- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06539897
Effectiveness of Pelvic Floor Exercises and Sexual Education in Women Over 60
Effectiveness of Pelvic Floor Exercises and Sexual Education in Women Over 60: A Randomized Controlled Trial
Since the mid-19th century, "old age" has been increasingly recognized as a natural life stage, especially as the human lifespan extends. However, aging brings changes that negatively impact women's lives, causing diseases and lowering quality of life. Women now spend about one-third of their lives in old age. With 1.2 billion elderly women expected by 2030 (WHO), addressing aging issues is crucial for improving life quality. As life expectancy for women exceeds 80, advancements in modern and complementary medicine are making old age more bearable. Sexual health, closely tied to general health, should be considered in this context, involving both the woman and her family.
Aging leads to hormonal and muscle changes, causing pelvic floor dysfunctions such as incontinence, prolapse, constipation, and sexual dysfunction (Kikuchi, 2007). Pelvic floor muscles play a key role in sexual function, affecting lubrication, arousal, and orgasm (Berman et al., 2002; DeUgarte et al., 2004; Wright and O'Connor, 2015). Muscle tone imbalances can cause sexual pain disorders or decreased orgasm intensity and urinary incontinence (Berman et al., 2002; Berman, 2005; Mouritsen, 2009). Decreasing hormonal balance with age leads to issues like dyspareunia in women and erectile dysfunction in men (Kelley, 2018). Strategies like behavioral training and exercise can help mitigate age-related pelvic floor problems (Espunã-Pons, 2009).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Since the mid-19th century, the concept of "old age" is frequently mentioned today, as the lifespan of humans, especially women, has been extended, and it is accepted as one of the natural and normal life stages of every woman. However, some changes that occur in old age negatively affect women's lives. This situation causes many diseases to emerge and decreases the quality of life of women (Yeni, 2004). Women will spend an average of one-third of their lives, and even longer in the future, in old age. According to the World Health Organization's estimate that 1.2 billion women will be elderly in 2030, knowing old age well and being able to overcome the problems it will create is the most important condition for increasing the quality of life of women over the age of 60. Today, when the average life expectancy for women is over 80, both the developments in the traditional approach of modern medicine and complementary medical developments have begun to make old age more bearable and allow for a dynamic life. Since Sexual Health is closely related to general health, it is most appropriate to approach sexuality in old age within the scope of old age, to plan the woman's life together with her and her family, and to take into account each parameter that will affect the quality of life (Taşkın, 2000). In parallel with the developments in the field of medicine, public health and the welfare of people in the last century, women's life expectancy has also increased. Today's women spend approximately 1/3 of their lives in the climacteric and post-climacterium period. In this respect, health problems related to this period are increasingly gaining great importance.
The decreasing and changing hormonal structure and muscle tissue changes with aging bring about pelvic floor dysfunctions. Especially factors such as the decrease in the volume of muscle tissue and its replacement by fat tissue and the decrease in the amount of estrogen/testosterone cause problems such as incontinence, prolapse, constipation and sexual dysfunctions (Kikuchi, 2007). Sexual dysfunction is also a frequently encountered condition in pelvic floor disorders in elderly individuals. Pelvic floor muscles, levator ani, bulbocavernosus and ischiocavernosus muscles, which are anatomical structures that have a direct effect on sexual function, regulate motor responses during vaginal penetration and orgasm, while the strength of these muscles increases lubrication, arousal and orgasm (Berman et al., 2002; DeUgarte et al., 2004; Wright and O'Connor, 2015). Excessive tone in these muscles causes sexual pain disorders; hypotonia seen in these muscles can lead to vaginal sensitivity, decreased orgasm intensity and urinary incontinence during sexual intercourse (Berman et al., 2002; Berman, 2005; Mouritsen, 2009). Especially with age, decreasing hormonal balance causes many problems such as dyspareunia in women and erectile dysfunction in men (Kelley, 2018). It has been reported that some strategies such as behavioral training, exercise or physical activity recommendations in pelvic floor dysfunctions minimize the problems that increase with age (Espunã-Pons M, 2009).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Antalya, Turkey, 07070
- Alime Buyuk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being in the age range of 60 and above
- Having good verbal communication skills
- Willing to participate in the study
Exclusion Criteria:
- Having severe musculoskeletal impairment
- Having a psychiatric disorder
- Having a neurogenic bladder
- Having malignancy in pelvic organs
- Having cognitive impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sexual Education Group
The intervention group contains a combination of pelvic floor exercises and sexual education.
One hour of each training consists of pelvic floor exercise practice and the other hour consists of sexual health education.
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These sessions of the sexual education program aim to increase women's knowledge and awareness about their own bodies.
Women are informed about their own bodies, their identities, and the stages of sexual response, aiming to make the process clearer and more understandable.
They will be encouraged to discover what sexuality means to them, their knowledge about sexuality will be questioned, and sexual myths, if any, will be revealed, and correct information about sexual myths will be provided to normalize sexuality.
In addition, discussions will be held on the meanings of being a woman and an older woman, and women's perspectives on themselves and their self-esteem will be emphasized.
In the third session, participants will be taught effective communication techniques to improve their communication skills with their partners.
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No Intervention: No education
Women are not given information about sexual function
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pelvic Floor Distress Inventory PFDI-20
Time Frame: 1 week
|
Pelvic Floor Distress Inventory has a total of 20 questions and 3 scales (Urinary Distress Inventory, Pelvic Organ Prolapse Distress Inventory, and Colorectal-Anal Distress Inventory).
Each short-form scale demonstrates significant correlation with their long-form scales
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1 week
|
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Pelvic Floor Impact Questionnaire (PFIQ-7)
Time Frame: 1 week
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Pelvic Floor Impact Questionnaire (PFIQ): The questionnaire has 7 questions and each question has 3 separate responses.
The response to each item of satisfaction, impact and worry was rated from 3 (quite a bit) to 0 (not at all) for the PFIQ-7.
The mean value for all the answered items within the corresponding scale (possible value 0-3) was estimated, then multiplied by (100/3) to obtain the scale score, range 0-100.
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1 week
|
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The Sexual Quality of Life-Female (SQOL-F)
Time Frame: 1 week
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The Sexual Quality of Life-Female (SQOL-F) questionnaire is a short instrument that specifically assesses the relationship between female sexual dysfunction and quality of life.
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1 week
|
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Arizona Sexuel Experiences Scale-ASEX
Time Frame: 1 week
|
The ASEX scale is designed to measure five specific items identified in a comprehensive literature review as the core elements of sexual function: sexual drive, arousal, penile erection/vaginal lubrication, ability to reach orgasm, and satisfaction from orgasm.
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1 week
|
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The Sexual Self-Esteem Inventory for Women (SSEI-W)
Time Frame: 1 week
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The Sexual Esteem subscale is a part of the MSQ, and has been used widely in studies focusing on sexual esteem.
The MSQ was developed by Snell et al. to measure psychological dimensions of sexuality, including 60 items and 12 subscales: sexual self-esteem, sexual preoccupation, internal sexual control, sexual consciousness, sexual motivation, sexual anxiety, sexual assertiveness, sexual depression, external sexual control, sexual monitoring, fear of sexual relations, and sexual satisfaction.
These 12 dimensions are evaluated independently: they do not form a total score of sexual wellbeing based in all the 12 dimensions.
Therefore, utilizing only one subscale such as sexual esteem, is not statistically problematic.
The SEs consists of five items scaled from 0-4 (0=not at all, 1=slightly, 2=somewhat; 3=moderate, 4=very much).
Higher scores correspond to greater mounts of the sexual esteem level
|
1 week
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Wright JJ, O'Connor KM. Female sexual dysfunction. Med Clin North Am. 2015 May;99(3):607-28. doi: 10.1016/j.mcna.2015.01.011. Epub 2015 Mar 6.
- Espuna-Pons M, Brugulat Guiteras P, Costa Sampere D, Medina Bustos A, Mompart Penina A. [Prevalence of urinary incontinence in Catalonia, Spain]. Med Clin (Barc). 2009 Nov 14;133(18):702-5. doi: 10.1016/j.medcli.2009.06.013. Epub 2009 Aug 5. Spanish.
- Kikuchi A, Niu K, Ikeda Y, Hozawa A, Nakagawa H, Guo H, Ohmori-Matsuda K, Yang G, Farmawati A, Sami A, Arai Y, Tsuji I, Nagatomi R. Association between physical activity and urinary incontinence in a community-based elderly population aged 70 years and over. Eur Urol. 2007 Sep;52(3):868-74. doi: 10.1016/j.eururo.2007.03.041. Epub 2007 Mar 28.
- Berman JR, Bassuk J. Physiology and pathophysiology of female sexual function and dysfunction. World J Urol. 2002 Jun;20(2):111-8. doi: 10.1007/s00345-002-0281-4. Epub 2002 Jun 1.
- Berman JR. Physiology of female sexual function and dysfunction. Int J Impot Res. 2005 Dec;17 Suppl 1:S44-51. doi: 10.1038/sj.ijir.3901428.
- Mouritsen L. Pathophysiology of sexual dysfunction as related to pelvic floor disorders. Int Urogynecol J Pelvic Floor Dysfunct. 2009 May;20 Suppl 1:S19-25. doi: 10.1007/s00192-009-0831-z.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TBAEK-398
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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