Current Perspectives in Vaginal Laxity Measurement: A Scoping Review

This scoping review aimed to identify and categorize the available measurement options for vaginal laxity (VL), their indications of use, and whether these measurements can sufficiently provide objective clinical judgment for cases indicated for vaginal rejuvenation with many treatment options nowadays. Systematic searches were conducted on five electronic databases, manually searching articles' bibliographies and predetermined key journals with no date or study design limitations. We included all studies involving VL in their inclusion criteria, treatment indications, and outcome parameters. We used the Arksey and O'Malley frameworks as the guideline in writing this scoping review. Of the 9,464 articles identified, 66 articles and 11,258 subjects were included in the final analysis. The majority of studies were conducted in obstetrics and gynecology (73%), followed by plastic surgery (10%), medical rehabilitation (4.5%), dermatology (4.5%), and others (8%). Most studies originated from the North American region (30%). The following measurement tools were used: (1) interviews, (2) questionnaires, (3) physical/digital examinations, (4) perineometers, and (5) others. Our results suggested that subjective perception of laxity confirmed by directed interview or questionnaire is sufficient to confirm VL. Additional evaluation of pelvic floor muscle through digital examination or perineometer or other preferred tools and evaluation of sexual function through validated questionnaire (Female Sexual Function Index, Female Sexual Distress Scale-Revised, etc.) should follow to ensure holistic care to patients. Future research on the psychometric properties (reliability and validity) of commonly used measurements and the correlation in between subjective and objective measurements should be initiated before their clinical applications.


Introduction
Vaginal laxity (VL), or loosening of the vagina, is often underreported by almost 80% of women. 1,2The presence of VL complaints may be accompanied by significant problems in women's sexuality and further disturb their sense of well-being. 2,3Qureshi et al reported a prevalence of VL as 1 in 6 women attending a plastic surgery center. 4Similarly, Dietz et al reported a prevalence of 24% of patients reporting VL in their urogenital clinic. 5Even if it is common and raises some concerns, many societies still consider women with complaints of loosening of the vagina as taboo. 3urgical and nonsurgical aesthetic treatments for VL are gaining more popularity lately. 3,6However, this rising trend is not accompanied with similar patient awareness of VL condition itself.Patients often come to consultation with no prior realization of their own state of laxity.It is common for patients to ask their doctor regarding the appropriate timing for vaginal rejuvenation, the exact indications, or whether it is necessary to be done.A previous survey among women aged 25 to 45 years old who had at least one vaginal delivery and changes in vaginal tone or sensitivity reported that these women did not know how to articulate their experience of VL, did not know the validation of their problem, concerned of being dismissed or misunderstood, yet 50% of which were interested in a nonsurgical vaginal tightening procedure. 7lastic surgeons suited to provide treatments for genital rejuvenation may expect to see more of these patients, thus laxity should be properly addressed based on scientifically proven measurements and validated instruments that justify symptoms and treatment indications. 8eterogeneous patient assessment tools are available in the market based on various theoretical bases and physician judgment. 8Weighting the potential of growth yet heterogeneity in this field, we deemed it necessary to identify and scope the available measurement options for VL.Therefore, we decided to conduct a scoping review that differs from a systematic review.It explores rather than summarizes the evidence.A scoping review is considered a systematic approach to charting and mapping broad evidence into simplified categorizations. 9This study undertakes a scoping review of research to identify and categorize available measurement options for VL, the indications, and whether these measurements can sufficiently provide objective clinical judgment for cases indicated for vaginal rejuvenation with many treatment options nowadays.Additionally, we aimed to establish their roles in vaginal rejuvenation.

Methods
We followed the Arksey and O'Malley framework for this scoping review.This framework was one of the first published guidelines for scoping reviews and has been widely used.The Arksey and O'Malley framework described five stages to conducting a scoping review with a goal primarily to identify gaps in the existing literature: (1) identifying the research question, (2) identifying relevant studies, (3) study selection, (4) charting the data, and (5) collecting, summarizing, and reporting the results (►Fig. 1). 9 The first stage involved establishing the research questions.Then, we directly conducted a systematic search of three different sources (five electronic databases, manually searching articles' bibliographies, and predetermined key journals).The identified articles were extracted and deduplicated using the Mendeley Reference Manager.Next, we used Rayyan, a Web-based tool that accommodates the simultaneous title and abstract screening process for the two authors. 10All studies involved VL as their inclusion criteria, treatment indication, or outcome parameters.No limitations on the year of publication and study design were applied, as we aspired to find a broad level of evidence for this review.Exclusion criteria were as follows: review studies, treatment guidelines, duplicated studies, and studies that did not express their intention to diagnose or evaluate VL.Two authors independently reviewed the studies, and any disagreement was resolved through discussion.Complete searching strategies can be seen in ►Fig.2.
The final articles were then extracted into a predetermined worksheet in Microsoft Excel with the following details: study (author, year, design, country of origin), population (doctor-in-charge's specialty, subject of study), number of subjects, VL-related measurements, and other assessments.From which, we discovered the measurement options for VL: (1) interviews, (2) questionnaires, (3) physical/digital examinations, (4) photograph evaluations, (5) perineometers, and (6) others.Finally, a thorough quality analysis was conducted for each measurement.

Study Selection and Characteristics
The primary search identified 9,464 articles, with 66 final articles and 11,258 subjects included in the final analysis (►Supplementary Table S1, available in the online version).The articles were dated from 2009 to 2021 and written in English.In line with our inclusion criteria, all studies had to include VL measurement, whether it was presented as a primary or secondary outcome.
In addition to the questionnaire that explicitly evaluated VL (►Table 2), we also found other questionnaires that evaluated symptoms often associated with VL.Complaints regarding sexual function were evaluated using the Female Sexual Function Index (FSFI), Female Sexual Distress Scale-Revised (FSDS-R), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12, Sexual Satisfaction Questionnaire, Stabbatsberg self-rating scale, McCoy Female Sexuality Questionnaire, and ICIQ -Female Sexual Matters Associated with Lower Urinary Tract Symptoms (ICIQ-FLUTSSex).Urinary incontinence was evaluated using the Incontinence Impact Questionnaire-7, ICIQ -Urinary Continence Short Form, ICIQ-FLUTSSex, and Questionnaire of Urinary Incontinence Diagnosis.The Pelvic Floor Disability Index-20 was used to evaluate bowel, bladder, and pelvic symptoms collectively.

Physical Examination
Five studies included physical examination as a method of VL measurement. 29,62,65,68,69Three studies used physical examination to evaluate symptom severity, 29,62,68 three studies used the examination for treatment evaluation by comparing the examination during pre-and posttreatment, 62,65,69 and one study used a digital examination for VL diagnosis 69 (►Table 4).

Photograph Evaluation
A standardized photograph procedure was chosen by the authors usually to define reliable and comparable visual information.Mitsuyuki et al applied standardized photograph guidance to take before and after pictures.Then, an external independent evaluator determined which picture was the before/after for each patient and evaluated the degree of improvement using a Likert scale (0 ¼ no change, 1 ¼ mild, 2 ¼ moderate, 3 ¼ excellent change). 51Mortiers et al stated that their method of objective evaluation using Photo Analysis for Diagnosing Open Vagina is reliable, reproducible, and valid for diagnosing open vagina or vaginal gaping.They took photographs of the vaginal opening (horizontal and vertical diameters and surface area) during rest, the Valsalva maneuver, and during pelvic floor contraction. 50Meanwhile, the study by Watanabe et al was only obtained as a part of a  Vaginal Laxity Measurement Aulia, Valeria 457 conference abstract and mentioned before-after vaginal opening pictures as a mode of treatment effect evaluation, without further details on photography guides. 70

Perineometer
A total of five studies with 294 subjects used a perineometer to evaluate the treatment effect on pelvic floor muscle (PFM) pressure (►Table 5). 28,40,45,63,68A perineometer can be used to evaluate maximum and average PFM pressure, the maximum duration of the vaginal squeeze, and PFM endurance.

Discussion
This study is the first scoping review ever conducted on measuring VL and may represent a comprehensive coverage of literature discussing VL over the past decade (2009-2021).

Subjective Measurement of Vaginal Laxity as a Symptom of Pelvic Floor Dysfunction
VL is a symptom of pelvic floor dysfunction that can be evaluated by subjective exploration, which varies from conducting interviews, utilizing validated questionnaires focusing on both VL symptoms and sexual function, to conducting digital examinations.Supported by a review article by the International Continence Society and International Urogynecological Association about terminologies for female pelvic floor dysfunction, VL was grouped under symptoms of sexual dysfunction, described as patients' complaint of excessive laxity of the vagina. 73Forty-nine studies in this review also evaluated VL based solely on medical interviews and/or questionnaires. 73uestionnaire is the most common assessment tool used for VL measurement.These questionnaires assess the presence of VL, either alone or in combination with one or more symptoms related to sexual, genitourinary, or gastrointestinal problems, in a scale-like form.Some validated questionnaires evaluating VL are the ICIQ-VS, [38][39][40][41][42] ePAQ-PF, 1 and QUDOVVF. 49,50Despite the validated questionnaires mentioned above, a nonvalidated questionnaire, VLQ, has been used most often to report the symptoms and severity of VL.It has also been used to evaluate treatment indications and VL (pr-treatment) Examination by using two fingers in which subjects were asked to squeeze these fingers to the highest degree possible in a lithotomy position.When the pressure tone could not be maintained for 3 seconds, VL was confirmed (posttreatment) Confirmation of normal size of vaginal opening with two fingers able to be inserted into the vagina

VL diagnosis and treatment evaluation
by different authors originating from multiple regions.The VLQ was first designed by Millheiser et al as a subjective tool to acquire subjects' perceptions of the level of VL/tightness using seven levels as responses (Likert's scale): very loose, moderately loose, slightly loose, neither loose nor tight, slightly tight, moderately tight, or very tight.The subjects' own perception of vaginal tightness/looseness was based on their own recall of status prior to vaginal deliveries. 197][48] These questionnaires help not only to confirm VL but also to measure the degree of severity, which is important for future treatment evaluation. 62Based on our review, VLQ is sufficient to measure VL symptoms and the degree of bother subjectively.

Vaginal Laxity and Its Relation to Pelvic Floor Muscle Function and Measurement
VL as a symptom may indicate disease or disruption to a normal anatomical or histological state that usually involves dysfunction in PFM.Signs accompanying the symptoms of VL should be explored when necessary.Trauma related to vaginal deliveries, especially with episiotomy and multiparity, is often correlated with damage to the levator ani muscle and causes the perception of increased VL and reduced PFM efficiency. 32eanwhile, hyperdistensibility or any disruptions to the levator ani muscle function may cause VL. 74 Khajehei et al reported vaginal looseness in 55% of women with a history of vaginal delivery with episiotomy. 27This theory is the basis of PFM evaluation and treatment focusing on VL.Vaginal Laxity Measurement Aulia, Valeria 459 PFM function can be qualitatively evaluated by the tone at rest and strength during voluntary/reflex contraction.A validated grading system can categorize PFM strength into strong, normal, weak, or absent by digital palpation, electromyography, perineometer, or ultrasound. 73Digital palpation based on compression created on the assessor's fingers was found in four studies in this review. 29,62,68,69However, the method of examination and interpretation of the degree of symptom further varied between studies.In addition to digital palpation, other methods of PFM evaluation include objective measurements using external tools that quantify muscle pressure, electrical activities, or calculation based on images.Perineometers were used in all five studies for treatment evaluation to evaluate the before-after progression of PFM strength. 28,40,45,63,68No studies set any cutoff pressure that may indicate as problematic and in need of intervention.Meanwhile, VTI and VBA are other tools to evaluate PFM strength and vaginal tightening based on pressure sensors.VTI can also combine and create a biomechanical mapping and visualization of the vagina and pelvis structures. 72In VBA, a probe is attached to a camera to allow direct visualization of the vaginal wall. 71sEMG has also been mentioned in literature as a method to evaluate PFM function; unfortunately, surface electrodes are nonselective due to the large surface area. 75Another imaging device, 4D-TLUS, is used to record and assess the topography of the pelvis and vagina, therefore diagnosing levator avulsion and hyperdistension. 32,46,54,55hotograph evaluation was used by Mortiers et al and Mitsuyuki et al in their studies to evaluate vaginal introitus through visual inspection. 50,51Diagnosing VL using photographs, as described by Mortiers et al, 50 is reliable, reproducible, and valid.Photograph evaluation can also be combined with a Likert-like scale to observe the degree of improvement after treatment applications. 51Another important finding from the study correlated validated questionnaire to validated photograph evaluation and showed that objective findings often do not correlate with subjective complaints; finding of VL through photographs was not accompanied by subjective complaints of VL, and women complaining of VL did not always have VL based on the photographs. 50ginal Laxity and Its Relation to Sexual Dysfunction VL often becomes noticeable to women and/or partners during sexual intercourse, resulting in sexual dysfunction.Confirmed by the FGDs conducted by Kingsberg and Millheiser and Millheiser et al, apart from being subjectively perceived, VL causes significant distress, especially to subjects' emotions and sexual function. 7,67Changes in VL are related to a decrease in vaginal diameter and frictional forces during intercourse, which is responsible for decreased sexual satisfaction. 4,45Hence, it seems plausible to have sexual function evaluation prior to and after treatment.However, assessment of VL should be compulsory even before the sexual function evaluation.Presented in this review are some commonly used validated questionnaires, such as the FSFI, FSDS-R, and many others, as presented in ►Table 3.
Through measurement of both laxity and sexual function, suitable candidates for vaginal rejuvenation procedures and the treatment indications and targets would be made clear for both surgeons and patients, whether it is laxity that they want to repair, sexual function, or both.
In the future, routine vaginal examination prior to rejuvenation may include: (1) subjective validation of VL through directed interview or validated questionnaire (VLQ, VFNRS, etc.), (2) PFM evaluation through digital examination or perineometer or other preferred tools, and (3) sexual function evaluation through validated questionnaire (FSFI, FSDS-R, etc.).Further research on the psychometric properties (reliability and validity) of these measurements should be initiated before their clinical application in practice.In addition, studies focusing on finding the correlation between objective and subjective findings would create more justification for clinical practices.Though may be perceived similarly, VL is different with pelvic organ prolapse (POP) and genitourinary syndrome of menopause (GSM).The definition of POP clearly requires the presence of vaginal wall prolapse, which is not always present in VL.Additionally, a study by Alexander et al could not find any evidence of an early symptom of POP. 54VL is also different from GSM in a sense that it is comprised of symptoms associated most commonly with postmenopausal hormonal changes in estrogen, including changes beyond laxity. 76

Note
This paper was accepted for the Oral Presentation and presented at the PRS Korea 2021 (November 12-14, 2021).

Fig. 2
Fig. 2 Flowchart of article identification, screening, selection, and inclusion.Article inclusion based on the Preferred Reporting Items for Systematic Review and Meta-analyses (PRISMA) 2020 guidelines.

Table 3
Interviews that suggest VL Abbreviations: POP, pelvic organ prolapse; VL, vaginal laxity.aIt was not stated clearly in text whether the sexual sensation was considered as a part of VL diagnosis or accompanying condition.Archives of Plastic Surgery Vol.50 No.5/2023 © 2023.The Author(s).

Table 4
Physical examination Examination by using two fingers in which subjects were asked to squeeze these fingers to the highest degree possible in a lithotomy position• Light degree: strong pressure and could last more than 3 seconds • Moderate degree: less pressure lasting from 1-3 seconds.•Severedegree: nearly no pressure on 2 fingers and only a little pressure on 3 or more fingers (post-treatment) Confirmation of normal size of vaginal opening if two fingers can be inserted into the vagina Examination using fingers to determine degree of VL• Slightly loose: at least 2 fingers were required to feel the vaginal tightness during bimanual examination • Moderately loose: at least 3 fingers were required to feel the vaginal tightness during bimanual examination • Very loose: 4 or more fingers were required to feel the vaginal tightness

Table 6
Imaging and histological assessment