Pelvic FloorNCT01694979
Pelvic Floor Activity and Breathing in Women
An observational study of Pelvic Floor and Respiration, run by Kitani, Lenore, PT at 1 site in United States.
Trial summary
The pelvic floor and diaphragm work together in many different functions. Two important functions are breathing and continence. The pelvic floor muscles have to lift and squeeze to maintain continence. Breathing, specifically breathing out, makes the pelvic floor lift. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor, Respiration
- What is being tested?
- Minimum expiration effort, Moderate expiration effort and Maximum expiration effort
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Feb 2012
- Phase
- Observational
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Convenience sample from a University student, faculty and staff population.
Who may be able to join
- women
- young (age 18-35)
- nulliparous
- pre-menopausal
Who cannot join
- pregnancy
- history of lower back or pelvic pain
- history of lower back or pelvic surgeries
- incontinence
- history of pelvic floor dysfunction
- diabetes
Show all 9Show fewer
- endometriosis
- neuromuscular disease
- connective tissue disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center, Clinical Musculoskeletal Research Laboratory
Lubbock, Texas, 79430
About this study
Official title: Effect Of Variations In Forced Expiration Effort On Pelvic Floor Activation In Asymptomatic Women
The pelvic floor and diaphragm work together in many different functions. Two important functions are breathing and continence. The pelvic floor muscles have to lift and squeeze to maintain continence. Breathing, specifically breathing out, makes the pelvic floor lift. The investigators don't know how much the pelvic floor lifts and squeezes during different types of breathing out. The purpose of this study is to measure pelvic floor lift and squeeze during different types of breathing out.
Read the detailed description
The pelvic floor (PF) activates automatically, both squeezing and lifting, during times of increased intra-abdominal pressure for postural stability and continence. Expiration additionally produces automatic activation of the PF. No study to date has investigated the effects of forced expiration on PF displacement and squeeze pressure. The purpose of this study was to investigate the effects of variations in forced expiration effort on PF muscles' automatic activation.
- Conditions
- Pelvic Floor, Respiration
- Being tested
- Minimum expiration effort, Moderate expiration effort, Maximum expiration effort
- Keywords
- Pelvic floor, Rehabilitation, Respiration, Urinary incontinence
- Medical subject headings
- Respiratory Aspiration, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimum expiration effortOther
Subjects perform a forced expiration at minimum effort
Moderate expiration effortOther
Subjects perform a forced expiration at moderate effort
Maximum expiration effortOther
Subjects perform a forced expiration at maximum effort
| Study group | Role | What they receive |
|---|---|---|
| Single group: pelvic floor and breathing | This is a single group with repeated measures during variable breathing effort Receives: Other: Minimum expiration effort; Other: Moderate expiration effort; Other: Maximum expiration effort |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Pelvic FloorStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kitani, Lenore, PT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lenore J Kitani, B.S. PT, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694979
- Sponsor's protocol ID
- L12-020
- Status last verified
- Sep 2012
- First submitted
- 24 Sep 2012
- Last updated
- 27 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Hodges PW, Sapsford R, Pengel LH. Postural and respiratory functions of the pelvic floor muscles. Neurourol Urodyn. 2007;26(3):362-71. doi: 10.1002/nau.20232.
PubMed 17304528Bo K, Berghmans B, Mørkved Siv, Van Kampen Marijke. Evidence-based physical therapy for the pelvic floor. 1st ed. Philedelphia, PA: Elsevier; 2007.
Junginger B, Baessler K, Sapsford R, Hodges PW. Effect of abdominal and pelvic floor tasks on muscle activity, abdominal pressure and bladder neck. Int Urogynecol J. 2010 Jan;21(1):69-77. doi: 10.1007/s00192-009-0981-z.
PubMed 19730763Thompson JA, O'Sullivan PB. Levator plate movement during voluntary pelvic floor muscle contraction in subjects with incontinence and prolapse: a cross-sectional study and review. Int Urogynecol J Pelvic Floor Dysfunct. 2003 Jun;14(2):84-8. doi: 10.1007/s00192-003-1036-5. Epub 2003 Apr 24.
PubMed 12851748Talasz H, Kremser C, Kofler M, Kalchschmid E, Lechleitner M, Rudisch A. Phase-locked parallel movement of diaphragm and pelvic floor during breathing and coughing-a dynamic MRI investigation in healthy females. Int Urogynecol J. 2011 Jan;22(1):61-8. doi: 10.1007/s00192-010-1240-z. Epub 2010 Aug 31.
PubMed 20809211Neumann P, Gill V. Pelvic floor and abdominal muscle interaction: EMG activity and intra-abdominal pressure. Int Urogynecol J Pelvic Floor Dysfunct. 2002;13(2):125-32. doi: 10.1007/s001920200027.
PubMed 12054180Smith MD, Coppieters MW, Hodges PW. Postural activity of the pelvic floor muscles is delayed during rapid arm movements in women with stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Aug;18(8):901-11. doi: 10.1007/s00192-006-0259-7. Epub 2006 Dec 1.
PubMed 17139463Ferreira CH, Barbosa PB, de Oliveira Souza F, Antonio FI, Franco MM, Bo K. Inter-rater reliability study of the modified Oxford Grading Scale and the Peritron manometer. Physiotherapy. 2011 Jun;97(2):132-8. doi: 10.1016/j.physio.2010.06.007. Epub 2010 Oct 22.
PubMed 21497247Frawley HC, Galea MP, Phillips BA, Sherburn M, Bo K. Reliability of pelvic floor muscle strength assessment using different test positions and tools. Neurourol Urodyn. 2006;25(3):236-242. doi: 10.1002/nau.20201.
PubMed 16299815Dietz HP. Pelvic floor ultrasound: a review. Am J Obstet Gynecol. 2010 Apr;202(4):321-34. doi: 10.1016/j.ajog.2009.08.018.
PubMed 20350640Pregazzi R, Sartore A, Bortoli P, Grimaldi E, Troiano L, Guaschino S. Perineal ultrasound evaluation of urethral angle and bladder neck mobility in women with stress urinary incontinence. BJOG. 2002 Jul;109(7):821-7. doi: 10.1111/j.1471-0528.2002.01163.x.
PubMed 12135220Peschers UM, Gingelmaier A, Jundt K, Leib B, Dimpfl T. Evaluation of pelvic floor muscle strength using four different techniques. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(1):27-30. doi: 10.1007/s001920170090.
PubMed 11294527Thompson JA, O'Sullivan PB, Briffa K, Neumann P, Court S. Assessment of pelvic floor movement using transabdominal and transperineal ultrasound. Int Urogynecol J Pelvic Floor Dysfunct. 2005 Jul-Aug;16(4):285-92. doi: 10.1007/s00192-005-1308-3. Epub 2005 Mar 22.
PubMed 15782286Shishido K, Peng Q, Jones R, Omata S, Constantinou CE. Influence of pelvic floor muscle contraction on the profile of vaginal closure pressure in continent and stress urinary incontinent women. J Urol. 2008 May;179(5):1917-22. doi: 10.1016/j.juro.2008.01.020. Epub 2008 Mar 18.
PubMed 18353401Bo K, Finckenhagen HB. Is there any difference in measurement of pelvic floor muscle strength in supine and standing position? Acta Obstet Gynecol Scand. 2003 Dec;82(12):1120-4. doi: 10.1046/j.1600-0412.2003.00240.x.
PubMed 14616257
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Variations In Forced Expiration Effort On Pelvic Floor Activation In Asymptomatic Women
- ClinicalTrials.gov ID
- NCT01694979
- Acronym / sponsor ID
- L12-020
- Conditions
- Pelvic Floor, Respiration
- Keywords
- Pelvic floor, Rehabilitation, Respiration, Urinary incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Kitani, Lenore, PTUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 27 Sep 2012 (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 pelvic floor and diaphragm work together in many different functions. Two important functions are breathing and continence. The pelvic floor muscles have to lift and squeeze to maintain continence. Breathing, specifically breathing out, makes the pelvic floor lift. The investigators don't know how much the pelvic floor lifts and squeezes during different types of breathing out. The purpose of this study is to measure pelvic floor lift and squeeze during different types of breathing out.
Detailed description
The pelvic floor (PF) activates automatically, both squeezing and lifting, during times of increased intra-abdominal pressure for postural stability and continence. Expiration additionally produces automatic activation of the PF. No study to date has investigated the effects of forced expiration on PF displacement and squeeze pressure. The purpose of this study was to investigate the effects of variations in forced expiration effort on PF muscles' automatic activation.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group: pelvic floor and breathing | – | Other: Minimum expiration effort, Other: Moderate expiration effort, Other: Maximum expiration effortThis is a single group with repeated measures during variable breathing effort |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Convenience sample from a University student, faculty and staff population.
Key inclusion criteria (4 listed)
- women
- young (age 18-35)
- nulliparous
- pre-menopausal
Key exclusion criteria (9 listed)
- pregnancy
- history of lower back or pelvic pain
- history of lower back or pelvic surgeries
- incontinence
- history of pelvic floor dysfunction
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 |
|---|---|---|
| Minimum expiration effortSubjects perform a forced expiration at minimum effort | Other | Single group: pelvic floor and breathing |
| Moderate expiration effortSubjects perform a forced expiration at moderate effort | Other | Single group: pelvic floor and breathing |
| Maximum expiration effortSubjects perform a forced expiration at maximum effort | Other | Single group: pelvic floor and breathing |
Primary outcome
Not reported in the source record.
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 27 Sep 2012.
- Background: PubMed 17304528Hodges PW, Sapsford R, Pengel LH. Postural and respiratory functions of the pelvic floor muscles. Neurourol Urodyn. 2007;26(3):362-71. doi: 10.1002/nau.20232.
- BackgroundBo K, Berghmans B, Mørkved Siv, Van Kampen Marijke. Evidence-based physical therapy for the pelvic floor. 1st ed. Philedelphia, PA: Elsevier; 2007.
- Background: PubMed 19730763Junginger B, Baessler K, Sapsford R, Hodges PW. Effect of abdominal and pelvic floor tasks on muscle activity, abdominal pressure and bladder neck. Int Urogynecol J. 2010 Jan;21(1):69-77. doi: 10.1007/s00192-009-0981-z.
- Background: PubMed 12851748Thompson JA, O'Sullivan PB. Levator plate movement during voluntary pelvic floor muscle contraction in subjects with incontinence and prolapse: a cross-sectional study and review. Int Urogynecol J Pelvic Floor Dysfunct. 2003 Jun;14(2):84-8. doi: 10.1007/s00192-003-1036-5. Epub 2003 Apr 24.
- Background: PubMed 20809211Talasz H, Kremser C, Kofler M, Kalchschmid E, Lechleitner M, Rudisch A. Phase-locked parallel movement of diaphragm and pelvic floor during breathing and coughing-a dynamic MRI investigation in healthy females. Int Urogynecol J. 2011 Jan;22(1):61-8. doi: 10.1007/s00192-010-1240-z. Epub 2010 Aug 31.
- Background: PubMed 12054180Neumann P, Gill V. Pelvic floor and abdominal muscle interaction: EMG activity and intra-abdominal pressure. Int Urogynecol J Pelvic Floor Dysfunct. 2002;13(2):125-32. doi: 10.1007/s001920200027.
- Background: PubMed 17139463Smith MD, Coppieters MW, Hodges PW. Postural activity of the pelvic floor muscles is delayed during rapid arm movements in women with stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Aug;18(8):901-11. doi: 10.1007/s00192-006-0259-7. Epub 2006 Dec 1.
- Background: PubMed 21497247Ferreira CH, Barbosa PB, de Oliveira Souza F, Antonio FI, Franco MM, Bo K. Inter-rater reliability study of the modified Oxford Grading Scale and the Peritron manometer. Physiotherapy. 2011 Jun;97(2):132-8. doi: 10.1016/j.physio.2010.06.007. Epub 2010 Oct 22.
- Background: PubMed 16299815Frawley HC, Galea MP, Phillips BA, Sherburn M, Bo K. Reliability of pelvic floor muscle strength assessment using different test positions and tools. Neurourol Urodyn. 2006;25(3):236-242. doi: 10.1002/nau.20201.
- Background: PubMed 20350640Dietz HP. Pelvic floor ultrasound: a review. Am J Obstet Gynecol. 2010 Apr;202(4):321-34. doi: 10.1016/j.ajog.2009.08.018.
- Background: PubMed 12135220Pregazzi R, Sartore A, Bortoli P, Grimaldi E, Troiano L, Guaschino S. Perineal ultrasound evaluation of urethral angle and bladder neck mobility in women with stress urinary incontinence. BJOG. 2002 Jul;109(7):821-7. doi: 10.1111/j.1471-0528.2002.01163.x.
- Background: PubMed 11294527Peschers UM, Gingelmaier A, Jundt K, Leib B, Dimpfl T. Evaluation of pelvic floor muscle strength using four different techniques. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(1):27-30. doi: 10.1007/s001920170090.
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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.
Lenore J Kitani, B.S. PT principal investigator
Texas Tech University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor and Respiration, run by Kitani, Lenore, PT 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 4 inclusion and 9 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 27 Sep 2012. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01694979, which also lists 28 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 27 Sep 2012.