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

Sponsor
Istanbul Medipol University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05665686
Collaborator
(none)
50
1
2
6.6
7.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Relaxation training with device
  • Other: Home Exercise
N/A

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. The We Vibe Chorus device is one of these devices. It has the feature of stimulating the pelvic floor muscles with different vibration modules.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Investigation of the Efficacy of Different Treatment Approaches on Sexual Health in Healthy Women
Actual Study Start Date :
Jan 5, 2023
Anticipated Primary Completion Date :
Mar 5, 2023
Anticipated Study Completion Date :
Jul 25, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Device Group

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.

Device: Relaxation training with device
Relaxation training will be applied with the we vibe chorus device.

Active Comparator: home exercise

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.

Other: Home Exercise
An exercise application including home exercise programs will be performed for six weeks.

Outcome Measures

Primary Outcome Measures

  1. Female Sexual Function Scale [six weeks]

    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.

  2. Female Sexual Stress Scale [six weeks]

    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.

  3. Surface electromyography [six weeks]

    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

  1. Sexual Life Quality Scale- Female: [six weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medipol hospital Istanbul Turkey 34070

Sponsors and Collaborators

  • Istanbul Medipol University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
hazal genc, physiotherapist PhD, Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier:
NCT05665686
Other Study ID Numbers:
  • Sexual Health
First Posted:
Dec 27, 2022
Last Update Posted:
Jan 27, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by hazal genc, physiotherapist PhD, Istanbul Medipol University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2023