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

NCT06294197 | Recruiting DMC

• 1 other identifier: PhD Thesis
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Dysfunction; Postmenopausal Symptoms; Pelvic Floor Muscle Weakness

Keywords

Postmenopause; vagina; vaginal dryness; sexual function; dyspareunia; quality of life

Outcome Measures

Primary Outcomes (1)

• Schirmer's Test

  This test was developed to diagnose dry eye (16). In this study, the test will be used to evaluate vaginal dryness. Test strips (ERC) not impregnated with blue dye, 5 mm wide and 35 mm long, are used for the test. The strip will be placed in the vagina, above the Carunculae Hymenalis, by holding it with sterile forceps or by holding the very end of the strip. After the test strip placement is standardized in this way, time will be kept with a stopwatch. The test strip will be left in the vagina for 5 minutes. When the time is completed, the test strip will be removed immediately and the distance the vaginal wetness has progressed will be measured according to the values on the strip.

  5 minutes

Secondary Outcomes (6)

• Visual Analogue Scale (VAS)

  3 minutes

• Female Sexual Function Index (FSFI)

  10 minutes

• Postmenopausal Sexuality Questionnaire (PMSQ)

  10 minutes

• Vaginal Daily Impact of Aging Scale (VDIAS)

  10 minutes

• Disturbing Pelvic Floor Inventory-20

  10 minutes

Study Arms (2)

Pelvic Floor Exercises

EXPERIMENTAL

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.

Other: Pelvic Floor Exercises

Control

NO INTERVENTION

No intervention will be made in the control unit.

Interventions

Pelvic Floor Exercises 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.

Also known as: Pelvic Floor Muscle Training

Pelvic Floor Exercises

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Postmenopausal women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hatice Gulsah Kurne: lead

Study Sites (1)

Istanbul Training and Research Hospital

Istanbul, Fatih, 34098, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Dyspareunia

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Hatice Gülşah KÜRNE, MsC

  Hacettepe University

  STUDY CHAIR

Central Study Contacts

Hatice Gülşah KÜRNE, MsC

CONTACT

+905416006326; kurne.gulsah@gmail.com

Türkan Akbayrak, Prof

CONTACT

+905326587236; takbayra@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Student

Model Details: Parallel Assignment Randomized Healthy Participants

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 5, 2024
• Study Start: January 13, 2024
• Primary Completion: July 13, 2024
• Study Completion: December 13, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)