Effectiveness of Pelvic Floor Exercises and Sexual Education in Women Over 60
1 other identifier
interventional
70
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2024
CompletedStudy Start
First participant enrolled
August 2, 2024
CompletedFirst Posted
Study publicly available on registry
August 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedApril 16, 2025
April 1, 2025
13 days
August 2, 2024
April 13, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
Pelvic Floor Impact Questionnaire (PFIQ-7)
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.
1 week
The Sexual Quality of Life-Female (SQOL-F)
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.
1 week
Pelvic Floor Distress Inventory PFDI-20
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
1 week
Arizona Sexuel Experiences Scale-ASEX
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.
1 week
The Sexual Self-Esteem Inventory for Women (SSEI-W)
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
Study Arms (2)
Sexual Education Group
EXPERIMENTALThe 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.
No education
NO INTERVENTIONWomen are not given information about sexual function
Interventions
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.
Eligibility Criteria
You may qualify if:
- Being in the age range of 60 and above
- Having good verbal communication skills
- Willing to participate in the study
You may not qualify if:
- Having severe musculoskeletal impairment
- Having a psychiatric disorder
- Having a neurogenic bladder
- Having malignancy in pelvic organs
- Having cognitive impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alime Buyuk
Antalya, 07070, Turkey (Türkiye)
Related Publications (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.
PMID: 19656535BACKGROUNDKikuchi 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.
PMID: 17412488BACKGROUNDBerman 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.
PMID: 12107542BACKGROUNDWright 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.
PMID: 25841603BACKGROUNDBerman 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.
PMID: 16391543BACKGROUNDMouritsen 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.
PMID: 19440779BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
August 2, 2024
First Posted
August 6, 2024
Study Start
August 2, 2024
Primary Completion
August 15, 2024
Study Completion
September 30, 2024
Last Updated
April 16, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share