Published online Aug 31, 2020.
https://doi.org/10.6118/jmm.19024
Gold Thread Implantation for Female Sexual Dysfunction and Vaginal Laxity: A Preliminary Investigation
Abstract
Objectives
We evaluated the efficacy of gold thread implantation (GTI) in the vulva and vagina to improve female sexual dysfunction (FSD) and vaginal laxity.
Methods
A retrospective chart review was conducted on 46 women who underwent GTI between 2017 and 2018 at our institution. Physicians interviewed patients using questionnaires at baseline and 1–3 months post-treatment. The questionnaires consisted of eight questions: vaginal laxity, vaginal dryness, pain during intercourse, sexual satisfaction during intercourse, sexual arousal confidence, sexual satisfaction of partner, frequency, and maintaining lubrication.
Results
Overall, participants experienced significant improvement after GTI treatment (P < 0.0001). The median score of vaginal laxity was 3 (slightly loose) at baseline and 5 (slightly tight) at post-treatment. Vaginal dryness also improved from 4 (moderate) at baseline to 2 (little) at post-treatment. The degree of pain during intercourse decreased from 3 to 1. The sexual satisfaction score was 3 (moderately dissatisfied) at baseline and 4 (about equally satisfied and dissatisfied) at post-treatment. Sexual confidence of arousal increased from a score of 3 (low confidence) at baseline to 4 (moderate confidence) at post-treatment. They perceived greater partner sexual satisfaction, moving from a score of 2 to 4. Participants reported lubrication was more frequent during sexual activity, which was maintained until completion of sexual activity. Both scores regarding lubrication increased from 3.5 at baseline to 5 at post-treatment.
Conclusions
GTI may be an option for FSD and vaginal laxity.
Introduction
In recent years, there has been an increased interest in sexual health. Many women consider it an important part of their general health and life satisfaction [1, 2]. In a large scale study, 44.2% of women self-reported that they have experienced sexual problems [3]. Female sexual dysfunction (FSD) is associated with complex physiological and psychological symptoms, significantly less is understood in comparison to male sexual dysfunction [4]. FSD is defined as the various ways that a woman is unable to participate in a sexual relationship as they wish [5]. FSD was subclassified into 3 items according to The Diagnostic and Statistical Manual of Mental Disorders, the fifth edition (DSM-V); female sexual interest/arousal disorder, genitopelvic pain/penetration disorder, female orgasmic disorder [6]. FSD differs from sexual distress; the latter is defined by individual emotions about their sexuality, such as anxiety, frustration, and unhappiness [7]. The prevalence of FSD was reported to be divers, from 13.3% to 79.3% [8, 9, 10]. FSD could result from medical comorbidities, depression, stress, and aging [11].
Vaginal laxity is defined as looseness of the vaginal opening which differs from pelvic organ prolapse, which is the descent of one or more genito-pelvic structures [12, 13]. Although vaginal laxity is poorly understood, it is relatively common complaints and a survey of the International Urogynecological Association physicians reported that over 80% of their patients underreported vaginal laxity [14]. As aging progresses, reductions in vaginal wall elasticity and lubrication are common. Subsequently, sensation during intercourse is decreased and vaginal dryness or irritation occurs [15, 16]. Therefore, vaginal laxity and dryness could be one of the causes of FSD [13, 17].
There is a growing demand to improve the management of FSD; consequently, non-invasive, office-based treatments, including radiofrequency and laser therapies, are gaining popularity and becoming more readily available [13, 18]. Gold thread implantation (GTI) has been performed actively in the field of dermatology for some time, especially for skin tightening and wrinkle reduction [19, 20]. However, we lack the evaluation of GTI for FSD and vaginal laxity. To the best of our knowledge, this is the first study to investigate GTI in the field of gynecology and sexology. The objective of this study was to evaluate the efficacy of the application of GTI in the vulva and vagina to improve FSD and vaginal laxity.
Materials and Methods
Participants
A retrospective chart review was employed for 46 women who received GTI between August 2017 and December 2018. This study was approved by the Institutional Review Board (IRB) of Seoul National University Bundang Hospital (IRB No. B-1906-544-107). Women over the age of 35 years and complaining one of the following symptoms were included. Participants were asked to select all that apply: (1) vaginal laxity defined as a vaginal laxity questionnaire score ≤ 3 (n = 27, 58.7%); (2) vaginal dryness defined as a vaginal dryness score ≥ 4 (n = 25, 54.3%); (3) sexual pain defined as a pain score during intercourse ≥ 3 (n = 30, 65.2%); (4) low sexual satisfaction defined as sexual satisfaction questionnaire score ≤ 3 (n = 42, 91.3%); (5) low sexual confidence of arousal defined as sexual confidence of arousal score ≤ 3 (n = 35, 76.1%); and (6) problems of lubrication defined as the frequency of lubrication score ≤ 3 (n = 27, 58.7%) or maintaining of lubrication score ≤ 3 (n = 28, 60.9%).
Study protocol
For the assessment of treatment outcomes, physicians interviewed patients using questionnaires at baseline and 1–3 months post-treatment (Supplementary, available online). The questionnaire consisted of (1) vaginal laxity score (1 = very loose, 2 = moderately loose, 3 = slightly loose, 4 = neither loose nor tight, 5 = slightly tight, 6 = moderately tight, 7 = very tight) [13, 21]; (2) vaginal dryness score (1 = none, 2 = little, 3 = fair, 4 = moderate, 5 = severe, 6 = very severe); (3) pain score during intercourse (0–5 scale); (4) sexual satisfaction during intercourse (1 = none, 2 = very dissatisfied, 3 = moderately dissatisfied, 4 = about equally satisfied and dissatisfied, 5 = moderately satisfied, 6 = very dissatisfied) [21]; (5) sexual satisfaction of partner during intercourse (0–5 scale); (6) sexual confidence of arousal (1 = no sexual activity, 2 = very low or no confidence, 3 = low confidence, 4 = moderate confidence, 5 = high confidence, 6 = very high confidence); (7) frequency of lubrication (1 = no sexual activity, 2 = almost never or never, 3 = a few times [less than half of the time], 4 = sometimes [about half of the time], 5 = most times [more than half the time], 6 = almost always); and (8) maintaining of lubrication (1 = no sexual activity, 2 = almost never or never, 3 = a few times [less than half of the time], 4 = sometimes [about half of the time], 5 = most times [more than half the time], 6 = almost always). Questions 4, 6, 7, and 8 were extracted from the female sexual function index (FSFI) [11].
Materials and procedures
The implant material was non-absorbable, 0.07 mm diameter gold threads (Hyunseok Medical, Seoul, Korea). It spirally wrapped around the 30-gauge needle. This needle was inserted and removed, placing the gold threads in the intact tissue. Under intravenous sedation, sterile drapes were applied with the patient in a lithotomy position. Variable lengths of gold threads were employed, depending on the insertion sites − 38 mm or 50 mm for the dermis and subcutaneous layer of the labia majora; and 13 mm for the surroundings of the clitoris and labia minora; 25 mm for the vaginal introitus and walls between the lamina propria and muscular layer. 25 mm gold threads were inserted at 3, 6, 9, and 12 o'clock of the vaginal wall. The same procedure sequence was applied to all patients.
Statistical analysis
All statistical analyses were performed using IBM SPSS ver. 22 (IBM Corp., Armonk, NY, USA). The Wilcoxon signed-rank test was used to compare the scores between pre- and post-treatment. All P values < 0.05 were considered significant.
Results
Forty-six subjects received GTI. The median age and parity were 48.5 years (interquartile range, 45.0–53.3 years) and 2.0, respectively (Table 1). Two subjects who had no experience of pregnancy were included. GTI procedures were well tolerated, and there was no occurrence of procedure-related adverse events, such as vaginitis. The baseline and post-GTI scores were presented in Table 2.
Table 1
Demographics and clinical characteristics of subjects
Table 2
Changes in questionnaire scores before and after gold thread implantation (GTI)
For all variables, subjects showed significant improvement after GTI treatment. Forty-one subjects (89.1%) reported improvement of vaginal laxity. The median score of vaginal laxity was 3 (slightly loose) at baseline and 5 (slightly tight) at post-treatment (P < 0.0001). Vaginal dryness also improved from a score of 4 (moderate) at baseline to 2 (little) at post-treatment (P < 0.0001). Forty subjects (87.0%) experienced improvement of vaginal dryness. The degree of pain during intercourse, with a possible range of 0 to 5, decreased from a score of 3 to 1 (P < 0.0001).
Similarly, subjects reported improvement in sexual satisfaction and confidence of arousal during intercourse. The sexual satisfaction score at baseline was 3 (moderately dissatisfied), which increased to 4 (about equally satisfied and dissatisfied) at post-treatment (P < 0.0001). Sexual confidence of arousal was increased from a score of 3 (low confidence) at baseline to 4 (moderate confidence) at post-treatment. Moreover, they perceived greater partner's sexual satisfaction, increasing from a score of 2 to 4, with a possible range of 0 to 5 (P < 0.0001). Subjects reported that lubrication was more frequent during sexual activity or intercourse, and maintained longer until completion of sexual activity or intercourse. Both scores regarding lubrication were 3.5 at baseline and 5 at post-treatment (P < 0.0001).
Discussion
In the present study, GTI exhibited statistically significant improvements in FSD and vaginal laxity. After GTI treatment, sexual satisfaction and confidence of arousal were increased, and vaginal dryness and dyspareunia were decreased. The outpatient GTI treatment was well tolerated without the occurrence of any adverse effects.
Gold threads have been applied in various clinical settings (e.g., eyelid weight in facial palsy patients, material for odontology treatment) without substantial immunologic reactions [22]; they have even been used as additives in foods and cosmetic products. Pure gold might be a clinically-useful material that is stable, nonimmunologic, nonallergic, antibacterial, and inoffensive to the organism [23, 24]. Although gold is considered safe material, the complications associated with gold implantation have been reported after treatment for lagophthalmos, such as hypersensitivity reaction, local inflammatory reactions [25, 26].
GTI was first introduced to the field of dermatology about 50 years ago by Dr. Caux in France [27]; however, the mechanisms of GTI is poorly understood. Rondo Júnior et al. [27] performed punch biopsies on an anterior arm of 10 women after GTI. They observed the synthesis of plentiful collagen and elastic fibers without tissue rejection. They have suggested that GTI promotes skin tension through the formation of collagen and reticulin fibers. Shin et al. [19] have found that GTI might promote angiogenesis, as there were rich blood vessels in comparison to other regions. In animal studies, researchers also found the stimulated production of collagen. Kurita et al. [28] investigated the effects of lifting the threads in a rat model for over seven months. Interestingly, the amount of collagen was increased gradually throughout the study period with long-lasting tissue reactions. They concluded that GTI sustained collagen formation, which may support tissue tension for a prolonged period. Kim et al. [29] unexpectedly observed hair re-growth after GTI for facial lifting in a 38-year-old female patient. They underwent GTI on the dorsal skin of mice. They found that it induced not only hair growth but also substantial collagen deposition in the dermis. Through these findings, we could speculate that GTI in the vulva and vagina may increase collagen production and angiogenesis, ultimately promoting the elasticity and regeneration of connective tissues. As a result, FSD and vaginal laxity might be improved. Also, as neocollagenesis and neovascularization would restore the vaginal environment to a healthy state, vaginal lubrication could be improved [30]. At the same time, caution should be taken providing GTI because it is still an experimental procedure. It is important to provide enough information to the patients before GTI treatment to make an informed choice.
The limitations of this study include the retrospective nature of the work, small sample size, and short follow-up period. Further studies with large sample size are required to better elucidate the therapeutic mechanisms and long-term safety of GTI.
In conclusion, GTI may be a potential treatment for FSD and vaginal laxity by promoting collagen and elastic fiber synthesis.
CONFLICT OF INTEREST:No potential conflict of interest relevant to this article was reported.
References
-
Dawson ML, Shah NM, Rinko RC, Veselis C, Whitmore KE. The evaluation and management of female sexual dysfunction. J Fam Pract 2017;66:722–728.
-
-
American College of Obstetricians and Gynecologists and the American Urogynecologic Society; INTERIM UPDATE: This Practice Bulletin is updated as highlighted to reflect the US Food and Drug Administration order to stop the sale of transvaginal synthetic mesh products for the repair of pelvic organ prolapse. Pelvic organ prolapse. Female Pelvic Med Reconstr Surg 2019;25:397–408.
-
-
Rondo Júnior W, Vidarte G, Michalany N. Histologic study of the skin with gold thread implantation. Plast Reconstr Surg 1996;97:256–258.
-