A Randomized Trial: Can a Postpartum Pelvic Floor Education Workshop in a High-Risk Population Improve Pelvic Floor Symptoms?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Pelvic floor distress inventory
Study Overview
Brief Summary
After having a baby, there are some expected changes in pelvic floor function. However, tearing of the pelvic floor, having a large baby and needing a vacuum or forceps to deliver the baby put women at risk for having pelvic floor disorders. Our study aims to see if, in women who had a high risk for pelvic floor disorders, a pelvic floor education workshop four weeks after delivery can improve pelvic floor disorders compared to those that did not have a workshop.
Detailed Description
There is compelling evidence for the need for perineal education and care, especially in women who have recognized risk factors. For example, 30-50% of women who have a clinically recognized risk factor report anal incontinence, fecal urgency, dyspareunia and perineal pain. Despite this, a study found that less than 50% of women with anal incontinence voice those symptoms unless directly asked about them.
Some authors discuss how women may not share these symptoms with their care providers out of the belief that it is a "normal" effect of childbirth. A review of the literature shows that antenatal educational workshops can be an effective means to provide pregnant women with information regarding pelvic floor health, including how modes of delivery impact pelvic floor function. Similarly, antenatal pelvic floor workshops have been found to improve patients' knowledge on pelvic floor health, their practice of pelvic floor muscle exercises and their confidence with these exercises.
To our knowledge, there is no literature exploring the role of a postpartum pelvic floor workshop, on managing perineal and pelvic floor symptoms in women who are identified as being at higher risk of developing pelvic floor dysfunction. Our goal is to develop and assess such a workshop.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
No masking is possible due to the nature of the study.
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Postpartum (ie no more than 4 weeks postpartum at time of group allocation)
- •Vaginal delivery
- •Sustained one or more of the following insults to perineum/pelvic floor
- •Third or fourth degree laceration
- •Vacuum or forceps assisted vaginal delivery
- •Delivery of macrosomic infant ≥4000g)
Exclusion Criteria
- •Prior pelvic floor physiotherapy treatment
- •Prior surgical management for pelvic organ prolapse or incontinence
- •Unable to understand English
- •Caesarean delivery
- •Concerns for patient sensitivity - eg if team is aware of neonatal demise, neonate unwell in NICU etc
Arms & Interventions
Intervention
One-time in-person workshop with pelvic floor physiotherapist
Intervention: Pelvic floor workshop (Behavioral)
Control
Standard care
Outcomes
Primary Outcomes
Pelvic floor distress inventory
Time Frame: Differences between groups in the change in score from beginning of study to 12 months post-partum
Validated survey on symptoms of pelvic floor distress
Pelvic floor distress inventory
Time Frame: Differences between groups in the change in score from beginning of study to 3 months post-partum
Survey on symptoms of pelvic floor distress
Pelvic floor distress inventory
Time Frame: Differences between groups in the change in score from beginning of study to 6 months post-partum
Survey on symptoms of pelvic floor distress
Secondary Outcomes
- Seeking medical care for pelvic floor symptoms(from beginning of study to 12 months post-partum.)
- Adherence to pelvic floor exercises(From beginning of study to 12 months post-partum)
Investigators
Ola Malabarey
Gynecologist, Urogynecology speciality
Hamilton Health Sciences Corporation