Clinical Research Directory

On the Effect of a Hybrid Health Literacy Intervention on Sexual Function and Digital Health Literacy in Menopausal Women

This randomized controlled study will evaluate whether a hybrid health literacy education program improves sexual function and digital health literacy in postmenopausal women. Hybrid education combines in-person and online sessions. The study will include 128 women aged 45-60 years who have not had a menstrual period for at least 12 months. Participants will be recruited from the gynecology and obstetrics outpatient clinic at Kahramanmaraş Sütçü İmam University Hospital in Türkiye and randomly assigned to an education group or a usual-care group, with 64 women in each group. The education group will receive a midwife-led program consisting of one in-person session and two online sessions over three weeks. The sessions will cover sexual health during menopause, finding and evaluating reliable online health information, and using this information in daily life. Women in the usual-care group will continue to receive routine health services without additional study education. Participants in both groups will complete questionnaires assessing sexual function and digital health literacy before and after the intervention period. Researchers will compare changes between the groups to assess the effects of the education program.

VEDA Study (DHEA vs Estradiol)

This study is being done to compare two vaginal treatments, vaginal estrogen and vaginal DHEA, that are used to treat vaginal and urinary symptoms related to menopause. These symptoms may include vaginal dryness, discomfort, painful intercourse, or urinary problems and can affect quality of life and sexual health. Women who choose to participate will be randomly assigned to use one of the two treatments for a set period of time. Participants will complete questionnaires about their symptoms and sexual health and have simple vaginal testing at the beginning and end of the study. The goal of this research is to better understand how these treatments affect vaginal health and sexual function so healthcare providers can make informed treatment decisions and improve care for postmenopausal women.

Effectiveness of Biofeedback-Assisted Pelvic Floor Muscle Training on Sexual Function and Quality of Life in Patient After Hysterectomy

The purpose of this study is to determine the effectiveness of biofeedback-assisted pelvic floor muscle training in improving pelvic floor muscle strength, decreasing urinary incontinence symptoms, reducing genital prolaps and enhancing the quality of life in women after hysterectomy.

Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.

The goal of this clinical trial is to retrospectively identify the most prevalent symptoms of genitourinary syndrome of menopause (GSM) among postmenopausal women and to evaluate their impact on quality of life. Moreover, based on data collected from medical records and/or patient-reported questionnaires, if available data enable it, it will be assessed whether treatment with the topical vulvovaginal gel XCM INTIM for a minimum of 8 weeks results in changes in symptom severity and in the impact of these symptoms across different quality-of-life domains.

Impact of Time on Sexual Function (FSFI® Score) After Hysterectomy

In France, more than 62 000 hysterectomies are performed each year. Female sexual function is the result of multiple psychological, social and physiological factors. There is no information in the current literature about the optimum time between the surgery and the sexual relation resumption. The primary outcome is to assess the impact of advising time between hysterectomy and sexual relation resumption by using FSFI® score. Secondaries outcomes are: to describe and compare post-operative complications in the two groups of the study, to describe the follow-up of the recommendation concerning time between surgery and sexual relation resumption and to describe why this recommendation was not followed. This study is based on 4 questionnaires: FSFI® pre-operative and post-operative, pre-operative questionnaire and post-operative questionnaire. This is a monocentric, comparative, of superiority, randomised and prospective study. Patients are randomised into two groups: sexual relation resumption advised 4 weeks after surgery, or 8 weeks. The inclusion criteria are more than 18 years, francophone, in sexual activity, scheduled for a total hysterectomy for benign indication (menometrorrhagia, fibroma, adenomyosis, endometriosis, pelvic floor disorders, low-grade endometrial cancer), considering vaginal, laparoscopic and abdominal approach, and a written consent. Non-inclusion criteria are illiteracy, cognitive disorders, without social security, deprived liberty by judicial or administrative decision, psychiatric care, patient with legal protection, patient incapable of giving consent. If our conclusions confirmed our hypothesis, it can improve clinical practices by providing additional informations for surgeon and patient, to undergo this surgery as serenely as possible.

Effect of a Therapeutic Exercise and an Education Program on Sexual Function and Experience in People With Endometriosis

This is a randomized clinical trial that will be carried out in people with endometriosis divided into two groups: the experimental group (EG) that will receive therapeutic exercise combine with sexual education, and the control group (CG) who will receive the therapeutic exercise program. The participants will be evaluated at three moments: before starting the study (T1), after the 8-week treatment program (T2) and after 4 weeks of follow-up in which they will be encouraged to continue with the treatment (T3). Objective and subjective data of the participants will be evaluated. T1 will be assessed with a sociodemographic questionnaire and the FSFI and MSSCQ surveys. T2 and T3 will assess blood pressure, heart rate, variability of the autonomic system, the ability to dissociate the lumbopelvic movement from the thoracolumbar, measurement of the muscles of the transverse, internal and external obliques, the distance between the rectus abdominis and the pelvic floor, subjective perception of effort during exercise and subjective perception of orgasmic intensity.

Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.

The goal of this clinical trial is to improve the management of Genitourinary syndrome of menopause (GSM) to preliminary assess safety and effectivity of a novel hormone-free mucosa composition (XCMIM20m) applied topically to the vulvovaginal area. Symptoms of vaginal atrophy will be compared before and after 8 weeks of use of the tested gel with the Day-to-Day Impact of Vaginal Aging (DIVA) PROMs questionnaire to assess changes impact of GSM symptoms.

Effects of Infertility and Assisted Reproductive Technology on Sexual Function and Behavior

This cross-sectional observational study examines how infertility and the use of assisted reproductive technology (ART) are related to sexual function and sexual behaviors in women seeking fertility treatment. Infertility and the stress of ART may be associated with changes in sexual desire, satisfaction, and activity. The purpose is to better understand these associations to support the sexual health and overall well-being of women undergoing fertility care. Women who are assigned female at birth, under 45 years old, diagnosed with infertility, and attending appointments at the MUHC Reproductive Centre are invited to take part. Participants will be asked to complete an anonymous questionnaire while waiting for their clinical visit. The questionnaire includes the validated Female Sexual Function Index (FSFI), which measures different aspects of sexual function, and additional questions about sexual activities, such as frequency of intercourse and other behaviors before and after fertility treatments. Participants will not provide any identifying information. Completed questionnaires will be placed in a secure collection box to protect confidentiality. Data from approximately 500 participants will be analyzed to explore how infertility type (primary vs. secondary), duration of infertility, and the number of unsuccessful ART cycles relate to sexual function and behavior. Findings from this study may help healthcare providers better recognize and address the sexual health concerns of women with infertility. This study is approved by the McGill University Health Centre Research Ethics Board (REB #2025-11459).

Effects of a Combined Program of Pelvic Floor Muscle Training and Yoga

This study aims to examine the effects of Pelvic Floor Muscle Training (PFMT) combined with yoga on relieving genitourinary symptoms, symptom-related quality of life, and improving sexual function in women with breast cancer. This study is a parallel randomized study with two groups. Women will be assigned to the experimental or control group by using the block randomization method. The experimental group will receive regular care and a 12-week program of PFMT and yoga. The control group will receive regular care. We collect relevant data from both groups at baseline and 4, 8, 12, and 24 weeks after baseline during the study period.