Clinical and Psychological Outcomes of the Use of Vaginal Dilators After Gynaecological Brachytherapy: a Randomized Clinical Trial (original) (raw)

Vaginal Dilators: Issues and Answers

Sexual Medicine Reviews, 2020

Introduction: Vaginal dilators are often prescribed to facilitate an adaptive brain-body connection to decrease anxiety and pain that can be experienced in anticipation of sexual intercourse among populations of women with sexual pain syndromes. Postmenopausal women, cancer survivors, and women with a wide variety of pelvic floor disorders who experience genito-pelvic pain/penetration disorder (GPPPD) are often advised to incorporate vaginal dilators into their pelvic floor rehabilitation program and treatment regimens to enable penetrative intercourse with less pain. However, little is known about the behaviors of dilator users, what treatment protocols are most effective, how patients are currently using their dilators, and how effective are clinicians in helping their patients achieve success with their dilation therapy. Methods: A recent PubMed literature search was performed using the key words vaginal dilator, vaginal dilator therapy, sexual quality of life, vaginal stenosis, vaginal dilation, vaginismus. A total of 29 English articles were reviewed and summarized. Articles were excluded for the following reasons: not in English and unrelated to dilator therapy. Main Outcome Measure: This article will summarize the current research on vaginal dilators and discuss needs for future research to maximize patients' compliance and success with this treatment. Much of the summary data regarding user behavior will come from the early survey data with Milli, a novel, patient-controlled electronic dilator that slowly expands 1 mm at a time from its smallest diameter, 15 mm to a maximum diameter of 40 mm. Milli is currently being used by more than 1,000 women, and 3-month follow-up data were recorded on 335 of those patients. Results: Dilators exist in multiple forms (plastic, latex, and medical grade material), may come individually or in sets, and many have special features such as vibration or the ability to be heated or cooled before use. Little is known about patients' use of dilators and the Milli's 3-month survey serves as an insight to patient dilator behavior. The most common medical goals for patients undergoing dilation treatment were return to penetrative intercourse and pain reduction during coitus. Patients were dilated on average 2.72 days/week; 56.8% of patients had suffered from sexual pain for 2 or more years and 36.3% had previously used static dilators. More than 70% of Milli users purchased Milli and are using Milli without the direct guidance of a clinician. The most common emotions patients used to describe their treatment were not only "anxious," "frustrated," but also "empowered" and "optimistic." The most common dilatory session duration was 6e10 minutes, mostly in the evening/bedtime (68.3%), located in the bedroom (96.8%). Adjunctive treatment included the following: vaginal moisturizers, local estrogen products, coital lubricants, and genital pelvic floor physical therapy. During the dilation sessions, women most often watched TV/videos, practiced mindfulness, or listened to soothing music. Factors that showed trends toward improved patient outcomes were length of dilation treatment (greater than 3 months) and use of meditation and soothing music. Factors not associated with improvement trends were as follows: when/ where patients dilated and patient demographics including age, race, or religious preferences. Conclusion: Patients who purchase dilators have often suffered with their condition for a long time and had difficulty finding a competent health-care clinician well versed in sexual pain syndromes that can help them. When patients did find a clinician, there were no clinically proven standardized protocols or formalized guidelines to give to patients about how to best use their dilators. Larger long-term interventions investigating a standardized dilation protocol are planned in future studies to better elucidate the effective and optimal dilation treatment plans.

Validity & Reliability of Vlosum (Het’s Device - to Instantly Test Vaginal Opening) Test the Vaginal Opening

International Journal of Research and Review

Spasmodic pelvic floor muscles can occur due to multiple reasons like stress, anxiety, recurrent urinary tract infection. The pelvic floor dysfunctions due to hypertonus pelvic floor muscles can be Vaginismus, dyspareunia, chronic pelvic pain, urinary symptoms like dysuria, incomplete voiding, lower abdominal pain associated with bladder filling, hypertonic pelvic floor muscles can also lead to issues with constipation, pelvic dyssynergia etc. The prevalence of Vaginismus and dyspareunia is very high. Yet there is no single tool which is designed to assess the pelvic floor relaxation ability. Vlosum is the world’s first device which can test and improve vaginal opening (through relaxation of pelvic floor muscles). The outcome measure taken are FSFI – Female Sexual Function Index, NPRS – Numeric Pain Rating Scale, self-reported question for anxiety about first time penetration and Vlosum. The study duration was of 18 months and 1184 women were evaluated. The participants were divided...

An update on surgical and non-surgical treatments for vaginal hypoplasia

Human Reproduction Update, 2014

vaginal capacity, complications and long-term durability in terms of sexual function) of the different surgical and non-surgical reconstruction techniques, we evaluate if vaginal dilation proposed as the first-line technique is justified based on the evidence. results: When anatomical success was defined as a length of ≥7 cm and functional success as coitus, all vaginoplasty techniques yielded significantly higher success rates (.90 versus 75% after vaginal dilation), irrespective of underlying diagnosis or start vaginal length. When functional success was defined as 'satisfaction with sex', including non-genital sex, differences disappeared. Failed dilation therapy does not preclude anatomical (nor functional) success if vaginoplasty afterwards is necessary. Traction vaginoplasty seems to have the highest anatomical (99%) and functional success rates (96%), whereas both split-and full-thickness skin graft procedures and intestinal procedures have the lowest successful outcomes (83-95%). Overall, complication rates were significantly lower within the vaginal dilation groups when compared with the different vaginoplasty techniques. Although no randomized control data exist regarding maintenance dilation, the available evidence suggests that continued dilation is needed to maintain patency in periods of coital inactivity. Despite the expectancy that the probability of further positive outcomes is maximized with psychological counselling, this could not be confirmed. conclusions: As the medical literature lacks high-quality comparative outcome studies and prospective, longitudinal studies are scarce, no evidence-based treatment guidelines can be provided. However, because of the physically low complication rate and an overall success chance of 75%, vaginal dilation as first choice treatment seems to be justified. Overall, the laparoscopic Vecchietti procedure, becoming more and more available in specialized centres, is considered an appropriate surgical option in patients who are poorly compliant and failed dilation therapy, or for those who do not want to start with vaginal dilation therapy. Future approaches need to raise a wider range of psychosexually oriented questions, elucidate the relationship between vaginal depth and satisfactory outcomes and gain additional experience concerning the format of acceptable and efficient psychological care.

Survey on Aesthetic Vulvovaginal Procedures: What do Portuguese Doctors and Medical Students Think?

Revista Brasileira de Ginecologia e Obstetrícia, 2017

Objective To assess the medical doctors and medical students' opinion regarding the evidence and ethical background of the performance of vulvovaginal aesthetic procedures (VVAPs). Methods Cross-sectional online survey among 664 Portuguese medical doctors and students. Results Most participants considered that there is never or there rarely is a medical reason to perform: vulvar whitening (85.9% [502/584]); hymenoplasty (72.0% [437/607]); mons pubis liposuction (71.6% [426/595]); "G-spot" augmentation (71.0% [409/576]); labia majora augmentation (66.3% [390/588]); labia minora augmentation (58.3% [326/559]); or laser vaginal tightening (52.3% [313/599]). Gynecologists and specialists were more likely to consider that there are no medical reasons to perform VVAPs; the opposite was true for plastic surgeons and students/residents. Hymenoplasty raised ethical doubts in 51.1% (283/554) of the participants. Plastic surgeons and students/residents were less likely to raise ethical objections, while the opposite was true for gynecologists and specialists. Most considered that VVAPs could contribute to an improvement in self-esteem (92.3% [613/664]); sexual function (78.5% [521/664]); vaginal atrophy (69.9% [464/664]); quality of life (66.3% [440/664]); and sexual pain (61.4% [408/664]). Conclusions While medical doctors and students acknowledge the lack of evidence and scientific support for the performance of VVAPs, most do not raise ethical objections about them, especially if they are students or plastic surgeons, or if they have had or have considered having plastic surgery.

Tension-free vaginal tape: Do patients who fail to follow-up have the same results as those who do?

Neurourology and Urodynamics, 2005

To compare success and complication rates of the Tension-free vaginal tape (TVT) between patients with good versus poor follow-up. Materials and Methods: A prospective cohort study of 108 women undergoing a TVT procedure was conducted. Patients were seen postoperatively at 6 weeks, 3, 6, 12 months, and yearly thereafter. Patients were categorized as poor follow-up if this schedule was not adhered to. Those who were lost to follow-up at or after their 6-week visit were considered as having failed the procedure. Results: Seventy-nine (73%) patients had good followup. Of the remaining 29 patients with poor follow-up, 12 (11%) could not be reached and 17 (16%) were contacted by phone. Reasons given for poor follow-up were: busy or live far from hospital (11), health problems (4), and dissatis¢ed from surgery (2). Perioperative complication rates were similar between the two groups (P ¼ 0.16). When patients with complete loss to follow-up were analyzed as failures, subjective and objective cure rates were signi¢cantly higher in patients with good as opposed to poor follow-up: 92 and 95% versus 72 and 69%, respectively, (P ¼ 0.006). Conclusions: Patients with poor follow-up probably have lower cure rates after TVT. It is important to follow postoperative patients closely. When reporting success rates, one has to account for all cases to produce realistic results. Neurourol. Urodynam. 24: 35^38, 2005. ß 2004 Wiley-Liss, Inc.

Do alterations in vaginal dimensions after reconstructive pelvic surgeries affect the risk for dyspareunia?

American Journal of Obstetrics and Gynecology, 2005

The purpose of this study was to determine whether changes in vaginal dimensions after transvaginal reconstructive pelvic surgeries affect the risk for postoperative dyspareunia. Study design: Charts of all sexually active patients who underwent transvaginal reconstructive pelvic surgeries in our institution between July 1998 and June 2002 with 1 year of follow-up evaluations were reviewed. Data were analyzed with the Student t, c 2 , Pearson's correlation tests and a logistic regression model. Results: Two hundred twenty-eight women aged 44 to 83 years were included. Dyspareunia increased after operation (16% vs 7%; P = .001); total vaginal length (7.6 vs 8.8 cm; P = .001) and genital hiatus (2.7 vs 3.5 cm; P = .001) dimensions significantly decreased after operation, with no predilection for any specific procedure. No correlation was found between these changes in vaginal dimensions and the risk for dyspareunia. Conclusion: The prevalence of dyspareunia increases after transvaginal reconstructive pelvic surgeries. Despite a postoperative decrease in vaginal dimensions, a causal relationship between dyspareunia and changes in vaginal dimensions may not exist.

Vaginal dilator use more than 9 months is a main prognostic factor for reducing G2‑late vaginal complications in 3D‑vaginal‑cuff brachytherapy (interventional radiotherapy)?

Clinical & Translational Oncology, 2023

Purpose Analyse the impact of different prognostic factors on G2-late vaginal complications after vaginal brachytherapy (VBT) ± external beam radiotherapy (EBRT) in postoperative endometrial cancer (PEC). Methods One hundred and twenty-six PEC patients treated with VBT ± EBRT were retrospectively analysed considering age, body mass index, applicator diameter, clinical target volume (CTV), use of dilators, chemotherapy and EQD2 (α/β=3) at the most exposed 2 cm 3 of the CTV as prognostic factors for vaginal complications. Late vaginal complications were evaluated using objective LENT-SOMA criteria. Statistics: descriptive analysis, Chi-square, Fisher and Student tests were applied. Univariate and multivariate analyses were performed with the Baptista-Pike exact method and multiple logistic regression. Results Mean age was 65 years (SD ± 10), and median follow-up was 66 months (8-104). 19/126 patients (15%) showed G2-late vaginal complications, and 107/126 (85%) G0-G1. Univariate analysis showed: CTV ≤ 9 cm 3 (p = 0.036), use of dilators < 9 months (p = 0.015), and total ≥ 68 Gy EQD2 received by 2 cm 3 of CTV (p = 0.039) were associated with G2-late vaginal toxicity. Multivariate analysis showed the use of dilators < 9 months as an independent prognostic factor for G2-late vaginal toxicity (p = 0.043, OR 8.59, CI 1.59-159.9). Conclusion The use of dilators < 9 months in VBT ± EBRT for PEC was an independent prognostic factor for G2-late vaginal toxicity. The use of vaginal dilators ≥ 9 months requires further analysis in studies evaluating late vaginal toxicity.

Ultrasound imaging to evaluate Creatsas vaginoplasty

International Journal of Gynecology & Obstetrics, 2005

Objective: To present a new imaging technique for the evaluation of the functional effectiveness of Creatsas vaginoplasty. Method: Eighteen women with Mayer-Rokitansky-Küster-Hauser syndrome underwent a transabdominal and transperineal ultrasound examination 4 weeks and 6 months after the surgical creation of a neovagina, and then yearly, with a condom filled with water as a distending and imaging medium. The functional length and width of the neovagina and its axis deviation were assessed, as well as the postoperative quality of the women's sexual life. Results: A functional vagina 10 to 12 cm in length and 4 to 5 cm in width was observed; its axis deviation, which was similar to the anatomic deviation, was easily determined; and 94.5% of the women reported a satisfactory while 5.5% reported an adequate sexual life. Conclusion: This new imaging technique is a simple and effective alternative for the evaluation of the postoperative effectiveness of colpopoiesis.

Quantitative Assessment and Interpretation of Vaginal Conditions

Sexual Medicine, 2018

Introduction: Few means exist to provide quantitative and reproducible assessment of vaginal conditions from biomechanical and functional standpoints. Aim: To develop a new approach for quantitative biomechanical characterization of the vagina. Methods: Vaginal tactile imaging (VTI) allows biomechanical assessment of soft tissue and function along the entire length of the anterior, posterior, and lateral vaginal walls. This can be done at rest, with applied vaginal deformation, and with pelvic muscle contraction. Results: Data were analyzed for 42 subjects with normal pelvic floor support from an observational casecontrolled clinical study. The average age was 52 years (range ¼ 26e90 years). We introduced 8 VTI parameters to characterize vaginal conditions: (i) maximum resistance force to insertion (newtons), (ii) insertion work (millijoules), (iii) maximum stress-to-strain ratio (elasticity; kilopascals per millimeter), (iv) maximum pressure at rest (kilopascals), (v) anterior-posterior force at rest (newtons), (vi) left-right force at rest (newtons), (vii) maximum pressure at muscle contraction (kilopascals), and (viii) muscle contraction force (newtons). We observed low to moderate correlation of these parameters with subject age and no correlation with subject weight. 6 of 8 parameters demonstrated a P value less than .05 for 2 subject subsamples divided by age (52 vs >52 years), which means 6 VTI parameters change with age. Conclusions: VTI allows biomechanical and functional characterization of the vaginal conditions that can be used for (i) understanding "normal" vaginal conditions, (ii) quantification of the deviation from normality, (iii) personalized treatment (radiofrequency, laser, or plastic surgery), and (iv) assessment of the applied treatment outcome.

A Comparison of 99 Consecutive Vaginal Reconstructions

Annals of Plastic Surgery, 2004

This study compares the outcome of Singapore flap, vertical rectus abdominis musculocutaneous flap (VRAM), and gracilis musculocutaneous flap vaginal reconstruction. A retrospective review of 99 consecutive patients with complete vaginal defects was conducted at the Mayo Clinic from January 1988 to October 2001. All possible complications were determined for each of the 3 reconstructive techniques, along with the effects of radiation and smoking on the respective complication rates. Preoperative and postoperative sexual function and adequacy were compared between each group. Ninety-nine patients ranging in age from 19 to 80 years (mean, 51.6 years) were compared, with a mean follow-up of 28.9 months. Forty-one VRAM, 13 gracilis, and 45 modified Singapore flaps were used for vaginal reconstruction. The majority was due to acquired vaginal defects due to recurrent pelvic malignancy. The overall complication rate was lower following VRAM than either gracilis or Singapore flap reconstructions (13/41, 31.7%; 8/13, 61.5%; and 21/45, 46.7%, respectively). The flap specific complication rate was least in the VRAM group (9/41, 22%; 7/13, 53.8%; and 17/45, 37.8%, respectively). The VRAM had a significant protective effect against the development of postoperative small bowel obstruction. Preoperative sexual activity predicted postoperative activity in 75 of 88 patients (85.2%) and was not affected by the type of reconstruction, although more patients with a Singapore flap required vaginal dilatation to maintain patency. In conclusion, the VRAM has a lower overall and flap-related complication rate compared with either gracilis or Singapore flap reconstruction. It has become our vaginal reconstructive flap of choice.