An observational study in Vaginal Laxity, sponsored by Peking University People's Hospital. Not yet recruiting at 6 sites in China. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Peking University People's Hospital · Observational
This study is a multicenter, prospective cohort study. The main purpose of the study is to construct diagnostic model for vaginal laxity.
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.
Peking University People's Hospital is the lead sponsor of 610 studies on the registry; 248 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Female patients who visited the gynecology outpatient department of the participating project hospital from September 2026 to September 2027.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
For patients whose vaginas can accommodate more than two fingers, if they receive surgeries, they will be classified into Group 3.
Procedure: surgery
pelvic floor muscle training
laser treatment
surgery
Construction of diagnostic model for vaginal laxity
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)
Time frame: From enrollment to the end of treatment at 12 months
Severity of overactive bladder
Overactive bladder symptom score (OABSS) questionnaire will be used to assess the severity of overactive bladder
Time frame: From enrollment to the end of treatment at 12 months
Sex function
Female sex function index (FSFI) questionnaire will be used to assess sex function
Time frame: From enrollment to the end of treatment at 12 months
Severity of pelvic floor dysfunction
Pelvic Floor Distress Inventory-20 (PFDI-20) questionnaire will be used to assess severity of pelvic floor dysfunction
Time frame: From enrollment to the end of treatment at 12 months
Severity of lower urinary tract symptom
International Consultation on Incontinence Questionnaire (ICIQ) will be used to assess severity of lower urinary tract symptom
Time frame: From enrollment to the end of treatment at 12 months
Subjective degree of vaginal laxity
The vaginal laxity questionnaire (VLQ) will be used to assess subjective degree of vaginal laxity
Time frame: From enrollment to the end of treatment at 12 months
Sexual satisfaction
The sexual satisfaction questionnaire (SSQ) will be used to assess sexual satisfaction
Time frame: From enrollment to the end of treatment at 12 months
Patients' satisfaction for the treatment
Patient Global Impression of Improvement (PGI-I) will be used to assess patients' satisfaction for the treatment.
Time frame: From enrollment to the end of treatment at 12 months
Severity of pain
Visual Analogue Scale (VAS) will be used to assess the severity of pain
Time frame: From enrollment to the end of treatment at 12 months
Urodynamic test
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
Time frame: From enrollment to the end of treatment at 12 months
Pelvic floor ultrasound
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.
Time frame: From enrollment to the end of treatment at 12 months
Vaginal tactile imaging
The images from the vaginal tactile imaging will be collected.
Time frame: 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
Modified oxford muscle strength
Time frame: 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
Safety of surgery
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.
Time frame: From enrollment to the end of treatment at 12 months
Plan to share: Yes
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Sep 2028, 22 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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