Model of Vaginal Laxity (MVL)

November 8, 2026 updated by: Sun Xiuli, Peking University People's Hospital

Construction of Diagnostic Model for Vaginal Laxity

This study is a multicenter, prospective cohort study. The main purpose of the study is to construct diagnostic model for vaginal laxity.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The main purpose of the study is to construct diagnostic model for vaginal laxity based on multimodal clinical data. Besides, for the enrolled patients, we conducted follow-up for those whose vaginas could accommodate more than two fingers. According to the treatment methods they received, they were divided into three groups: Patients in Group 1 underwent pelvic floor muscle exercises, those in Group 2 received physical therapy, and those in Group 3 underwent surgical treatment. This grouping is based on clinical routine diagnosis and treatment opinions. It only observes the improvement effect of vaginal relaxation in patients of different groups and does not conduct any additional interventions on the patients. Therefore, this study is an observational study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female patients who visited the gynecology outpatient department of the participating project hospital from September 2026 to September 2027.

Description

Inclusion Criteria:

  1. Women over the age of 18 who have sex
  2. Understand and voluntarily sign the written informed consent form.

Exclusion Criteria:

  1. Gynecological examination confirmed the presence of stage III or above pelvic organ prolapse
  2. There is cognitive impairment, unable to understand the content of the questionnaire or cooperate to complete the transvaginal ultrasound examination

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group 1: Pelvic floor muscle training

For patients whose vaginas can accommodate more than two fingers, if they undergo pelvic floor muscle exercises, they will be assigned to Group 1.
Behavioral: Pelvic floor muscle training

pelvic floor muscle training
Group 2: physical therapy

For patients whose vaginas can accommodate more than two fingers, if they receive physical therapy, including laser, radiofrequency, and biofeedback, they will be classified into Group 2.
Other: Physical treatment

laser treatment
Group 3: Surgery

For patients whose vaginas can accommodate more than two fingers, if they receive surgeries, they will be classified into Group 3.
Procedure: surgery

surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Construction of diagnostic model for vaginal laxity
Time Frame: From enrollment to the end of treatment at 12 months

Integrating multi-model indicators to construct gold standard diagnostic model for vaginal laxity, including age (year), weight (kg), height (m), gravidity, parity, vaginal tactile imaging, pelvic floor ultrasound, POP-Q points, modified oxford muscle strength, female sex function index (FSFI), International Consultation on Incontinence Questionnaire (ICIQ), Pelvic Floor Distress Inventory-20(PFDI-20) and Overactive bladder symptom score (OABSS)
From enrollment to the end of treatment at 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Severity of overactive bladder
Time Frame: From enrollment to the end of treatment at 12 months

Overactive bladder symptom score (OABSS) questionnaire will be used to assess the severity of overactive bladder
From enrollment to the end of treatment at 12 months
Sex function
Time Frame: From enrollment to the end of treatment at 12 months

Female sex function index (FSFI) questionnaire will be used to assess sex function
From enrollment to the end of treatment at 12 months
Severity of pelvic floor dysfunction
Time Frame: From enrollment to the end of treatment at 12 months

Pelvic Floor Distress Inventory-20 (PFDI-20) questionnaire will be used to assess severity of pelvic floor dysfunction
From enrollment to the end of treatment at 12 months
Severity of lower urinary tract symptom
Time Frame: From enrollment to the end of treatment at 12 months

International Consultation on Incontinence Questionnaire (ICIQ) will be used to assess severity of lower urinary tract symptom
From enrollment to the end of treatment at 12 months
Subjective degree of vaginal laxity
Time Frame: From enrollment to the end of treatment at 12 months

The vaginal laxity questionnaire (VLQ) will be used to assess subjective degree of vaginal laxity
From enrollment to the end of treatment at 12 months
Sexual satisfaction
Time Frame: From enrollment to the end of treatment at 12 months

The sexual satisfaction questionnaire (SSQ) will be used to assess sexual satisfaction
From enrollment to the end of treatment at 12 months
Patients' satisfaction for the treatment
Time Frame: From enrollment to the end of treatment at 12 months

Patient Global Impression of Improvement (PGI-I) will be used to assess patients' satisfaction for the treatment.
From enrollment to the end of treatment at 12 months
Severity of pain
Time Frame: From enrollment to the end of treatment at 12 months

Visual Analogue Scale (VAS) will be used to assess the severity of pain
From enrollment to the end of treatment at 12 months
Urodynamic test
Time Frame: From enrollment to the end of treatment at 12 months

Urodynamic tests were performed for free uroflowmetry, post-void residual urine volume, and cystometry in the sitting position. In free uroflowmetry, the maximum flow rate (Qmax), average flow rate (Qave), and flow time were recorded, while bladder volumes were measured during the filling cystometry test at the patient's first sense, first desire, and strong desire for urination. Besides, we paid attention to whether detrusor overactivity (DO) was noted during filling cystometry. The detrusor pressure at maximum flow (PdetQmax) and the maximum urethral closure pressure (MUCP) were also measured
From enrollment to the end of treatment at 12 months
Pelvic floor ultrasound
Time Frame: From enrollment to the end of treatment at 12 months

Bladder neck position, uterine descent, bladder neck descent, cervical position, retrovesical angle, rectal ampulla descent, bladder neck opening, urethral rotation angle, levator hiatus area, anorectal angle (ARA), puborectalis muscle integrity, perineal body thickness, perineal body length will be recorded.
From enrollment to the end of treatment at 12 months
Vaginal tactile imaging
Time Frame: From enrollment to the end of treatment at 12 months

The images from the vaginal tactile imaging will be collected.
From enrollment to the end of treatment at 12 months
Maximum vaginal capacity index
Time Frame: From enrollment to the end of treatment at 12 months
From enrollment to the end of treatment at 12 months
Modified oxford muscle strength
Time Frame: From enrollment to the end of treatment at 12 months
From enrollment to the end of treatment at 12 months
Pelvic organ prolapse quantification (POP-Q)
Time Frame: From enrollment to the end of treatment at 12 months
From enrollment to the end of treatment at 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety of surgery
Time Frame: From enrollment to the end of treatment at 12 months

The following relevant data will be collected: the duration of the surgery, the amount of bleeding, the changes in hemoglobin levels before and after the surgery, the length of hospital stay, whether there was any intraoperative organ damage, and postoperative urinary retention.
From enrollment to the end of treatment at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PKUPH-VL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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