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

Pelvic Floor Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05665686
• Other study ID #: Sexual Health
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2023
• Est. completion date: August 25, 2023

Study information

• Verified date: February 2023
• Source: Istanbul Medipol University Hospital
• Contact: HAZAL genç, PhD
• Phone: 05413204291
• Email: hazaloksuz[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 25, 2023
• Est. primary completion date: April 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Floor Disorders

Intervention

Device:
• Relaxation training with device
Relaxation training will be applied with the device.

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

Locations

Country	Name	City	State
Turkey	Medipol hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	six weeks
Primary	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.	six weeks
Primary	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.	six weeks
Secondary	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.	six weeks