Examination of the Effects of Pelvic Floor Exercises on Vaginal and Sexual Health in Postmenopausal Women.

NCT ID: NCT06294197

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-13
• Study Completion Date: 2024-12-13

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.

Conditions

Sexual Dysfunction; Postmenopausal Symptoms; Pelvic Floor Muscle Weakness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pelvic Floor Exercises

In the intervention types, women are given training on pelvic floor exercises, that they can perform in the form of home exercises for 12 weeks. Before starting pelvic floor exercises therapy, a physiotherapist who specializes in pelvic floor compatibility will provide information about the location of the pelvic floor muscles through anatomical models and their effect on healthy, vaginal and sexual function. The effects of pelvic floor exercises on this system will be explained on an individual basis, and normal palpation is required to demonstrate their correct execution of contraction of the pelvic floor muscles. Participants will be taught how to contract and contract different muscles, such as the abdominal muscles, hip muscles, and gluteal muscles, or how to avoid pelvic tilt during contraction, and how to perform both rapid and sustained contractions.

Group Type: EXPERIMENTAL

Pelvic Floor Exercises

Intervention Type: OTHER

In the intervention types, women are given training on pelvic floor exercises, that they can perform in the form of home exercises for 12 weeks. Before starting pelvic floor exercises therapy, a physiotherapist who specializes in pelvic floor compatibility will provide information about the location of the pelvic floor muscles through anatomical models and their effect on healthy, vaginal and sexual function. The effects of pelvic floor exercises on this system will be explained on an individual basis, and normal palpation is required to demonstrate their correct execution of contraction of the pelvic floor muscles. Participants will be taught how to contract and contract different muscles, such as the abdominal muscles, hip muscles, and gluteal muscles, or how to avoid pelvic tilt during contraction, and how to perform both rapid and sustained contractions.

Control

No intervention will be made in the control unit.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pelvic Floor Exercises

In the intervention types, women are given training on pelvic floor exercises, that they can perform in the form of home exercises for 12 weeks. Before starting pelvic floor exercises therapy, a physiotherapist who specializes in pelvic floor compatibility will provide information about the location of the pelvic floor muscles through anatomical models and their effect on healthy, vaginal and sexual function. The effects of pelvic floor exercises on this system will be explained on an individual basis, and normal palpation is required to demonstrate their correct execution of contraction of the pelvic floor muscles. Participants will be taught how to contract and contract different muscles, such as the abdominal muscles, hip muscles, and gluteal muscles, or how to avoid pelvic tilt during contraction, and how to perform both rapid and sustained contractions.

Intervention Type: OTHER

Other Intervention Names

Pelvic Floor Muscle Training

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hatice Gulsah Kurne

OTHER

Sponsor Role: lead

Responsible Party

Hatice Gulsah Kurne

Student

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hatice Gülşah KÜRNE, MsC

Role: STUDY_CHAIR

Hacettepe University

Locations

Istanbul Training and Research Hospital

Istanbul, Fatih, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Hatice Gülşah KÜRNE, MsC

Role: CONTACT

kurne.gulsah@gmail.com

+905416006326

Türkan Akbayrak, Prof

Role: CONTACT

takbayra@yahoo.com

+905326587236

Facility Contacts

Nebahat Uzunay, MD

Role: primary

nebahatuzunay@gmail.com

+905052609436

Other Identifiers

PhD Thesis

Identifier Type: -

Identifier Source: org_study_id