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Ultrasound and Pelvic Floor Muscle Training (ERP)

Primary Purpose

Urinary Incontinence,Stress, Ultrasound, Elastography

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
perineal ultrasound
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urinary Incontinence,Stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • PizzoferatoRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Women with predominant SUI

Arm Description

All women with predominant SUI will be referred to a physiotherapist for PFMT as usually. They will have an ultrasound evaluation before and after the session

Outcomes

Primary Outcome Measures

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
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
perineal elastography reliability before PFMT
2 measurements of perineal elastography (periurethral measurements) will be conducted by two operators using perineal ultrasound
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
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
perineal elastogaphy change after PFMT
comparison of perineal elastography (periurethral measurements) will be conducted before and after PFMT using perineal ultrasound

Secondary Outcome Measures

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)
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

Full Information

First Posted
April 22, 2020
Last Updated
August 30, 2021
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT04361890
Brief Title
Ultrasound and Pelvic Floor Muscle Training
Acronym
ERP
Official Title
Validity of Ultrasound in Women Having Pelvic Floor Muscle Training
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 7, 2020 (Actual)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
February 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence,Stress, Ultrasound, Elastography, Contraction; Pelvic, Urethral Hypermobility

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
ultrasonographic measurements before and after pelvic floor muscle training
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Women with predominant SUI
Arm Type
Other
Arm Description
All women with predominant SUI will be referred to a physiotherapist for PFMT as usually. They will have an ultrasound evaluation before and after the session
Intervention Type
Diagnostic Test
Intervention Name(s)
perineal ultrasound
Intervention Description
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
Primary Outcome Measure Information:
Title
Bladder neck descent reliability before PFMT
Description
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
Time Frame
2 years
Title
ano-rectal angle mobility reliability before PFMT
Description
2 measurements of the ano-rectal angle mobility during a Valsalva maneuver will be conducted by two operators using perineal ultrasound
Time Frame
2 years
Title
perineal elastography reliability before PFMT
Description
2 measurements of perineal elastography (periurethral measurements) will be conducted by two operators using perineal ultrasound
Time Frame
2 years
Title
bladder neck descent change after PFMT
Description
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
Time Frame
2 years
Title
ano-rectal angle mobility change after PFMT
Description
comparison of the ano-rectal angle mobility during a Valsalva maneuver will be conducted before and after PFMT using perineal ultrasound
Time Frame
2 years
Title
perineal elastogaphy change after PFMT
Description
comparison of perineal elastography (periurethral measurements) will be conducted before and after PFMT using perineal ultrasound
Time Frame
2 years
Secondary Outcome Measure Information:
Title
correlation analyses between bladder neck descent measurements and urinary symptoms
Description
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)
Time Frame
2 years
Title
patients satisfaction after pelvic floor muscle training
Description
the satisfaction will be assessed using the validated questionnaire "Patient Global Impression of Improvement" (PGI-I) after PFMT
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Cecile Pizzoferrato, MD
Phone
+33682176675
Email
acpizzofe@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Estelle Jamard, MD
Phone
+33688323211
Email
jamard-e@chu-caen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clemence Tomadesso, PhD
Organizational Affiliation
University Hospital of Caen
Official's Role
Study Chair
Facility Information:
Facility Name
Pizzoferato
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Cecile Pizzoferrato, MD
Phone
+33231272336
Email
pizzoferrato-ac@chu-caen.fr
First Name & Middle Initial & Last Name & Degree
Estelle Jamard, MD
First Name & Middle Initial & Last Name & Degree
Helene Ricard

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11857671
Citation
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
Results Reference
background
PubMed Identifier
19941278
Citation
Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.
Results Reference
background
PubMed Identifier
8203431
Citation
DeLancey JO. Structural support of the urethra as it relates to stress urinary incontinence: the hammock hypothesis. Am J Obstet Gynecol. 1994 Jun;170(6):1713-20; discussion 1720-3. doi: 10.1016/s0002-9378(94)70346-9.
Results Reference
background
PubMed Identifier
8108659
Citation
Petros PE, Ulmsten UI. An integral theory and its method for the diagnosis and management of female urinary incontinence. Scand J Urol Nephrol Suppl. 1993;153:1-93. No abstract available.
Results Reference
background
PubMed Identifier
20236751
Citation
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.
Results Reference
background
PubMed Identifier
22999088
Citation
Hermieu JF, Denys P, Fritel X. [Critical review of guidelines for female urinary incontinence diagnosis and treatment]. Prog Urol. 2012 Oct;22(11):636-43. doi: 10.1016/j.purol.2012.08.004. Epub 2012 Sep 10. French.
Results Reference
background
PubMed Identifier
15977259
Citation
Messelink B, Benson T, Berghmans B, Bo K, Corcos J, Fowler C, Laycock J, Lim PH, van Lunsen R, a 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. doi: 10.1002/nau.20144. No abstract available.
Results Reference
background
PubMed Identifier
23725579
Citation
Deffieux X, Billecocq S, Demoulin G, Rivain AL, Trichot C, Thubert T. [Pelvic floor rehabilitation for female urinary incontinence: mechanisms of action]. Prog Urol. 2013 Jun;23(8):491-501. doi: 10.1016/j.purol.2013.04.002. Epub 2013 May 2. French.
Results Reference
background
PubMed Identifier
18204797
Citation
Miller JM, Sampselle C, Ashton-Miller J, Hong GR, DeLancey JO. Clarification and confirmation of the Knack maneuver: the effect of volitional pelvic floor muscle contraction to preempt expected stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Jun;19(6):773-82. doi: 10.1007/s00192-007-0525-3.
Results Reference
background
PubMed Identifier
21566065
Citation
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.
Results Reference
background
PubMed Identifier
10074990
Citation
Schaer GN, Perucchini D, Munz E, Peschers U, Koechli OR, Delancey JO. Sonographic evaluation of the bladder neck in continent and stress-incontinent women. Obstet Gynecol. 1999 Mar;93(3):412-6. doi: 10.1016/s0029-7844(98)00420-7.
Results Reference
background
PubMed Identifier
16978276
Citation
Balmforth JR, Mantle J, Bidmead J, Cardozo L. A prospective observational trial of pelvic floor muscle training for female stress urinary incontinence. BJU Int. 2006 Oct;98(4):811-7. doi: 10.1111/j.1464-410X.2006.06393.x.
Results Reference
background
PubMed Identifier
27065519
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.
Results Reference
background
PubMed Identifier
26300128
Citation
Volloyhaug I, Morkved S, Salvesen O, Salvesen KA. Assessment of pelvic floor muscle contraction with palpation, perineometry and transperineal ultrasound: a cross-sectional study. Ultrasound Obstet Gynecol. 2016 Jun;47(6):768-73. doi: 10.1002/uog.15731. Epub 2016 May 2.
Results Reference
background
PubMed Identifier
14971006
Citation
Dietz HP. Ultrasound imaging of the pelvic floor. Part I: two-dimensional aspects. Ultrasound Obstet Gynecol. 2004 Jan;23(1):80-92. doi: 10.1002/uog.939.
Results Reference
background
PubMed Identifier
3056562
Citation
Bergman A, McKenzie CJ, Richmond J, Ballard CA, Platt LD. Transrectal ultrasound versus cystography in the evaluation of anatomical stress urinary incontinence. Br J Urol. 1988 Sep;62(3):228-34. doi: 10.1111/j.1464-410x.1988.tb04324.x.
Results Reference
background
PubMed Identifier
1732608
Citation
Johnson JD, Lamensdorf H, Hollander IN, Thurman AE. Use of transvaginal endosonography in the evaluation of women with stress urinary incontinence. J Urol. 1992 Feb;147(2):421-5. doi: 10.1016/s0022-5347(17)37256-7.
Results Reference
background
PubMed Identifier
1638367
Citation
Wise BG, Burton G, Cutner A, Cardozo LD. Effect of vaginal ultrasound probe on lower urinary tract function. Br J Urol. 1992 Jul;70(1):12-6. doi: 10.1111/j.1464-410x.1992.tb15655.x.
Results Reference
background
PubMed Identifier
11715996
Citation
Alper T, Cetinkaya M, Okutgen S, Kokcu A, Malatyalioglu E. Evaluation of urethrovesical angle by ultrasound in women with and without urinary stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(5):308-11. doi: 10.1007/s001920170031.
Results Reference
background
PubMed Identifier
2668819
Citation
Koelbl H, Bernaschek G. A new method for sonographic urethrocystography and simultaneous pressure-flow measurements. Obstet Gynecol. 1989 Sep;74(3 Pt 1):417-22.
Results Reference
background
PubMed Identifier
15782286
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. doi: 10.1007/s00192-005-1308-3. Epub 2005 Mar 22.
Results Reference
background
PubMed Identifier
12355287
Citation
Dietz HP, Clarke B, Herbison P. Bladder neck mobility and urethral closure pressure as predictors of genuine stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2002;13(5):289-93. doi: 10.1007/s001920200063.
Results Reference
background
PubMed Identifier
11374506
Citation
Dietz HP, Clarke B. The influence of posture on perineal ultrasound imaging parameters. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(2):104-6. doi: 10.1007/pl00004030.
Results Reference
background
PubMed Identifier
19306473
Citation
Yang SH, Huang WC, Yang SY, Yang E, Yang JM. Validation of new ultrasound parameters for quantifying pelvic floor muscle contraction. Ultrasound Obstet Gynecol. 2009 Apr;33(4):465-71. doi: 10.1002/uog.6338.
Results Reference
background
PubMed Identifier
22749107
Citation
Ferraioli G, Tinelli C, Zicchetti M, Above E, Poma G, Di Gregorio M, Filice C. Reproducibility of real-time shear wave elastography in the evaluation of liver elasticity. Eur J Radiol. 2012 Nov;81(11):3102-6. doi: 10.1016/j.ejrad.2012.05.030. Epub 2012 Jun 27.
Results Reference
background
PubMed Identifier
22282182
Citation
Berg WA, Cosgrove DO, Dore CJ, Schafer FK, Svensson WE, Hooley RJ, Ohlinger R, Mendelson EB, Balu-Maestro C, Locatelli M, Tourasse C, Cavanaugh BC, Juhan V, Stavros AT, Tardivon A, Gay J, Henry JP, Cohen-Bacrie C; BE1 Investigators. Shear-wave elastography improves the specificity of breast US: the BE1 multinational study of 939 masses. Radiology. 2012 Feb;262(2):435-49. doi: 10.1148/radiol.11110640.
Results Reference
background
PubMed Identifier
22210408
Citation
Cosgrove DO, Berg WA, Dore CJ, Skyba DM, Henry JP, Gay J, Cohen-Bacrie C; BE1 Study Group. Shear wave elastography for breast masses is highly reproducible. Eur Radiol. 2012 May;22(5):1023-32. doi: 10.1007/s00330-011-2340-y. Epub 2011 Dec 31.
Results Reference
background
PubMed Identifier
28407305
Citation
Aljuraifani R, Stafford RE, Hug F, Hodges PW. Female striated urogenital sphincter contraction measured by shear wave elastography during pelvic floor muscle activation: Proof of concept and validation. Neurourol Urodyn. 2018 Jan;37(1):206-212. doi: 10.1002/nau.23275. Epub 2017 Apr 13.
Results Reference
background
PubMed Identifier
27753239
Citation
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.
Results Reference
background
PubMed Identifier
28108041
Citation
Kreutzkamp JM, Schafer 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.
Results Reference
background
PubMed Identifier
21185762
Citation
Pizzoferrato AC, Fauconnier A, Bader G. [Value of ultrasonographic measurement of bladder neck mobility in the management of female stress urinary incontinence]. Gynecol Obstet Fertil. 2011 Jan;39(1):42-8. doi: 10.1016/j.gyobfe.2010.09.019. Epub 2010 Dec 24. French.
Results Reference
background
PubMed Identifier
20013110
Citation
Srikrishna S, Robinson D, Cardozo L. Validation of the Patient Global Impression of Improvement (PGI-I) for urogenital prolapse. Int Urogynecol J. 2010 May;21(5):523-8. doi: 10.1007/s00192-009-1069-5. Epub 2009 Dec 15.
Results Reference
background
PubMed Identifier
15227649
Citation
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. doi: 10.1002/nau.20041.
Results Reference
background
PubMed Identifier
12667721
Citation
Amarenco G, Arnould B, Carita P, Haab F, Labat JJ, Richard F. European psychometric validation of the CONTILIFE: a Quality of Life questionnaire for urinary incontinence. Eur Urol. 2003 Apr;43(4):391-404. doi: 10.1016/s0302-2838(03)00054-x.
Results Reference
background

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Ultrasound and Pelvic Floor Muscle Training

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