Urinary Incontinence,StressERPNCT04361890
Ultrasound and Pelvic Floor Muscle Training
A study testing perineal ultrasound in people with Urinary Incontinence,Stress and Ultrasound, run by University Hospital, Caen at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence,Stress, Ultrasound, Elastography
- What is being tested?
- perineal ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2020to Feb 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- perineal pain
- urinary or vaginal infection
- perineal surgery for urinary incontinence and/or prolapse
- spinal surgery
- pacemaker
- respiratory pathology
- neurological disorders
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Pizzoferato
Caen, 14000
Anne Cecile Pizzoferrato, MD, +33231272336, pizzoferrato-ac@chu-caen.fr
Estelle Jamard, MD
About this study
Official title: Validity of Ultrasound in Women Having Pelvic Floor Muscle Training
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
Read the 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).
- Conditions
- Urinary Incontinence,Stress, Ultrasound, Elastography, Contraction; Pelvic, Urethral Hypermobility
- Being tested
- perineal ultrasound
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perineal ultrasoundDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Women with predominant SUI | Other | 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 Receives: Diagnostic Test: perineal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
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
Measured: 2 years
perineal elastography reliability before PFMT
2 measurements of perineal elastography (periurethral measurements) will be conducted by two operators using perineal ultrasound
Measured: 2 years
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
Measured: 2 years
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
Measured: 2 years
perineal elastogaphy change after PFMT
comparison of perineal elastography (periurethral measurements) will be conducted before and after PFMT using perineal ultrasound
Measured: 2 years
Secondary outcomes (2)
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)
Measured: 2 years
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start7 Jan 2020
- Primary completionFeb 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence,StressStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- ultrasonographic measurements before and after pelvic floor muscle training
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clemence Tomadesso, PhD, Study chair, University Hospital of Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361890
- Sponsor's protocol ID
- 2019-A01425-52
- Acronym
- ERP
- Status last verified
- Aug 2021
- First submitted
- 22 Apr 2020
- Last updated
- 5 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11857671Haylen 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.
PubMed 19941278DeLancey 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.
PubMed 8203431Petros 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.
PubMed 8108659Fritel 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.
PubMed 20236751Hermieu 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.
PubMed 22999088Messelink 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.
PubMed 15977259Deffieux 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.
PubMed 23725579Miller 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.
PubMed 18204797Hung 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.
PubMed 21566065Schaer 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.
PubMed 10074990Balmforth 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.
PubMed 16978276Tosun 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.
PubMed 27065519Volloyhaug 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.
PubMed 26300128Dietz 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.
PubMed 14971006
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Ultrasound in Women Having Pelvic Floor Muscle Training
- ClinicalTrials.gov ID
- NCT04361890
- Acronym / sponsor ID
- ERP / 2019-A01425-52
- Conditions
- Urinary Incontinence,Stress, Ultrasound, Elastography, Contraction; Pelvic, Urethral Hypermobility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 24 Apr 2020 (actual)
- 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 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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- ultrasonographic measurements before and after pelvic floor muscle training
| Arm | Type | Receives |
|---|---|---|
| Women with predominant SUI | Other | Diagnostic Test: perineal ultrasoundAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (13 listed)
- 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:
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 |
|---|---|---|
| perineal ultrasoundall 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 | Diagnostic test | Women with predominant SUI |
Primary outcome
Bladder neck descent reliability before PFMT
Time frame: 2 years
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
Time frame: 2 years
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
Time frame: 2 years
2 measurements of perineal elastography (periurethral measurements) will be conducted by two operators using perineal ultrasound
bladder neck descent change after PFMT
Time frame: 2 years
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
Time frame: 2 years
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
Time frame: 2 years
comparison of perineal elastography (periurethral measurements) will be conducted before and after PFMT using perineal ultrasound
2 secondary outcomes
correlation analyses between bladder neck descent measurements and urinary symptoms
Time frame: 2 years
patients satisfaction after pelvic floor muscle training
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Background: PubMed 11857671Abrams 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.
- Background: PubMed 19941278Haylen 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.
- Background: PubMed 8203431DeLancey 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.
- Background: PubMed 8108659Petros 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.
- Background: PubMed 20236751Fritel 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.
- Background: PubMed 22999088Hermieu 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.
- Background: PubMed 15977259Messelink 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.
- Background: PubMed 23725579Deffieux 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.
- Background: PubMed 18204797Miller 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.
- Background: PubMed 21566065Hung 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.
- Background: PubMed 10074990Schaer 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.
- Background: PubMed 16978276Balmforth 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.
- Individual participant dataSharing planned: No
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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.
Clemence Tomadesso, PhD study chair
University Hospital of Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing perineal ultrasound in people with Urinary Incontinence,Stress and Ultrasound, run by University Hospital, Caen at 1 site in France.
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 13 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: status not confirmed, as of the sponsor's last update on 5 Sep 2021. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Cecile Pizzoferrato, MD (+33682176675, acpizzofe@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder neck descent reliability before PFMT (time frame: 2 years). The study lists 6 primary outcomes in all. 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 NCT04361890, which also lists 34 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 5 Sep 2021.