Effectiveness of Pelvic Floor Exercises and Sexual Education in Women Over 60

NCT ID: NCT06539897

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-02

Study Completion Date

2024-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sexual Dysfunction Menopause Pelvic Floor Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Sexual education

Intervention Type BEHAVIORAL

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.

No education

Women are not given information about sexual function

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sexual education

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

60 Years

Maximum Eligible Age

74 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Alime Buyuk

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alime Buyuk

Antalya, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 19656535 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17412488 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12107542 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25841603 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16391543 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19440779 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TBAEK-398

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.