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

NCT03947164 | Completed

• 2 other identifiers: 35RC18_9793_iMEA2019-A00393-54
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of smooth muscle cells

  Proportion of smooth muscle cells within MEA protrusion zones in patients with prolapse compared to prolapse-free patient

  inclusion visit

Secondary Outcomes (6)

• Immunolabeling of the parasympathetic (cholinergic) nervous system 31

  inclusion visit

• Identification of nerve fibers

  inclusion visit

• Immunolabeling of the sympathetic nervous system (noradrenergic) 31

  inclusion visit

• Immunolabeling of anti-neuronal Nitric Oxide Synthase (nNOS) 32

  inclusion visit

• Immunolabelling of the somatic nervous system anti-PMP2233

  inclusion visit

Study Arms (2)

Case group

OTHER

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.

Other: biopsy

Control group

OTHER

Control: 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.

Other: biopsy

Interventions

biopsy OTHER

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.

Case group; Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes University Hospital

Rennes, Brittany Region, 35033, France

Location

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• 02.99.28.43.21 Nyangoh Timoh, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric case-control study (1: 1). The inclusion of cases and controls will be prospective. For each case, a control will be included with matching on parity (0, at least one child). Concerning the age, they will be matched according to the following age groups: 18-39 years old, 40-44 years old, 45-49 years old, 50-54 years old, over 55 years old.

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 13, 2019
• Study Start: July 17, 2019
• Primary Completion: May 12, 2023
• Study Completion: December 31, 2024
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)