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Investigation of the Efficacy of Different Treatment Approaches on Sexual Health in Healthy Women

Primary Purpose

Pelvic Floor Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Relaxation training with device
Home Exercise
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Floor Disorders focused on measuring woman's health, exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Healthy adults aged 18 and over Having an active sex life Exclusion Criteria: Latex allergy Other allergies in the pelvic area Vaginal or urinary tract infection Gynecological cancer

Sites / Locations

  • Medipol hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Device Group

home exercise

Arm Description

Sexual Information and Advice to Individuals Individuals in both groups will be given training on sexuality. Male and female sexual situation, orgasm, male and female anatomical structures will be explained. At the same time, information will be given about the pelvic floor muscles, their function and their importance in sexual life.

A home exercise program including pelvic floor relaxation exercises in different positions will be created for individuals in both groups and self-myofascial massages will be taught. At the same time, information will be given about the pelvic floor muscles, their function and their importance in sexual life.

Outcomes

Primary Outcome Measures

Female Sexual Function Scale
This scale was developed by Rosen et al. It has been developed by in the United States of America and its main purpose is to address female sexual function in a multifaceted manner. It has been shown to be a valid and reliable diagnostic tool in analyzing sexual functions in Turkish women. FSFI; It consists of 19 questions in total. Scale; There are 6 sub-dimensions: desire, arousal, lubrication, orgasm, satisfaction and pain. Each item is scored from zero to 5. Accordingly, the highest raw score that can be obtained from the scale is 95.0 and the lowest raw score is 4.0.
Female Sexual Stress Scale
This scale was first developed in 2002 in the United States by Derogatis, Pyke, McCormack, Hunter, and Harding to assess women with sexual dysfunction. When filling out the scale, women are asked to describe the frequency of discomfort with the sexual problem they have experienced in the last 30 days. In the society where this 13-item 5-point Likert-type scale was developed, women who score 11 and above are considered to have sexual disorders.
Surface electromyography
With the help of this measurement technique, which contains important information about the contraction of our body muscles, it is checked which muscles are activated in which movement. In our study, muscle activation evaluation will be made with the evaluation of the pelvic floor muscles.

Secondary Outcome Measures

Sexual Life Quality Scale- Female:
Each item is expected to be answered by considering the sexual life in the last four weeks. Each question is scored between 1 and 6 in the scoring of the scale. The range of points that can be obtained from the scale is between 18 and 108. A high score from the scale indicates that the quality of sexual life is good.

Full Information

First Posted
December 19, 2022
Last Updated
February 18, 2023
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05665686
Brief Title
Investigation of the Efficacy of Different Treatment Approaches on Sexual Health in Healthy Women
Official Title
Investigation of the Efficacy of Different Treatment Approaches on Sexual Health in Healthy Women
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2023 (Actual)
Primary Completion Date
April 5, 2023 (Anticipated)
Study Completion Date
August 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Sexual health is one of the important factors affecting the quality of life and general health of individuals. Sexual life, with its personal and social aspects, is an inseparable part of the human being in general. It is one of the most important factors in human life and happiness, especially in family life. Sexuality positively integrates and enriches the somatic, emotional, intellectual and social aspects of individuals, and develops a personality, communication and love. The concepts of sexuality and sexual health have long been considered taboo. This situation negatively affects rehabilitation strategies. Studies are known to have sexual problems in women more than men.
Detailed Description
There are many factors that affect sexual function. In the etiology of female sexual dysfunction; neurogenic, vascular, hormonal, musculogenic and psychogenic factors are included. If female sexual dysfunction causes distress, it negatively affects women's quality of life. The repetition of problems related to sexual response, pain, orgasm and desire, which cause interpersonal problems and discomfort, creates a complex problem. Pelvic floor muscles are known to play an important role in sexual function as they are responsible for involuntary rhythmic contractions during orgasm and vaginal sensation during intercourse. Studies have reported that pelvic floor disorders affect one-third of adult women and significantly reduce their quality of life. Different treatment methods applied to the pelvic floor muscles increase the level of muscle strength and muscle activation. Increasing pelvic floor muscle strength affects individuals' sexual life positively and reduces the problems encountered. Conservative treatment modalities include exercises for the pelvic floor muscles, functional electrical stimulation, and surface electromyography. Exercise practices are one of the important approaches that strengthen the pelvic floor muscles. These exercise approaches can be given in the form of home exercise applications, as well as device-assisted applications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders
Keywords
woman's health, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Device Group
Arm Type
Experimental
Arm Description
Sexual Information and Advice to Individuals Individuals in both groups will be given training on sexuality. Male and female sexual situation, orgasm, male and female anatomical structures will be explained. At the same time, information will be given about the pelvic floor muscles, their function and their importance in sexual life.
Arm Title
home exercise
Arm Type
Active Comparator
Arm Description
A home exercise program including pelvic floor relaxation exercises in different positions will be created for individuals in both groups and self-myofascial massages will be taught. At the same time, information will be given about the pelvic floor muscles, their function and their importance in sexual life.
Intervention Type
Device
Intervention Name(s)
Relaxation training with device
Intervention Description
Relaxation training will be applied with the device.
Intervention Type
Other
Intervention Name(s)
Home Exercise
Intervention Description
An exercise application including home exercise programs will be performed for six weeks.
Primary Outcome Measure Information:
Title
Female Sexual Function Scale
Description
This scale was developed by Rosen et al. It has been developed by in the United States of America and its main purpose is to address female sexual function in a multifaceted manner. It has been shown to be a valid and reliable diagnostic tool in analyzing sexual functions in Turkish women. FSFI; It consists of 19 questions in total. Scale; There are 6 sub-dimensions: desire, arousal, lubrication, orgasm, satisfaction and pain. Each item is scored from zero to 5. Accordingly, the highest raw score that can be obtained from the scale is 95.0 and the lowest raw score is 4.0.
Time Frame
six weeks
Title
Female Sexual Stress Scale
Description
This scale was first developed in 2002 in the United States by Derogatis, Pyke, McCormack, Hunter, and Harding to assess women with sexual dysfunction. When filling out the scale, women are asked to describe the frequency of discomfort with the sexual problem they have experienced in the last 30 days. In the society where this 13-item 5-point Likert-type scale was developed, women who score 11 and above are considered to have sexual disorders.
Time Frame
six weeks
Title
Surface electromyography
Description
With the help of this measurement technique, which contains important information about the contraction of our body muscles, it is checked which muscles are activated in which movement. In our study, muscle activation evaluation will be made with the evaluation of the pelvic floor muscles.
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
Sexual Life Quality Scale- Female:
Description
Each item is expected to be answered by considering the sexual life in the last four weeks. Each question is scored between 1 and 6 in the scoring of the scale. The range of points that can be obtained from the scale is between 18 and 108. A high score from the scale indicates that the quality of sexual life is good.
Time Frame
six weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adults aged 18 and over Having an active sex life Exclusion Criteria: Latex allergy Other allergies in the pelvic area Vaginal or urinary tract infection Gynecological cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HAZAL genç, PhD
Phone
05413204291
Email
hazaloksuz@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
sümeyye tunç, PhD
Email
sumeyye.ttunc@gmail.com
Facility Information:
Facility Name
Medipol hospital
City
Istanbul
ZIP/Postal Code
34070
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HAZAL genç, phd

12. IPD Sharing Statement

Citations:
PubMed Identifier
33162291
Citation
Salazar de Pablo G, De Micheli A, Nieman DH, Correll CU, Kessing LV, Pfennig A, Bechdolf A, Borgwardt S, Arango C, van Amelsvoort T, Vieta E, Solmi M, Oliver D, Catalan A, Verdino V, Di Maggio L, Bonoldi I, Vaquerizo-Serrano J, Baccaredda Boy O, Provenzani U, Ruzzi F, Calorio F, Nosari G, Di Marco B, Famularo I, Molteni S, Filosi E, Mensi M, Balottin U, Politi P, Shin JI, Fusar-Poli P. Universal and selective interventions to promote good mental health in young people: Systematic review and meta-analysis. Eur Neuropsychopharmacol. 2020 Dec;41:28-39. doi: 10.1016/j.euroneuro.2020.10.007. Epub 2020 Nov 6.
Results Reference
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Investigation of the Efficacy of Different Treatment Approaches on Sexual Health in Healthy Women

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