An observational study in Lower Urinary Tract Symptoms, sponsored by Pierre and Marie Curie University. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-25.
Sponsored by Pierre and Marie Curie University · Observational
Among 26 studies in Lower Urinary Tract Symptoms with a site in France — 5 open to participants now, 6 under way, none of them phase 3. Lower Urinary Tract Symptoms · France.
Among the 26 studies in Lower Urinary Tract Symptoms with a site in France, this one is the 10th largest by enrollment of the 15 observational ones that give a count, is one of 6 that started in 2017, is one of 15 observational ones, and was the 8th registered.
417 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.
Browse Lower Urinary Tract Symptoms studies →5 of the 26 studies in Lower Urinary Tract Symptoms with a site in France are open now. Recruiting first, the newest first:
Centre Hospitalier Universitaire de Nīmes · Sites in France
Ages 18+ · Women only
University Hospital, Bordeaux · Sites in France
Ages 40+ · Men only
University Hospital, Lille · Sites in France
Ages 18–65
Uromedica · Sites in France, United States
Ages 22+ · Women only
University Hospital, Grenoble · Sites in France
Ages 7–25
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 59 Lower Urinary Tract Symptoms studies recruiting now, 39 (66%) set no upper age limit and 11 (19%) stop at 75 or younger; 7 take children under 18; 11 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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26 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 6 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 33 is below the median of 152 across 132 observational studies indexed under Lower Urinary Tract Symptoms.
Median enrollment 336 across the 11 interventional studies, 72 across the 15 observational. Of the 19 that completed or were terminated, 5 (26%) have results posted.
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10 of 26 have an industry lead sponsor. The 10 most frequent:
Pierre and Marie Curie University is the lead sponsor of 23 studies on the registry; none are open to participants now.
Pierre and Marie Curie University has 7 studies filed under Lower Urinary Tract Symptoms — fewer than ten, so there is no comparison to draw.
2 of the studies in Lower Urinary Tract Symptoms with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07742436University Hospital, GrenobleUrinary and Sexual Symptoms in Patients With Hirschsprung Disease | 2027-02 |
| NCT04248283UromedicaAdjustable Continence Therapy (ACT) for the Treatment of Female SUI | 2027-05-31 |
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Among the 26 studies in Lower Urinary Tract Symptoms with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The purpose of this study is to determine the best verbal instruction to obtain a PFMC and to evaluate the understanding and acceptability of the proposed instructions.
Pelvic floor muscles contraction (PFMC) is usually recommended for evaluation and treatment of pelvic floor disorders.
In clinical practice, many patients fail to achieve a voluntary PFMC and only about one-third of women perform an ideal PFMC after brief written or verbal instruction. When no PFMC is elicited, it might be explained by an anatomical or neurological issue but also by a lack of understanding of the instructions and / or poor knowledge of the anatomy. Pelvic floor muscles (PFM) evaluation may depends on the method used to elicit and assess the contraction including verbal instructions. There is no current gold standard methodology for quantifying PFM strength and the verbal instructions used to elicit the PFMC are rarely reported in the studies. There is few specific works about the instructions. One recent study report that the pattern of urethral movement is influenced by the instructions used to teach activation of the PFM in men. Another study showed that some specific instructions are most effective in eliciting a correct PFMC in women.
Thus, an appropriate verbal instruction in terms of understanding, social and cultural acceptability, taking into account the anatomical knowledge of the patients, would probably allow a better evaluation of the PFM and even a better efficacy of pelvic floor training.
The purpose of this study is to determine the best verbal instruction to obtain a PFMC and to evaluate the understanding and acceptability of the proposed instructions.
This is a prospective observational study lead in two phases in the Neurourology Department of a University Hospital.
Phase 1: survey carry out the health professionals. Members of the scientific committees of national academic societies in neuro-urology, pelvi-perineology and pelvic-floor neurophysiology would be invited to answer a questionnaire by mail. It will include open questions about the most frequently verbal instructions used to elicit a PFMC. These instructions will be collected, analysed and selected for the second phase.
Phase 2: structured interviews with patients and with non-health professional subjects.
Patients and non-health professionals subjects will be invited to answer a 3-parts questionnaire based on the gender: (i) demographic, social and medical data; (ii) evaluation of the anatomical knowledge of the perineum with a picture of the perineum and a sagittal section of the pelvic area of the corresponding sex. In the third part (iii), the participants will assess the instructions selected in the first phase according to their understanding and their acceptability (good, intermediate, poor). They finally will have to choose the best instruction i.e. which seems to be the more suitable to obtain a PFMC.
Ethics: a local ethics committee approved this study. Since it is an observational study, the participant will have a newsletter.
Patients consulting in a tertiary center in neuro-urology.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Observational study with patients over 18 years old, consulting for lower urinary tract symptoms in a tertiary center are included.
Other: Observational study
Completing a questionnaire
Description of the instructions used by the professionals
Qualitative description of the instructions and selection of the most frequent instructions.
Time frame: 1 day during the consultation
Acceptability, understanding and selection of the best instruction by the subjects
Description of the selected instructions by the subjects : their acceptability (poor / moderate / good), and understanding (poor / moderate / good) and the best instruction to obtain PFMC (among the selected instructions).
Time frame: 1 day during the consultation
Ran from Jul 2017 to primary completion in Sep 2017, 1 month.
Of 56 non-industry observational studies under Lower Urinary Tract Symptoms, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 70. This study's 1 month is below that.
Counting every sponsor, half of 61 studies reached it within 33 months; a quarter within 11 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Lower Urinary Tract Symptoms →
Pierre and Marie Curie University