
quality of life and distress scores will be compared between control and intervention arms
using regression analysis adjusted for baseline score. Depending on the distribution of the
data, linear, generalized linear or quantile regression will be used. The main analysis will
be an intention-to-treat analysis which will include all women followed to the end of study,
with sensitivity analysis being a per protocol analysis which excluded women who discontinued
pessary prematurely. Effect size and variance will be calculated and used for future sample
size calculations. Pessary fitting success rate, discontinuation rates, and adverse events
will be continuously monitored. The investigators aim to recruit 2-3 women per week with a
drop-out rate under 20%.