Clinical trial NCT06294197: Examination of the Effects of Pelvic Floor Exercises on Vaginal and Sexual Health in Postmenopausal Women.
Official title: Examination of the Effects of Pelvic Floor Exercises on Vaginal and Sexual Health in Postmenopausal Women.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sexual Dysfunction
Postmenopausal Symptoms
Pelvic Floor Muscle Weakness
Keywords: Postmenopause
vagina
vaginal dryness
sexual function
dyspareunia
quality of life
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Randomized Healthy Participants
Primary purpose: TREATMENT

Brief summary: The purpose of this study; To investigate the effects of pelvic floor muscle exercises on vaginal and sexual health in postmenopausal women. Vaginal symptoms such as vaginal dryness, burning and dyspareunia occur in the postmenopausal period. Vaginal symptoms affect sexual function, leading to a decrease in quality of life. In our study, we plan to evaluate vaginal dryness, one of the vaginal symptoms, using Schirmer's Test. Also in our study; Severities of vaginal dryness, burning and dyspareunia will be evaluated with the visual analog scale (VAS), sexual function will be evaluated with the Post-Menopausal Sexuality Questionnaire and Female Sexual Function Scale, vaginal aging will be evaluated with the Daily Effect of Vaginal Aging Scale, and the presence/severity of pelvic floor symptoms will be evaluated with the Pelvic Floor Distress Inventory-20. The cases will be randomized into two groups and pelvic floor exercises will be given to one group. After the exercises are given, vaginal pH and moistness will be evaluated for acute effect. In the other group, vaginal PH and moisture will be measured after 5 minutes. The cases will be followed without any intervention to the control group. After 12 weeks, the same evaluations will be made to both groups and the results will be compared. The data will be compared using appropriate statistical methods (statistical significance value will be taken as p\<0.05) and discussed with the literature.

Detailed description: The World Health Organization defines menopause as the permanent cessation of menstruation due to excessive loss of follicular parts (1). "Menopause" terminologically refers to the last menstrual cycle. The "postmenopause" period follows the last menstrual cycle and continues to restrict the 12-month period of amenorrhea (2). During the menopausal period, signs and symptoms of formation may occur in structures sensitive to care (labia major/minor, clitoris, introitus, vagina, urethra and environments). These signs and symptoms include normal dryness, irritation of the vulva or vagina, vulvar and vaginal warmth such as burning, smearing, decreased lubrication during sexual activity and dyspareunia and postcoital bleeding, sexual reproduction such as decreased arousal and orgasm, and urinary problems such as incontinence, dysuria, frequent stopping and urgency. It contains sections (3). Approximately 50% of postmenopausal women are greatly affected in terms of both quality of life and vital functionality (4,5). Topical hormonal therapy is normally considered standard treatment for postmenopausal women. It ensures the epithelial integrity of women and the restoration and vaginal proliferation of the vaginal flora. Prescription of topical risks should also be avoided in patients with breast cancer, susceptible tumors and a history of thromboembolism; This situation emphasizes the necessity of treatment alternatives (6,7). Lubricants and moisturizers are options to help with drying, but sufficient data to screen for effectiveness have not been published (7). It is another alternative to ospemifene and breaks down the divisions depending on your hypoestrogen (8). Fractional CO 2 laser is an emerging treatment option for vaginal care, especially for women with contraindications to hormone therapy. Fractional CO 2 laser treatment consists of two or three sessions, and treatment responses only occur after a period of 20 weeks (9). Another treatment approach is pelvic floor exercises. Pelvic floor muscle training (PFMT) was first described as an effective method of urinary incontinence management by Arnold Kegel in 1948 (10). Although Kegel reports reported over 84% recovery rates for patients after PFMT, it remained the first-stage treatment approach until the 1980s. Following this payment, women's incontinence, health and sports opportunities, the cost of surgeries, the paths opened by the surgical route, services and the permanent deterioration of the recurrences that occur after surgery, and the interest in conservative treatments also come (11). In many systematic reviews, PFMT is considered to be the first step in the treatment of urinary incontinence (12,13). A recent single-arm feasibility study found a 12-week pelvic floor muscle training (PFMT) program, a normal symptom of postmenopausal bleeding with urinary incontinence and significant bursts. After the intervention, increased secretions in normal walls, thicker vaginal epithelial cells, and improvement in vaginal color were achieved. In other words, postmenopausal pelvic floor exercises increase vaginal secretions and restore normal size (14).

The purpose of this process is; To investigate the normal and sexual health status of pelvic floor exercises after menopause. In addition, generally normal behaviors were evaluated by observing them subjectively (9,15). In our study, we plan to evaluate normal dryness, which is one of the normal conditions, using the Schirmer Test. Additionally, our study will be the first to evaluate normal dryness of a lens.

Eligibility criteria: Inclusion Criteria:

* Having applied to Istanbul Training and Research Hospital, Gynecology and Obstetrics Polyclinic
* Being literate
* Volunteering to participate in the study
* Amenorrhea for 12 months
* Being sexually active
* BMI \< 35
* Mini Mental Test Score threshold value for individuals over 65 years of age is 24

Exclusion Criteria:

* Active vaginal infection
* Having a history of active malignancy and receiving radiotherapy and/or chemotherapy accordingly
* Having received Hormone Replacement Therapy within the last year,
* Use of local estrogen
* Coitus in the last two days
* Pelvic organ prolapse stage 2 or higher
* Having had mesh surgery
* Presence of a disease/medication that causes vaginal dryness (e.g. Sjögren's syndrome, Lichen planus, Lichen Sclerosis / use of antidepressants or antihistamines).

Primary outcomes:
measure: Schirmer's Test
timeFrame: 5 minutes
Secondary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 3 minutes
measure: Female Sexual Function Index (FSFI)
timeFrame: 10 minutes
measure: Postmenopausal Sexuality Questionnaire (PMSQ)
timeFrame: 10 minutes
measure: Vaginal Daily Impact of Aging Scale (VDIAS)
timeFrame: 10 minutes
measure: Disturbing Pelvic Floor Inventory-20
timeFrame: 10 minutes
measure: Evaluation of Pelvic Floor Muscle Strength
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Training and Research Hospital
state: Fatih
Study officials:
affiliation: Hacettepe University
name: Hatice Gülşah KÜRNE, MsC
role: STUDY_CHAIR
References: