Pelvic Floor DisordersNCT05665686
Investigation of the Efficacy of Different Treatment Approaches on Sexual Health in Healthy Women
A study testing Relaxation training with device and Home Exercise in people with Pelvic Floor Disorders, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- Relaxation training with device and Home Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2023to 25 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults aged 18 and over
- Having an active sex life
Who cannot join
- Latex allergy
- Other allergies in the pelvic area
- Vaginal or urinary tract infection
- Gynecological cancer
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bahceşehir University Health Center
Istanbul, 34070
About this study
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.
Read the 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.
- Conditions
- Pelvic Floor Disorders
- Being tested
- Relaxation training with device, Home Exercise
- Keywords
- woman's health, exercise
- Medical subject headings
- Pelvic Floor Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation training with deviceDevice
Relaxation training will be applied with the device.
Home ExerciseOther
An exercise application including home exercise programs will be performed for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| Device Group | Experimental | 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. Receives: Device: Relaxation training with device |
| home exercise | Active comparator | 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. Receives: Other: Home Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six weeks
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.
Measured: six weeks
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.
Measured: six weeks
Secondary outcomes (1)
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.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start5 Jan 2023
- Primary completion21 Feb 2023
- Study completion25 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hazal genc, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665686
- Sponsor's protocol ID
- Sexual Health
- Status last verified
- Feb 2025
- First submitted
- 19 Dec 2022
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33162291
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Efficacy of Different Treatment Approaches on Sexual Health in Healthy Women
- ClinicalTrials.gov ID
- NCT05665686
- Acronym / sponsor ID
- Sexual Health
- Conditions
- Pelvic Floor Disorders
- Keywords
- woman's health, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 25 Dec 2024 (actual)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device Group | Experimental | Device: Relaxation training with deviceSexual 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. |
| home exercise | Active comparator | Other: Home ExerciseA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adults aged 18 and over
- Having an active sex life
Key exclusion criteria (4 listed)
- Latex allergy
- Other allergies in the pelvic area
- Vaginal or urinary tract infection
- Gynecological cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxation training with deviceRelaxation training will be applied with the device. | Device | Device Group |
| Home ExerciseAn exercise application including home exercise programs will be performed for six weeks. | Other | home exercise |
Primary outcome
Female Sexual Function Scale
Time frame: 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.
Female Sexual Stress Scale
Time frame: 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.
Surface electromyography
Time frame: 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.
1 secondary outcome
Sexual Life Quality Scale- Female:
Time frame: six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Background: PubMed 33162291Salazar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation training with device and Home Exercise in people with Pelvic Floor Disorders, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Sexual Function Scale (time frame: six weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05665686, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.