Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01694979
Other study ID # L12-020
Secondary ID
Status Completed
Phase N/A
First received September 24, 2012
Last updated September 26, 2012
Start date February 2012
Est. completion date February 2012

Study information

Verified date September 2012
Source Kitani, Lenore, PT
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- women

- young (age 18-35)

- nulliparous

- pre-menopausal

Exclusion Criteria:

- pregnancy

- history of lower back or pelvic pain

- history of lower back or pelvic surgeries

- incontinence

- history of pelvic floor dysfunction

- diabetes

- endometriosis

- neuromuscular disease

- connective tissue disease

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Other:
Minimum expiration effort
Subjects perform a forced expiration at minimum effort
Moderate expiration effort
Subjects perform a forced expiration at moderate effort
Maximum expiration effort
Subjects perform a forced expiration at maximum effort

Locations

Country Name City State
United States Texas Tech University Health Sciences Center, Clinical Musculoskeletal Research Laboratory Lubbock Texas

Sponsors (1)

Lead Sponsor Collaborator
Kitani, Lenore, PT

Country where clinical trial is conducted

United States, 

References & Publications (28)

Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. — View Citation

Barbic M, Kralj B, Cör A. Compliance of the bladder neck supporting structures: importance of activity pattern of levator ani muscle and content of elastic fibers of endopelvic fascia. Neurourol Urodyn. 2003;22(4):269-76. — View Citation

Bo K, Berghmans B, Mørkved Siv, Van Kampen Marijke. Evidence-based physical therapy for the pelvic floor. 1st ed. Philedelphia, PA: Elsevier; 2007.

Bø K, Constantinou C. Reflex contraction of pelvic floor muscles during cough cannot be measured with vaginal pressure devices. Neurourol Urodyn. 2011 Sep;30(7):1404. doi: 10.1002/nau.20993. Epub 2011 Mar 14. — View Citation

Bø 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. — View Citation

Bo K, Kvarstein B, Hagen RR, Larsen S. Pelvic floor muscle exercise for the treatment of female stress urinary incontinence: II. Validity of vaginal pressure measurements of pelvic floor muscle strength and the necessity of supplementary methods for control of correct contraction. Neurourol Urodyn 1990;9(5):479-487.

Constantinou CE, Hvistendahl G, Ryhammer A, Nagel LL, Djurhuus JC. Determining the displacement of the pelvic floor and pelvic organs during voluntary contractions using magnetic resonance imaging in younger and older women. BJU Int. 2002 Sep;90(4):408-14. — View Citation

Dietz HP. Pelvic floor ultrasound: a review. Am J Obstet Gynecol. 2010 Apr;202(4):321-34. doi: 10.1016/j.ajog.2009.08.018. Review. — View Citation

Dinc A, Kizilkaya Beji N, Yalcin O. Effect of pelvic floor muscle exercises in the treatment of urinary incontinence during pregnancy and the postpartum period. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Oct;20(10):1223-31. doi: 10.1007/s00192-009-0929-3. Epub 2009 Aug 1. — View Citation

Ferreira CH, Barbosa PB, de Oliveira Souza F, Antônio FI, Franco MM, Bø 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. — View Citation

Frawley HC, Galea MP, Phillips BA, Sherburn M, Bø K. Reliability of pelvic floor muscle strength assessment using different test positions and tools. Neurourol Urodyn. 2006;25(3):236-42. — View Citation

Hodges PW, Sapsford R, Pengel LH. Postural and respiratory functions of the pelvic floor muscles. Neurourol Urodyn. 2007;26(3):362-71. — View Citation

Hung HC, Hsiao SM, Chih SY, Lin HH, Tsauo JY. An alternative intervention for urinary incontinence: retraining diaphragmatic, deep abdominal and pelvic floor muscle coordinated function. Man Ther. 2010 Jun;15(3):273-9. doi: 10.1016/j.math.2010.01.008. Epub 2010 Feb 24. — View Citation

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. — View Citation

Miller JM, Perucchini D, Carchidi LT, DeLancey JO, Ashton-Miller J. Pelvic floor muscle contraction during a cough and decreased vesical neck mobility. Obstet Gynecol. 2001 Feb;97(2):255-60. — View Citation

Morin M, Bourbonnais D, Gravel D, Dumoulin C, Lemieux MC. Pelvic floor muscle function in continent and stress urinary incontinent women using dynamometric measurements. Neurourol Urodyn. 2004;23(7):668-74. — View Citation

Neumann 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. — View Citation

Peschers 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. — View Citation

Pregazzi 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. — View Citation

Sapsford R. Rehabilitation of pelvic floor muscles utilizing trunk stabilization. Man Ther. 2004 Feb;9(1):3-12. Review. — View Citation

Schaer GN, Koechli OR, Schuessler B, Haller U. Perineal ultrasound for evaluating the bladder neck in urinary stress incontinence. Obstet Gynecol. 1995 Feb;85(2):220-4. — View Citation

Sherburn M, Bird M, Carey M, Bø K, Galea MP. Incontinence improves in older women after intensive pelvic floor muscle training: an assessor-blinded randomized controlled trial. Neurourol Urodyn. 2011 Mar;30(3):317-24. doi: 10.1002/nau.20968. Epub 2011 Jan 31. — View Citation

Shishido 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. — View Citation

Smith 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. Epub 2006 Dec 1. — View Citation

Talasz 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. — View Citation

Teleman PM, Gunnarsson M, Lidfeldt J, Nerbrand C, Samsioe G, Mattiasson A. Urethral pressure changes in response to squeeze: a population-based study in healthy and incontinent 53- to 63-year-old women. Am J Obstet Gynecol. 2003 Oct;189(4):1100-5. — View Citation

Thompson 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. Epub 2005 Mar 22. — View Citation

Thompson 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. Epub 2003 Apr 24. — View Citation

* Note: There are 28 references in allClick here to view all references

See also
  Status Clinical Trial Phase
Withdrawn NCT00730119 - Evaluation Of The GE Monitor Product Line N/A
Not yet recruiting NCT05621642 - Telerehabilitation Based Exercise Training in Parkinson's Patients N/A
Completed NCT06354400 - Core Stabilization Training on Chest Expansion, Functional Capacity, Trunk Muscle Endurance in Hearing-Impaired Children N/A
Completed NCT01176539 - Substantial Equivalence Study for Kai Medical Non-Contact Respiratory Rate Monitor N/A
Recruiting NCT05302219 - Plethysmography Curve Variability Depending on the Breath Cycle N/A
Completed NCT03153345 - The Efficacy of Bedside Respiratory Muscle Training in Stroke Patients N/A
Recruiting NCT01324817 - Substantial Equivalence Study for Kai Medical Non-Contact Respiratory Rate Monitors for Use With Neonates N/A
Completed NCT00827905 - Substantial Equivalence Study for Kai Sensors RSpot Non-Contact Respiratory Rate Spot Check N/A
Completed NCT02946502 - Handgrip Strength Value in Predicting Mechanical Ventilation Weaning N/A
Completed NCT06247943 - Lung Protective Ventilation Strategies N/A
Withdrawn NCT01062789 - Optical Breath-hold Control System for Image-guided Procedures Phase 0
Completed NCT00893087 - Comparison of Pressure-, Flow- and Neurally Adjusted Ventilatory Assistance (NAVA)-Triggering in Pediatric and Neonatal Ventilatory Care N/A
Completed NCT00730054 - Clonidine-Remifentanil. Effect of the Combination on Acute Pain and Respiration in Healthy Volunteers Phase 1/Phase 2
Completed NCT03119103 - Functional Bed Sheet Capturing Pressure Variation and Respiratory Effort Over Time N/A
Completed NCT05886153 - Verification Protocol for the Cloud DX Vitaliti Continuous Vital Signs Monitor (VERDICT-2) N/A
Recruiting NCT03206528 - Clinical Evaluation of the Vital Signs Monitoring System (VSMS) N/A