Pregnancy ComplicationsNCT02682212
Obstetric Perineal Trauma and Physiotherapy
A study testing Physiotherapy intervention in people with Pregnancy Complications, run by Landspitali University Hospital at 1 site in Iceland.
Trial summary
The main objective is to investigate effects of perineal trauma at birth on women´s health and whether early physiotherapy improves pelvic floor strength. This will be achieved by an acknowledged/validated questionnaire sent electronically 6 weeks after first delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Complications
- What is being tested?
- Physiotherapy intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteIceland
- Study dates
- 16 Mar 2016to Jan 2018
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy primiparas after delivery at LSH
- ≥18 years
- Diagnosed with urinary incontinence according to the self administered Australian Pelvic floor Questionnaire (Icelandic version) 6 weeks post partum.
- Able to attend intervention in the capital area
- Answer the Australian Pelvic Floor Questionnaire
Who cannot join
- Diseases or conditions that can interfere with pelvic floor function (other than childbirth), such as prior pelvic floor surgery or ability to benefit from the intervention
- Women unable to understand Icelandic
- Woman with cognitive disabilities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Obstetric Perineal Trauma, Pelvic Floor Symptoms and Early Physiotherapy Intervention
The main objective is to investigate effects of perineal trauma at birth on women´s health and whether early physiotherapy improves pelvic floor strength. This will be achieved by an acknowledged/validated questionnaire sent electronically 6 weeks after first delivery. Women with symptomes of urinary incontinence according to the questionnaire will be offered participation in a single-blinded randomized intervention study to compare outcome after targeted physiotherapy with conventional advice and support. Intervention encompasses weekly pelvic floor training for 12 weeks. Pelvic strength will be measured and symptom information collected before and after intervention and 12 months postpartum in both groups.
Pelvic floor problems after delivery are common and often persistent, including urinary/fecal incontinence, pelvic organ prolapse and sexual problems. Such symptoms reduce QoL and handicap women in multiple ways, physically, psychologically and socially. More knowledge of whether interventions and guidelines in this field can improve health and QoL is required.
Read the detailed description
Single-blind randomized controlled trial (RCT) to assess and compare the effects of early pelvic floor muscle training and present standard care/advice on pelvic floor muscle (PFM) strength, symptoms from the pelvic floor and bothersome symptoms (QoL) after obstetric perineal repair.
Procedure/Study design: Single-blind randomized controlled trial.
Details of test administration and data collection methods:
PFM strength will be measured with Myomed 932® (Enraf-Nonius, Delft, Netherlands) for squeeze pressure, vaginally and rectally.
Pelvic floor symptoms, (bladder/bowel function, prolapse symptoms, sexual function) and bothersomeness will be measured with the validated Icelandic version of the Australian Female Pelvic Floor Questionnaire.
Assessment and treatment will begin from 6th week postpartum. After initial assessment, instruction on pelvic floor function the pelvic floor questionnaire administration, participants will be randomized to intervention and control groups by a person not involved in measurements or treatment. The intervention group will receive individual treatment by a physiotherapist not involved in the initial assesment. This will be in the form of intensive PFMT with vaginal/rectal pressure feedback once a week for 12 weeks and be encouraged to do daily exercises. Repeated assessment of pelvic floor function and questionnaire administration will be after 12 weeks for both groups and repeated 12 months after birth.
Assessment of pelvic floor function includes rectal/vaginal resting pressure, PFM strength (maximal voluntary contraction, strongest of three measured as a vaginal and anal squeeze pressure), and endurance for 10 sec (area under the curve both rectal and vaginal).
Preliminary assumption of power (beta) of 80% and a level of significance (alfa) of 5% and estimating 1 against 3 women with symptoms of urinary incontinence in treatment vs. control groups, respectively after intervention, ca. 40 women will be needed per group.
- Conditions
- Pregnancy Complications
- Being tested
- Physiotherapy intervention
- Keywords
- Pelvic floor, obstetrics, perineal tear, physiotherapy
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy interventionOther
Compare the effect of early physiotherapy intervention (pelvic floor muscle training, PFMT) with standard care on pelvic floor dysfunction symptoms, quality of life (QoL) and (pelvic floor muscle (PFM) strength, for women who answered the questionnaire positively for 1) urinary incontinence, 2) other dysfunction of the pelvic floor.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy intervention | Experimental | Intensive pelvic floor muscle training (PFMT) given by a physiotherapist with vaginal/rectal pressure feedback once a week for 12 weeks. Receives: Other: Physiotherapy intervention |
| No intervention | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary incontinence rates measured by scores on the Australian Female PelvicFloor questionnaire
Urinary incontinence rates measured by scores on the Australian Female PelvicFloor questionnaire
Measured: 16 weeks
Secondary outcomes (3)
Fecal/flatal incontinence measured by scores on the Australian Female PelvicFloor questionnaire
Fecal/flatal incontinence measured by scores on the Australian Female PelvicFloor questionnaire
Measured: 16 weeks
Sexual dysfunction measured by scores on the Australian Female PelvicFloor questionnaire
Sexual dysfunction measured by scores on the Australian Female PelvicFloor questionnaire
Measured: 16 weeks
Quality of life measured by scores on the Australian Female PelvicFloor questionnaire
Quality of life measured by scores on the Australian Female PelvicFloor questionnaire
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study start16 Mar 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy ComplicationsStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Landspitali University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iceland
- Responsible party
- Sponsor
- Investigators
- Thora Steingrimsdottir, MD, PhD, Principal investigator, Landspitali University Hospital/University of Iceland, Reykjavik, IcelandKari Bo, PhD, Study chair, Norwegian School of Sports Sciences, Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682212
- Sponsor's protocol ID
- LSH-15-001
- Status last verified
- Feb 2019
- First submitted
- 30 Mar 2015
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
PubMed 32378735Sigurdardottir T, Steingrimsdottir T, Geirsson RT, Halldorsson TI, Aspelund T, Bo K. Can postpartum pelvic floor muscle training reduce urinary and anal incontinence?: An assessor-blinded randomized controlled trial. Am J Obstet Gynecol. 2020 Mar;222(3):247.e1-247.e8. doi: 10.1016/j.ajog.2019.09.011. Epub 2019 Sep 14.
PubMed 31526791
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstetric Perineal Trauma, Pelvic Floor Symptoms and Early Physiotherapy Intervention
- ClinicalTrials.gov ID
- NCT02682212
- Acronym / sponsor ID
- LSH-15-001
- Conditions
- Pregnancy Complications
- Keywords
- Pelvic floor, obstetrics, perineal tear, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Landspitali University HospitalUniversity, hospital or other
- Collaborators
- University of Iceland
- Study start
- 16 Mar 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 15 Feb 2016 (estimated)
- 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.
The main objective is to investigate effects of perineal trauma at birth on women´s health and whether early physiotherapy improves pelvic floor strength. This will be achieved by an acknowledged/validated questionnaire sent electronically 6 weeks after first delivery. Women with symptomes of urinary incontinence according to the questionnaire will be offered participation in a single-blinded randomized intervention study to compare outcome after targeted physiotherapy with conventional advice and support. Intervention encompasses weekly pelvic floor training for 12 weeks. Pelvic strength will be measured and symptom information collected before and after intervention and 12 months postpartum in both groups.
Pelvic floor problems after delivery are common and often persistent, including urinary/fecal incontinence, pelvic organ prolapse and sexual problems. Such symptoms reduce QoL and handicap women in multiple ways, physically, psychologically and socially. More knowledge of whether interventions and guidelines in this field can improve health and QoL is required.
Detailed description
Single-blind randomized controlled trial (RCT) to assess and compare the effects of early pelvic floor muscle training and present standard care/advice on pelvic floor muscle (PFM) strength, symptoms from the pelvic floor and bothersome symptoms (QoL) after obstetric perineal repair.
Procedure/Study design: Single-blind randomized controlled trial.
Details of test administration and data collection methods:
PFM strength will be measured with Myomed 932® (Enraf-Nonius, Delft, Netherlands) for squeeze pressure, vaginally and rectally.
Pelvic floor symptoms, (bladder/bowel function, prolapse symptoms, sexual function) and bothersomeness will be measured with the validated Icelandic version of the Australian Female Pelvic Floor Questionnaire.
Assessment and treatment will begin from 6th week postpartum. After initial assessment, instruction on pelvic floor function the pelvic floor questionnaire administration, participants will be randomized to intervention and control groups by a person not involved in measurements or treatment. The intervention group will receive individual treatment by a physiotherapist not involved in the initial assesment. This will be in the form of intensive PFMT with vaginal/rectal pressure feedback once a week for 12 weeks and be encouraged to do daily exercises. Repeated assessment of pelvic floor function and questionnaire administration will be after 12 weeks for both groups and repeated 12 months after birth.
Assessment of pelvic floor function includes rectal/vaginal resting pressure, PFM strength (maximal voluntary contraction, strongest of three measured as a vaginal and anal squeeze pressure), and endurance for 10 sec (area under the curve both rectal and vaginal).
Preliminary assumption of power (beta) of 80% and a level of significance (alfa) of 5% and estimating 1 against 3 women with symptoms of urinary incontinence in treatment vs. control groups, respectively after intervention, ca. 40 women will be needed per group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy intervention | Experimental | Other: Physiotherapy interventionIntensive pelvic floor muscle training (PFMT) given by a physiotherapist with vaginal/rectal pressure feedback once a week for 12 weeks. |
| No intervention | No intervention | –Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy primiparas after delivery at LSH
- ≥18 years
- Diagnosed with urinary incontinence according to the self administered Australian Pelvic floor Questionnaire (Icelandic version) 6 weeks post partum.
- Able to attend intervention in the capital area
- Answer the Australian Pelvic Floor Questionnaire
Key exclusion criteria (3 listed)
- Diseases or conditions that can interfere with pelvic floor function (other than childbirth), such as prior pelvic floor surgery or ability to benefit from the intervention
- Women unable to understand Icelandic
- Woman with cognitive disabilities.
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 |
|---|---|---|
| Physiotherapy interventionCompare the effect of early physiotherapy intervention (pelvic floor muscle training, PFMT) with standard care on pelvic floor dysfunction symptoms, quality of life (QoL) and (pelvic floor muscle (PFM) strength, for women who answered the questionnaire positively for 1) urinary incontinence, 2) other dysfunction of the pelvic floor. | Other | Physiotherapy intervention |
Primary outcome
Urinary incontinence rates measured by scores on the Australian Female PelvicFloor questionnaire
Time frame: 16 weeks
Urinary incontinence rates measured by scores on the Australian Female PelvicFloor questionnaire
3 secondary outcomes
Fecal/flatal incontinence measured by scores on the Australian Female PelvicFloor questionnaire
Time frame: 16 weeks
Sexual dysfunction measured by scores on the Australian Female PelvicFloor questionnaire
Time frame: 16 weeks
Quality of life measured by scores on the Australian Female PelvicFloor questionnaire
Time frame: 16 weeks
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 16 Apr 2019.
- Derived from this study: PubMed 32378735Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
- Derived from this study: PubMed 31526791Sigurdardottir T, Steingrimsdottir T, Geirsson RT, Halldorsson TI, Aspelund T, Bo K. Can postpartum pelvic floor muscle training reduce urinary and anal incontinence?: An assessor-blinded randomized controlled trial. Am J Obstet Gynecol. 2020 Mar;222(3):247.e1-247.e8. doi: 10.1016/j.ajog.2019.09.011. Epub 2019 Sep 14.
- Individual participant dataSharing planned: No
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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.
Thora Steingrimsdottir, MD, PhD principal investigator
Landspitali University Hospital/University of Iceland, Reykjavik, Iceland
Kari Bo, PhD study chair
Norwegian School of Sports Sciences, Oslo, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy intervention in people with Pregnancy Complications, run by Landspitali University Hospital at 1 site in Iceland.
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 5 inclusion and 3 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 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iceland. 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?
Urinary incontinence rates measured by scores on the Australian Female PelvicFloor questionnaire (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02682212, which also lists 2 linked publications.
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 16 Apr 2019.