Pelvic Floor DisordersPPFWNCT04754984
Postpartum Pelvic Floor Workshop
A study testing Pelvic floor workshop in people with Pelvic Floor Disorders and Pelvic Floor; Incompetency, run by Hamilton Health Sciences Corporation at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pelvic Floor Disorders, Pelvic Floor; Incompetency, Pelvic Floor Muscle Weakness
- What is being tested?
- Pelvic floor workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Feb 2021to 20 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
About this study
Official title: A Randomized Trial: Can a Postpartum Pelvic Floor Education Workshop in a High-Risk Population Improve Pelvic Floor Symptoms?
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.
Read the 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.
- Conditions
- Pelvic Floor Disorders, Pelvic Floor; Incompetency, Pelvic Floor Muscle Weakness, Perineum; Injury
- Being tested
- Pelvic floor workshop
- Keywords
- postpartum perineal education
- Medical subject headings
- Pelvic Floor Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor workshopBehavioural
Physiotherapist-led workshop on managing pelvic floor symptoms
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | One-time in-person workshop with pelvic floor physiotherapist Receives: Behavioral: Pelvic floor workshop |
| Control | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic floor distress inventory
Survey on symptoms of pelvic floor distress
Measured: Differences between groups in the change in score from beginning of study to 3 months post-partum
Pelvic floor distress inventory
Survey on symptoms of pelvic floor distress
Measured: Differences between groups in the change in score from beginning of study to 6 months post-partum
Pelvic floor distress inventory
Validated survey on symptoms of pelvic floor distress
Measured: Differences between groups in the change in score from beginning of study to 12 months post-partum
Secondary outcomes (2)
Adherence to pelvic floor exercises
Investigator generated questions; Difference between groups in proportion who reported adherence to pelvic floor exercises
Measured: From beginning of study to 12 months post-partum
Seeking medical care for pelvic floor symptoms
Investigator generated questions: Difference between groups in proportion who reported seeking medical care for their symptoms
Measured: from beginning of study to 12 months post-partum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start1 Feb 2021
- Primary completion20 Mar 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to the intervention or control group. The intervention group will receive the perineal education workshop. The control group will receive standard care. Both groups will receive surveys at baseline, 3, 6 and 12 months postpartum to assess pelvic floor distress.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Malabarey, Hamilton Health Sciences Corporation
- Investigators
- Ola Malabarey, Principal investigator, Hamilton Health Sciences, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754984
- Sponsor's protocol ID
- 2020-10672
- Acronym
- PPFW
- Status last verified
- Jan 2024
- First submitted
- 9 Feb 2021
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no place to share IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial: Can a Postpartum Pelvic Floor Education Workshop in a High-Risk Population Improve Pelvic Floor Symptoms?
- ClinicalTrials.gov ID
- NCT04754984
- Acronym / sponsor ID
- PPFW / 2020-10672
- Conditions
- Pelvic Floor Disorders, Pelvic Floor; Incompetency, Pelvic Floor Muscle Weakness, Perineum; Injury
- Keywords
- postpartum perineal education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to the intervention or control group. The intervention group will receive the perineal education workshop. The control group will receive standard care. Both groups will receive surveys at baseline, 3, 6 and 12 months postpartum to assess pelvic floor distress.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Pelvic floor workshopOne-time in-person workshop with pelvic floor physiotherapist |
| Control | No intervention | –Standard care |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor workshopPhysiotherapist-led workshop on managing pelvic floor symptoms | Behavioural | Intervention |
Primary outcome
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
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
2 secondary outcomes
Adherence to pelvic floor exercises
Time frame: From beginning of study to 12 months post-partum
Seeking medical care for pelvic floor symptoms
Time frame: from beginning of study to 12 months post-partum.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: No. There is no place to share IPD with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ola Malabarey principal investigator
Hamilton Health Sciences, McMaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor workshop in people with Pelvic Floor Disorders and Pelvic Floor; Incompetency, run by Hamilton Health Sciences Corporation at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic floor distress inventory (time frame: Differences between groups in the change in score from beginning of study to 3 months post-partum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.