Urinary IncontinencePhase 3PERLNCT00506116
Promoting Effective Recovery From Labor Urinary Incontinence (PERL)
A Phase 3 study testing Videotape, routine care, PME instruction, PME practice and record keeping (in diaries) and Non-directed or directed,spontaneous or sustained pushing in people with Urinary Incontinence and Pelvic Organ Prolapse, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to determine whether pushing during labor that is controlled by the woman results in less birth-related injury and less postpartum urinary incontinence (UI). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Pelvic Organ Prolapse, Perinatal Laceration
- What is being tested?
- Videotape, routine care, PME instruction, PME practice and record keeping (in diaries) and Non-directed or directed,spontaneous or sustained pushing
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1996to Dec 2006
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women giving birth for the first time who are:
- Age 18 years or older
- Less than 20 weeks gestation
- Expected vaginal birth without use of epidural analgesia
- Plan to reside in Southeast Michigan for one year following the birth of the infant.
Who cannot join
- History of genito-urinary or neuro-muscular pathology
- Previous pregnancy carried beyond 20 weeks gestation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
Official title: Promoting Effective Recovery From Labor Urinary Incontinence: Prevention Reducing Birthing Risk
The purpose of this study is to determine whether pushing during labor that is controlled by the woman results in less birth-related injury and less postpartum urinary incontinence (UI).
Read the detailed description
Birth related urinary incontinence (UI) is a predictor of UI in older women. Ways to protect the continence mechanism during delivery may diminish a woman's risk of UI later in life. We propose to study the functional anatomy of the pelvic floor as it relates to UI in women who are having their first baby. We hypothesize non-directed, spontaneous pushing is a protective strategy in decreasing the risk of immediate and long term UI. Longitudinal comparisons of pelvic floor characteristics will be taken at 35 week gestation and 6 weeks, 6 months, and 12 months postpartum. Study participants will be seen first at 20 weeks gestation for documentation of baseline levels of pelvic floor function, specifically voluntary and involuntary muscle strength, urinary continence status, and urethral support. They will be randomly assigned into non-directed, spontaneous (experimental) and directed, sustained pushing (control) groups. Alterations that may occur in urethral support before and after birth will be described through non-invasive urethral ultrasound.
- Being tested
- Videotape, routine care, PME instruction, PME practice and record keeping (in diaries), Non-directed or directed,spontaneous or sustained pushing, Data collection
- Keywords
- Pelvic floor muscle training, Self-directed pushing, Antenatal perineal massage
- Medical subject headings
- Urinary Incontinence, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videotape, routine care, PME instructionBehavioural
A 40 minute videotape about non-directed, spontaneous pushing and/or a videotape of antenatal perineal massage and pelvic muscle exerise (PME) at intake visit. The control women received routine care and PME instruction at intake visit.
PME practice and record keeping (in diaries)Behavioural
Non-directed or directed,spontaneous or sustained pushingBehavioural
Non-directed, spontaneous pushing (experimental group) with perineal massage vs. directed, sustained pushing during delivery.
Data collectionProcedure or surgery
Baseline at 20 weeks gestation; longitudinal at 35 weeks gestation, 6 weeks postpartum, 6 months postpartum, and 12 months postpartum
What is being measured
The primary outcome is the main question the study is designed to answer.
Leakage Index (
Measured: 20 and 35 weeks gestation, and 6 weeks, 6 months, and 12 months postpartum
Secondary outcomes (2)
Perineal status (Digital, speculum, chart review, ultrasound)
Measured: 35 week gestation and 6 weeks, 6 months, and 12 months postpartum
Pelvic Organ Prolapse Quantification System (POPQ)
Measured: 35 weeks gestation and 6 weeks, 6 months, and 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startJul 1996
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Investigators
- Carolyn M Sampselle, PhD,RNC,FAAN, Principal investigator, University of Michgan School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506116
- Sponsor's protocol ID
- R01NR4007-9
- Other IDs
- R01NR004007
- Acronym
- PERL
- Status last verified
- May 2007
- First submitted
- 23 Jul 2007
- Last updated
- 31 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
DeLancey JO, Sampselle CM, Punch MR. Kegel dyspareunia: levator ani myalgia caused by overexertion. Obstet Gynecol. 1993 Oct;82(4 Pt 2 Suppl):658-9.
PubMed 8378003Sampselle CM, Miller JM, Luecha Y, Fischer K, Rosten L. Provider support of spontaneous pushing during the second stage of labor. J Obstet Gynecol Neonatal Nurs. 2005 Nov-Dec;34(6):695-702. doi: 10.1177/0884217505281904.
PubMed 16282227Antonakos CL, Miller JM, Sampselle CM. Indices for studying urinary incontinence and levator ani function in primiparous women. J Clin Nurs. 2003 Jul;12(4):554-61. doi: 10.1046/j.1365-2702.2003.00747.x.
PubMed 12790869Armstrong SM, Miller JM, Benson K, Jain S, Panagopoulos K, DeLancey JO, Sampselle CM. Revisiting reliability of quantified perineal ultrasound: Bland and Altman analysis of a new protocol for the rectangular coordinate method. Neurourol Urodyn. 2006;25(7):731-8. doi: 10.1002/nau.20299.
PubMed 16897749Roberts JM, Gonzalez CBP, Sampselle C. Why do supportive birth attendants become directive of maternal bearing-down efforts in second-stage labor? J Midwifery Womens Health. 2007 Mar-Apr;52(2):134-141. doi: 10.1016/j.jmwh.2006.11.005.
PubMed 17336819
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Effective Recovery From Labor Urinary Incontinence: Prevention Reducing Birthing Risk
- ClinicalTrials.gov ID
- NCT00506116
- Acronym / sponsor ID
- PERL / R01NR4007-9
- Keywords
- Pelvic floor muscle training, Self-directed pushing, Antenatal perineal massage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jul 1996
- Study completion
- Dec 2006 (actual)
- First posted
- 25 Jul 2007 (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 purpose of this study is to determine whether pushing during labor that is controlled by the woman results in less birth-related injury and less postpartum urinary incontinence (UI).
Detailed description
Birth related urinary incontinence (UI) is a predictor of UI in older women. Ways to protect the continence mechanism during delivery may diminish a woman's risk of UI later in life. We propose to study the functional anatomy of the pelvic floor as it relates to UI in women who are having their first baby. We hypothesize non-directed, spontaneous pushing is a protective strategy in decreasing the risk of immediate and long term UI. Longitudinal comparisons of pelvic floor characteristics will be taken at 35 week gestation and 6 weeks, 6 months, and 12 months postpartum. Study participants will be seen first at 20 weeks gestation for documentation of baseline levels of pelvic floor function, specifically voluntary and involuntary muscle strength, urinary continence status, and urethral support. They will be randomly assigned into non-directed, spontaneous (experimental) and directed, sustained pushing (control) groups. Alterations that may occur in urethral support before and after birth will be described through non-invasive urethral ultrasound.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Less than 20 weeks gestation
- Expected vaginal birth without use of epidural analgesia
- Plan to reside in Southeast Michigan for one year following the birth of the infant.
Key exclusion criteria (2 listed)
- History of genito-urinary or neuro-muscular pathology
- Previous pregnancy carried beyond 20 weeks gestation.
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 |
|---|---|---|
| Videotape, routine care, PME instructionA 40 minute videotape about non-directed, spontaneous pushing and/or a videotape of antenatal perineal massage and pelvic muscle exerise (PME) at intake visit. The control women received routine care and PME instruction at intake visit. | Behavioural | – |
| PME practice and record keeping (in diaries) | Behavioural | – |
| Non-directed or directed,spontaneous or sustained pushingNon-directed, spontaneous pushing (experimental group) with perineal massage vs. directed, sustained pushing during delivery. | Behavioural | – |
| Data collectionBaseline at 20 weeks gestation; longitudinal at 35 weeks gestation, 6 weeks postpartum, 6 months postpartum, and 12 months postpartum | Procedure or surgery | – |
Primary outcome
Leakage Index (
Time frame: 20 and 35 weeks gestation, and 6 weeks, 6 months, and 12 months postpartum
2 secondary outcomes
Perineal status (Digital, speculum, chart review, ultrasound)
Time frame: 35 week gestation and 6 weeks, 6 months, and 12 months postpartum
Pelvic Organ Prolapse Quantification System (POPQ)
Time frame: 35 weeks gestation and 6 weeks, 6 months, and 12 months postpartum
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 31 Jul 2007.
- Background: PubMed 8378003DeLancey JO, Sampselle CM, Punch MR. Kegel dyspareunia: levator ani myalgia caused by overexertion. Obstet Gynecol. 1993 Oct;82(4 Pt 2 Suppl):658-9.
- Results publication: PubMed 16282227Sampselle CM, Miller JM, Luecha Y, Fischer K, Rosten L. Provider support of spontaneous pushing during the second stage of labor. J Obstet Gynecol Neonatal Nurs. 2005 Nov-Dec;34(6):695-702. doi: 10.1177/0884217505281904.
- Results publication: PubMed 12790869Antonakos CL, Miller JM, Sampselle CM. Indices for studying urinary incontinence and levator ani function in primiparous women. J Clin Nurs. 2003 Jul;12(4):554-61. doi: 10.1046/j.1365-2702.2003.00747.x.
- Results publication: PubMed 16897749Armstrong SM, Miller JM, Benson K, Jain S, Panagopoulos K, DeLancey JO, Sampselle CM. Revisiting reliability of quantified perineal ultrasound: Bland and Altman analysis of a new protocol for the rectangular coordinate method. Neurourol Urodyn. 2006;25(7):731-8. doi: 10.1002/nau.20299.
- Results publication: PubMed 17336819Roberts JM, Gonzalez CBP, Sampselle C. Why do supportive birth attendants become directive of maternal bearing-down efforts in second-stage labor? J Midwifery Womens Health. 2007 Mar-Apr;52(2):134-141. doi: 10.1016/j.jmwh.2006.11.005.
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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.
Carolyn M Sampselle, PhD,RNC,FAAN principal investigator
University of Michgan School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Videotape, routine care, PME instruction, PME practice and record keeping (in diaries) and Non-directed or directed,spontaneous or sustained pushing in people with Urinary Incontinence and Pelvic Organ Prolapse, run by University of Michigan at 1 site in United States.
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 2 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 31 Jul 2007. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Leakage Index ( (time frame: 20 and 35 weeks gestation, and 6 weeks, 6 months, and 12 months postpartum). 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 NCT00506116, which also lists 5 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 31 Jul 2007.