Sexual DysfunctionNCT06539897
Effectiveness of Pelvic Floor Exercises and Sexual Education in Women Over 60
A study testing Sexual education in people with Sexual Dysfunction and Menopause, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Dysfunction, Menopause, Pelvic Floor Disorders
- What is being tested?
- Sexual education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Aug 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being in the age range of 60 and above
- Having good verbal communication skills
- Willing to participate in the study
Who cannot join
- Having severe musculoskeletal impairment
- Having a psychiatric disorder
- Having a neurogenic bladder
- Having malignancy in pelvic organs
- Having cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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).
- Conditions
- Sexual Dysfunction, Menopause, Pelvic Floor Disorders
- Being tested
- Sexual education
- Medical subject headings
- Sexual Dysfunction, Physiological, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sexual education |
| No education | No intervention | Women are not given information about sexual function |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start2 Aug 2024
- Primary completion15 Aug 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alime Buyuk, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539897
- Sponsor's protocol ID
- TBAEK-398
- Status last verified
- Apr 2025
- First submitted
- 2 Aug 2024
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19656535Kikuchi 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.
PubMed 17412488Berman 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.
PubMed 12107542Wright 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.
PubMed 25841603Berman 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.
PubMed 16391543Mouritsen 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.
PubMed 19440779Deliktas Demirci A, Buyuk A, Kabukcuoglu K. Effects of positive sex education and pelvic floor strengthening program on sexual and pelvic health among youngest old: a randomized controlled trial. BMC Geriatr. 2025 Jul 3;25(1):488. doi: 10.1186/s12877-025-06152-9.
PubMed 40611002
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pelvic Floor Exercises and Sexual Education in Women Over 60: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06539897
- Acronym / sponsor ID
- TBAEK-398
- Conditions
- Sexual Dysfunction, Menopause, Pelvic Floor Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sexual Education Group | Experimental | Behavioral: Sexual educationThe 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 intervention | –Women are not given information about sexual function |
Who may qualify
- Ages
- 60 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being in the age range of 60 and above
- Having good verbal communication skills
- Willing to participate in the study
Key exclusion criteria (5 listed)
- Having severe musculoskeletal impairment
- Having a psychiatric disorder
- Having a neurogenic bladder
- Having malignancy in pelvic organs
- Having cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sexual educationThese 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. | Behavioural | Sexual Education Group |
Primary outcome
Pelvic Floor Impact Questionnaire (PFIQ-7)
Time frame: 1 week
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.
The Sexual Quality of Life-Female (SQOL-F)
Time frame: 1 week
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.
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
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.
The Sexual Self-Esteem Inventory for Women (SSEI-W)
Time frame: 1 week
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Results publication: PubMed 19656535Espuna-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.
- Results publication: PubMed 17412488Kikuchi 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.
- Results publication: PubMed 12107542Berman 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.
- Results publication: PubMed 25841603Wright 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.
- Results publication: PubMed 16391543Berman 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.
- Results publication: PubMed 19440779Mouritsen 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.
- Derived from this study: PubMed 40611002Deliktas Demirci A, Buyuk A, Kabukcuoglu K. Effects of positive sex education and pelvic floor strengthening program on sexual and pelvic health among youngest old: a randomized controlled trial. BMC Geriatr. 2025 Jul 3;25(1):488. doi: 10.1186/s12877-025-06152-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sexual education in people with Sexual Dysfunction and Menopause, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Floor Impact Questionnaire (PFIQ-7) (time frame: 1 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06539897, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.