Model of Vaginal Laxity
NCT07933120, Not yet recruiting, Peking University People's Hospital
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Model of Vaginal Laxity | ClinicalTrials.gov |
| NCT number | NCT07933120 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 500 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Peking University People's Hospital | ClinicalTrials.gov |
| Conditions | Vaginal Laxity | ClinicalTrials.gov |
| Interventions | Pelvic floor muscle training, Physical treatment, surgery | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Construction of diagnostic model for vaginal laxity | 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) | ClinicalTrials.gov |
| Secondary | Severity of overactive bladder | 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 | ClinicalTrials.gov |
| Secondary | Sex function | From enrollment to the end of treatment at 12 months | Female sex function index (FSFI) questionnaire will be used to assess sex function | ClinicalTrials.gov |
| Secondary | Severity of pelvic floor dysfunction | 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 | ClinicalTrials.gov |
| Secondary | Severity of lower urinary tract symptom | 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 | ClinicalTrials.gov |
| Secondary | Subjective degree of vaginal laxity | 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 | ClinicalTrials.gov |
| Secondary | Sexual satisfaction | From enrollment to the end of treatment at 12 months | The sexual satisfaction questionnaire (SSQ) will be used to assess sexual satisfaction | ClinicalTrials.gov |
| Secondary | Patients' satisfaction for the treatment | 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. | ClinicalTrials.gov |
| Secondary | Severity of pain | From enrollment to the end of treatment at 12 months | Visual Analogue Scale (VAS) will be used to assess the severity of pain | ClinicalTrials.gov |
| Secondary | Urodynamic test | 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 | ClinicalTrials.gov |
| Secondary | Pelvic floor ultrasound | 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. | ClinicalTrials.gov |
| Secondary | Vaginal tactile imaging | From enrollment to the end of treatment at 12 months | The images from the vaginal tactile imaging will be collected. | ClinicalTrials.gov |
| Secondary | Maximum vaginal capacity index | From enrollment to the end of treatment at 12 months | ClinicalTrials.gov | |
| Secondary | Modified oxford muscle strength | From enrollment to the end of treatment at 12 months | ClinicalTrials.gov | |
| Secondary | Pelvic organ prolapse quantification (POP-Q) | From enrollment to the end of treatment at 12 months | ClinicalTrials.gov | |
| Other | Safety of surgery | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)