Clinical trial NCT06539897: Effectiveness of Pelvic Floor Exercises and Sexual Education in Women Over 60
Official title: Effectiveness of Pelvic Floor Exercises and Sexual Education in Women Over 60: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Dysfunction
Menopause
Pelvic Floor Disorders
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 70
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Pelvic Floor Impact Questionnaire (PFIQ-7)
timeFrame: 1 week
measure: The Sexual Quality of Life-Female (SQOL-F)
timeFrame: 1 week
measure: Pelvic Floor Distress Inventory PFDI-20
timeFrame: 1 week
measure: Arizona Sexuel Experiences Scale-ASEX
timeFrame: 1 week
measure: The Sexual Self-Esteem Inventory for Women (SSEI-W)
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Alime Buyuk
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.