Prolapse GenitaliMEANCT03947164
iMEA : Comparison of Micro-innervation and Muscle Microstructure of the Anal Levator Muscle Between Patients With Urogenital Prolapse and Those Who Are Asymptomatic
A study testing biopsy in people with Prolapse Genital, run by Rennes University Hospital at 1 site in France.
Trial 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". Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prolapse Genital
- What is being tested?
- biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jul 2019to 31 Dec 2024
- 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
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
It is a monocentric case-control study (1: 1). The inclusion of cases and witnesses will be prospective. For each case, a witness 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.
For cases and controls, before the intervention, a questioning (age, weight, height, parity, mode of delivery, hormonal status), clinical symptoms of POPs and urinary incontinence, a detailed clinical examination, and an urodynamic assessment (in case of POPs) will be noted.
All cases and controls will have an ultrasound guided MEA biopsy. A fine needle will be used. The biopsy (5mm) will interest the medial part located between the vagina and the rectum.
Patients will be seen on post-operative visits between 15 days and 2 months after surgery for an examination and clinical examination.
From the biopsy, it will be performed a classic staining (Masson's trichrome) and specific immuno-markings to detect all the nerves, and to differentiate parasympathetic autonomic, sympathetic autonomic, erectile, and somatic nerves. Immunostaining for smooth muscle, striated muscle and relaxin system will also be performed. An immunofluorescence technique will be associated. Thus, some additional slides will be reserved for an actomyosin ATPase enzymatic reaction to differentiate muscle fiber types. Treated sections will be digitized with a Hamamatsu slide scanner for subsequent image analysis and analysis. The size of the different types of striated muscle fibers (1, 2a, 2b) will be measured using the NDPview (Hamamatsu) software. The labeling surface of the different antibodies will be quantified objectively by the NIS-Elements Viewer software.
Benefits are collective :
- Clinical impact: Find new medical therapeutic targets and improve rehabilitation techniques.
- Repercussion in research:
- To set up a PHRC with a randomized controlled multicenter study on the comparison of electrical stimulation and voluntary muscular contraction in postpartum with measurement of pelvic floor muscle strength and pelvic-perineal evaluation (search for pelvic prolapse , urinary incontinence).
- To improve knowledge of anatomy and physiology of pelvic floor muscles by mapping neurotransmitters in LAM in adult patients with POPs and asymptomatic patients.
- Conditions
- Prolapse Genital
- Being tested
- biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of smooth muscle cells
Proportion of smooth muscle cells within MEA protrusion zones in patients with prolapse compared to prolapse-free patient
Measured: inclusion visit
Secondary outcomes (6)
Immunolabeling of the parasympathetic (cholinergic) nervous system 31
Immunolabeling of the parasympathetic (cholinergic) nervous system 31: Vesicular antitransporter of acetylcholine (VAChT). VAChT is a marker of neurons in cholinergic fibers, but also preganglionic protoneurons of the sympathetic system. The antibody used for this neuronal immunostaining was obtained by immunization of rabbits (Code No. V 5387) and diluted to 1 / 2000th.
Measured: inclusion visit
Identification of nerve fibers
S-100 neuronal anti-protein immuno-labeling (S-100) 30. This immuno-tagging is used to identify nerve fibers, nerve endings and their distribution. The antibody used for this neuronal immunostaining was obtained by immunization of rabbits (Code No. Z0311, Dako, Denmark) and diluted 1: 400.
Measured: inclusion visit
Immunolabeling of the sympathetic nervous system (noradrenergic) 31
Immunolabeling of the sympathetic nervous system (noradrenergic) 31: tyrosine anti-hydroxylase (TH). TH is used as a marker for dopaminergic neurons and neurons and noradrenergic fibers. The antibody used for this neuronal immunostaining was obtained by immunization of rabbits (Code No. ab112) and diluted to 1 / 750th.
Measured: inclusion visit
Immunolabeling of anti-neuronal Nitric Oxide Synthase (nNOS) 32
Immunolabeling of erectile nerves: anti-neuronal Nitric Oxide Synthase (nNOS) 32: nNOS is one of the three isoforms of NOS, an immunomarker of the autonomic nervous system that plays a role in the relaxation of smooth muscle and found mainly in the cytosols of erectile nerves attached to formalin and included in paraffin. The antibody used is directed against amino acids 1422-1433 of human nNOS 37. It was obtained by immunization of rabbits (Cayman Laboratories, Dallas, TX, Cat No.160870, 1 μg / ml) and diluted 1: 200. .
Measured: inclusion visit
Immunolabelling of the somatic nervous system anti-PMP2233
Immunolabelling of the somatic nervous system anti-PMP2233. PMP 22 is a 22 Kd glycoprotein produced by Schwann cells and expressed in the myelin sheath of the peripheral somatic nervous system. The antibody used for this neuronal immunostaining was obtained after immunization of rabbits (ref AB12220, abcam, USA) and diluted 1/100.
Measured: inclusion visit
Proportion of striated muscle cells in MEA
Proportion of striated muscle cells in MEA in patients with prolapse compared to prolapsed patients.
Measured: inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start17 Jul 2019
- Primary completion12 May 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolapse GenitalStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- 02.99.28.43.21 Nyangoh Timoh, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947164
- Sponsor's protocol ID
- 35RC18_9793_iMEA
- Other IDs
- 35RC18_9793_iMEA, 2019-A00393-54
- Acronym
- iMEA
- Status last verified
- Jun 2025
- First submitted
- 30 Apr 2019
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iMEA : Comparison of Micro-innervation and Muscle Microstructure of the Anal Levator Muscle Between Patients With Urogenital Prolapse and Those Who Are Asymptomatic
- ClinicalTrials.gov ID
- NCT03947164
- Acronym / sponsor ID
- iMEA / 35RC18_9793_iMEA
- Conditions
- Prolapse Genital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 13 May 2019 (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.
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.
Detailed description
It is a monocentric case-control study (1: 1). The inclusion of cases and witnesses will be prospective. For each case, a witness 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.
For cases and controls, before the intervention, a questioning (age, weight, height, parity, mode of delivery, hormonal status), clinical symptoms of POPs and urinary incontinence, a detailed clinical examination, and an urodynamic assessment (in case of POPs) will be noted.
All cases and controls will have an ultrasound guided MEA biopsy. A fine needle will be used. The biopsy (5mm) will interest the medial part located between the vagina and the rectum.
Patients will be seen on post-operative visits between 15 days and 2 months after surgery for an examination and clinical examination.
From the biopsy, it will be performed a classic staining (Masson's trichrome) and specific immuno-markings to detect all the nerves, and to differentiate parasympathetic autonomic, sympathetic autonomic, erectile, and somatic nerves. Immunostaining for smooth muscle, striated muscle and relaxin system will also be performed. An immunofluorescence technique will be associated. Thus, some additional slides will be reserved for an actomyosin ATPase enzymatic reaction to differentiate muscle fiber types. Treated sections will be digitized with a Hamamatsu slide scanner for subsequent image analysis and analysis. The size of the different types of striated muscle fibers (1, 2a, 2b) will be measured using the NDPview (Hamamatsu) software. The labeling surface of the different antibodies will be quantified objectively by the NIS-Elements Viewer software.
Benefits are collective :
- Clinical impact: Find new medical therapeutic targets and improve rehabilitation techniques.
- Repercussion in research:
- To set up a PHRC with a randomized controlled multicenter study on the comparison of electrical stimulation and voluntary muscular contraction in postpartum with measurement of pelvic floor muscle strength and pelvic-perineal evaluation (search for pelvic prolapse , urinary incontinence).
- To improve knowledge of anatomy and physiology of pelvic floor muscles by mapping neurotransmitters in LAM in adult patients with POPs and asymptomatic patients.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Case group | Other | Other: biopsyCase : - 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 group | Other | Other: biopsyControl: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| biopsyFor 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. | Other | Case group, Control group |
Primary outcome
Proportion of smooth muscle cells
Time frame: inclusion visit
Proportion of smooth muscle cells within MEA protrusion zones in patients with prolapse compared to prolapse-free patient
6 secondary outcomes
Immunolabeling of the parasympathetic (cholinergic) nervous system 31
Time frame: inclusion visit
Identification of nerve fibers
Time frame: inclusion visit
Immunolabeling of the sympathetic nervous system (noradrenergic) 31
Time frame: inclusion visit
Immunolabeling of anti-neuronal Nitric Oxide Synthase (nNOS) 32
Time frame: inclusion visit
Immunolabelling of the somatic nervous system anti-PMP2233
Time frame: inclusion visit
Proportion of striated muscle cells in MEA
Time frame: inclusion visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- 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.
02.99.28.43.21 Nyangoh Timoh, MD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biopsy in people with Prolapse Genital, run by Rennes University Hospital 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 12 inclusion and 5 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: finished, as of the sponsor's last update on 24 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of smooth muscle cells (time frame: inclusion visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2025.