NCT06539897

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

August 2, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

13 days

First QC Date

August 2, 2024

Last Update Submit

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

EXPERIMENTAL

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.

Behavioral: Sexual education

No education

NO INTERVENTION

Women 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.

Sexual Education Group

Eligibility Criteria

Age60 Years - 74 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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: 19656535BACKGROUND
  • 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.

    PMID: 17412488BACKGROUND
  • 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.

    PMID: 12107542BACKGROUND
  • 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.

    PMID: 25841603BACKGROUND
  • 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.

    PMID: 16391543BACKGROUND
  • 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.

    PMID: 19440779BACKGROUND

MeSH Terms

Conditions

Sexual Dysfunction, PhysiologicalPelvic Floor Disorders

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsPregnancy ComplicationsMale Urogenital Diseases

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

Locations