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

Not yet recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

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 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

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
Intervention / Treatment
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

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

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

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

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)

November 15, 2026

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

August 17, 2026

First Submitted That Met QC Criteria

November 8, 2026

First Posted (Actual)

November 12, 2026

Study Record Updates

Last Update Posted (Actual)

November 12, 2026

Last Update Submitted That Met QC Criteria

November 8, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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