Ultrasound and Pelvic Floor Muscle Training

Ultrasound Clinical Trial

— ERP  

Official title:

Validity of Ultrasound in Women Having Pelvic Floor Muscle Training

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04361890
• Other study ID #: 2019-A01425-52
• Status: Recruiting
• Phase: N/A
• Start date: January 7, 2020
• Est. completion date: February 2022

Study information

• Verified date: August 2021
• Source: University Hospital, Caen
• Contact: Anne Cecile Pizzoferrato, MD
• Phone: +33682176675
• Email: acpizzofe[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective is to validate the use of ultrasound measurements (urethral mobility, movement of the ano-rectal angle, elastography measurements) in women with urinary incontiennce before and after pelvic floor muscle training (PFMT) : inter and intra-observer reproducibility; correlation with clinical examination (modified Oxford scale); sensitivity to change before/after pelvic floor muscle training

Description:

Introduction: Stress urinary incontinence (SUI) is defined by involuntary loss of urine. According to the literature, its prevalence ranges from 30 to 60%. The first-line treatment of SUI is pelvic floor muscle training (PFMT). The assessment of pelvic floor muscle (PFM) contraction is essentially clinical, based on the modified OXFORD system associated with symptom questionnaires. Ultrasound is more widely used in case of SUI but has never been evaluated before and after PFMT. Objective: The main objective of this study will be to carry out a validation study of ultrasound measurements in women with predominant SUI (urethral mobility, movement of the ano-rectal angle, elastography): Inter/intra-observer reproducibility; variability versus measurement by correlation with clinical examination (modified Oxford scale); sensitivity to change before/after PFMT Secondary objectives will be to show a correlation between the different ultrasound measurements and the clinical symptoms assessed by validated questionnaires : International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) and Contilife. A quantitative pulseal elastography analysis by Ultra-fast shear wave elastography (Supersonic Imagine) will also be performed before and after PFMT, looking for changes after PFMT. We Patient satisfaction after PFMT will also be assessed using the validated "Patient Global Impression of Improvement" questionnaire (PGI-I) Materials and Methods: This is a single-center prospective study involving patients in PFMT for predominant SUI. Patients will have a 10-week PFMT protocol. An evaluation will be conducted at the beginning and end of the program. This will include an assessment of symptoms using validated questionnaires (ICIQ-SF, CONTILIFE), a clinical examination (modified Oxford scale), as well as transperineal ultrasound measurements of urethral mobility (Bladder Neck Desent, BND measured in centimeters), movement of ano-rectal angle and quantitative elastography measurements (Ultra-fast shear wave, elasticity E expressed in kiloP).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• women over 18 years old
• referred for predominant SUI
• agreeing to participate in the study
• beneficiary of a social security scheme or entitled
• having been informed about the study (non-opposition)

Exclusion Criteria:

• Minor patients, under guardianship, under curator
• Patients who do not understand French
• Pregnant women
• Women with stage 2 or more prolapse according to the POP-Q classification
• Women with a history of:
• pelvis / spine trauma
• perineal pain
• urinary or vaginal infection
• perineal surgery for urinary incontinence and/or prolapse
• spinal surgery
• pacemaker
• respiratory pathology
• neurological disorders

Related Conditions & MeSH terms

• Contraction; Pelvic
• Elastography
• Ultrasound
• Urethral Hypermobility
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Incontinence,Stress

Intervention

Diagnostic Test:
• perineal ultrasound
all women will have ultrasound measurements of the bladder neck descent, of the movement of the ano-rectal angle during a Valsalva maneuver and elastographic measurement before and after PFMT. All measurement will be conducted by perineal route, with is a non invasive ultrasound route

Locations

Country	Name	City	State
France	Pizzoferato	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

References & Publications (34)

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Dietz HP, Clarke B. The influence of posture on perineal ultrasound imaging parameters. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(2):104-6. — View Citation

Dietz HP. Ultrasound imaging of the pelvic floor. Part I: two-dimensional aspects. Ultrasound Obstet Gynecol. 2004 Jan;23(1):80-92. Review. — View Citation

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Fritel X, Fauconnier A, Bader G, Cosson M, Debodinance P, Deffieux X, Denys P, Dompeyre P, Faltin D, Fatton B, Haab F, Hermieux JF, Kerdraon J, Mares P, Mellier G, Michel-Laaengh N, Nadeau C, Robain G, de Tayrac R, Jacquetin B; French College of Gynaecologists and Obstetricians. Diagnosis and management of adult female stress urinary incontinence: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians. Eur J Obstet Gynecol Reprod Biol. 2010 Jul;151(1):14-9. doi: 10.1016/j.ejogrb.2010.02.041. Epub 2010 Mar 16. Review. — View Citation

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Hung HC, Hsiao SM, Chih SY, Lin HH, Tsauo JY. Effect of pelvic-floor muscle strengthening on bladder neck mobility: a clinical trial. Phys Ther. 2011 Jul;91(7):1030-8. doi: 10.2522/ptj.20100186. Epub 2011 May 12. — View Citation

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Kreutzkamp JM, Schäfer SD, Amler S, Strube F, Kiesel L, Schmitz R. Strain Elastography as a New Method for Assessing Pelvic Floor Biomechanics. Ultrasound Med Biol. 2017 Apr;43(4):868-872. doi: 10.1016/j.ultrasmedbio.2016.12.004. Epub 2017 Jan 17. — View Citation

Messelink B, Benson T, Berghmans B, Bø K, Corcos J, Fowler C, Laycock J, Lim PH, van Lunsen R, á Nijeholt GL, Pemberton J, Wang A, Watier A, Van Kerrebroeck P. Standardization of terminology of pelvic floor muscle function and dysfunction: report from the pelvic floor clinical assessment group of the International Continence Society. Neurourol Urodyn. 2005;24(4):374-80. — View Citation

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Stafford RE, Aljuraifani R, Hug F, Hodges PW. Application of shear-wave elastography to estimate the stiffness of the male striated urethral sphincter during voluntary contractions. BJU Int. 2017 Apr;119(4):619-625. doi: 10.1111/bju.13688. Epub 2016 Nov 11. — 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

Tosun OC, Solmaz U, Ekin A, Tosun G, Gezer C, Ergenoglu AM, Yeniel AO, Mat E, Malkoc M, Askar N. Assessment of the effect of pelvic floor exercises on pelvic floor muscle strength using ultrasonography in patients with urinary incontinence: a prospective randomized controlled trial. J Phys Ther Sci. 2016 Jan;28(2):360-5. doi: 10.1589/jpts.28.360. Epub 2016 Feb 29. — View Citation

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bladder neck descent reliability before PFMT	2 measurements of the bladder neck descent during a Valsalva maneuver (as described by Dietz et al.) will be conducted by two operators using perineal ultrasound	2 years
Primary	ano-rectal angle mobility reliability before PFMT	2 measurements of the ano-rectal angle mobility during a Valsalva maneuver will be conducted by two operators using perineal ultrasound	2 years
Primary	perineal elastography reliability before PFMT	2 measurements of perineal elastography (periurethral measurements) will be conducted by two operators using perineal ultrasound	2 years
Primary	bladder neck descent change after PFMT	comparison of the bladder neck descent during a Valsalva maneuver (as described by Dietz et al.) will be conducted before and after PFMT using perineal ultrasound	2 years
Primary	ano-rectal angle mobility change after PFMT	comparison of the ano-rectal angle mobility during a Valsalva maneuver will be conducted before and after PFMT using perineal ultrasound	2 years
Primary	perineal elastogaphy change after PFMT	comparison of perineal elastography (periurethral measurements) will be conducted before and after PFMT using perineal ultrasound	2 years
Secondary	correlation analyses between bladder neck descent measurements and urinary symptoms	the bladder neck descent measurements will be compared before and after PFMT to the urinary symptoms using the validated questionnaire ICIQ-SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form)	2 years
Secondary	patients satisfaction after pelvic floor muscle training	the satisfaction will be assessed using the validated questionnaire "Patient Global Impression of Improvement" (PGI-I) after PFMT	2 years