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iMEA : Comparison of Micro-innervation and Muscle Microstructure of the Anal Levator Muscle Between Patients With Urogenital Prolapse and Those Who Are Asymptomatic

NCT03947164 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-06-24

No results posted yet for this study

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.

Conditions

  • Prolapse Genital

Interventions

OTHER

biopsy

For cases and controls, before the intervention : a questioning, clinical symptoms of POPs and urinary incontinence, a detailed clinical examination, and an urodynamic assessment (in case of POPs) and an ultrasound guided MEA biopsy. Patients will be seen on post-operative visits between 15 days and 2 months after surgery for an examination and clinical examination.

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • 02.99.28.43.21 Nyangoh Timoh, MD · Rennes University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-17
Primary Completion
2023-05-12
Completion
2024-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03947164 on ClinicalTrials.gov