iMEA : Comparison of Micro-innervation and Muscle Microstructure of the Anal Levator Muscle Betwe… (NCT03947164) | Clinical Trial Compass
CompletedNot Applicable
iMEA : Comparison of Micro-innervation and Muscle Microstructure of the Anal Levator Muscle Between Patients With Urogenital Prolapse and Those Who Are Asymptomatic
France21 participantsStarted 2019-07-17
Plain-language summary
Pelvic organ prolapse (POP) is defined by the International Continence Society (ICS) as a downward displacement of one or several of the followings: "the anterior wall of the vagina", "the posterior wall of the vagina" or "the cervix".
Principal risk factor of the POP is the muscular trauma of the Levator Ani Muscle (LAM) or pelvic nerve injury during vaginal delivery and pregnancy. The POP is a real public health problem. Nearly a quarter of the female population will be affected by this pathology during their lifetime. Also, the POP is responsible for impaired quality of life. POP management is mainly surgical. The LAM is classically described as a striated muscle. In an anatomic study based on female human fetuses, it has been described a new representation of nerve supplying LAM innervation with both autonomic and somatic participation. In a second study, it has been observed within the LAM, a visceral medial area (interface with the pelvic viscera) composed of smooth muscle cells under autonomic nervous control and a lateral parietal area (interface with the bone basin) composed of striated muscle cells under somatic control. Because of the medial localization of these smooth muscle areas, it is hypothesed that the visceral medial zone within the LAM plays a major role in pelvic status maintaining.
The main goal is to compare the proportion of smooth muscle cells within the MEA in patients with urogenital prolapse and in asymptomatic ones.
The secondary objectives are:
* To compare the expression of neurotransmitters within smooth muscle cell areas in patients with POPs and asymptomatic patients.
* To compare the proportion of striated muscle cells in MEA in patients with POPs and asymptomatic patients.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Case :
\- Patient operated at Rennes University Hospital of anterior POP and / or posterior POP via vaginal and / or abdominal way.
POPs will be classified in stages 2-4 using the ICS classification;
* Without urinary incontinence associated effort (eliminated by the interrogation);
* Registered to a health insurance system;
* Having received information on the protocol and giving informed written consent.
Control :
For each case, a witness will be included with matching on the 5 year age group and parity (0, at least one child). It will be :
* Patient operated at the Rennes University Hospital for a vaginal or abdominal hysterectomy for a benign reason.
* No POPs and no urinary incontinence eliminated during the interrogation and clinical examination.
* Registered to a health insurance system;
* Having received information on the protocol and giving informed written consent.
Exclusion Criteria:
Case and Control : Exclusion criteria:
* Pregnant or lactating women
* Patients with pelvic endometriosis, pelvic gynecological cancer, history of hysterectomy.
* Major person subject to legal protection (safeguard of justice, guardianship, tutorship), deprived of liberty.
* Participation in another research involving the interventional human person or at minimal risk and constraint
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.