Urinary DysfunctionNCT07048145
Effects of Kegel Ball and Pelvic Floor Exercises on Sexual Function, Unrınary Incontinence and Quality of Life in Women
A study testing Vaginal Kegel Exercise Ball and Pelvic Floor Muscle Training in people with Urinary Dysfunction and Vaginal Prolapse, run by sahra sultan kara at 1 site in Turkey (Türkiye).
Trial summary
Urinary incontinence and sexual dysfunction are common conditions that can significantly impact quality of life. Although surgical and medical treatments are available, many individuals seek non-invasive alternatives. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Urinary Dysfunction, Vaginal Prolapse, Sexual Function Scores
- What is being tested?
- Vaginal Kegel Exercise Ball and Pelvic Floor Muscle Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Oct 2024to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Women aged 18 or over
- Suffer from stress urinary incontinence, mixed urinary incontinence, urge incontinence or urgency.
- Being sexually active
- Experience vaginal laxity and/or decreased sexual sensation for a period of 6 weeks or more.
- Understand Turkish to be able to self-complete the questionnaires (validated in Turkish ).
Who cannot join
- • Not giving informed consent.
- Has had prior surgery for incontinence, prolapse or vaginal tightening
- Has had more than 3 urinary tract infections in the past 12 months
- Is currently taking any medication for incontinence
- Is pregnant or trying to become pregnant
- Has given birth less than 6 weeks prior to enrollment
Show all 12Show fewer
- Has been diagnosed obese - BMI > 40
- Has a history of neurological conditions - Parkinson's, multiple sclerosis and other
- Women with faecal incontinence.
- Women with grade IV prolapse.
- Women who have perineal pain that makes it impossible to apply the spheres.
- Not being committed to complying with a minimum of 80% of the treatment.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Healt Science, Kartal Dr. Lutfi Kirdar City Hospital
Istanbul, Kartal, 34846
About this study
Official title: Effects of Pelvic Floor Muscle Exercises and Kegel Exercise Ball Utilization on Sexual Function, Urinary Incontinence and Quality of Life in Women With Pelvic Floor Muscle Weakness: A Randomized Controlled Trial
Urinary incontinence and sexual dysfunction are common conditions that can significantly impact quality of life. Although surgical and medical treatments are available, many individuals seek non-invasive alternatives.
Pelvic floor muscle training, also known as Kegel exercises, aims to strengthen the pelvic muscles that support the bladder and other pelvic organs. The use of vaginal Kegel balls may enhance the effects of these exercises by promoting increased muscle activation and pelvic awareness.
Read more
Preliminary findings suggest that regular pelvic floor muscle training may improve urinary control and enhance sexual function through improved muscle strength and proprioception.
This study aims to investigate the effectiveness of pelvic floor muscle exercises and Kegel ball utilization as non-invasive options for improving pelvic health, urinary continence, and sexual well-being.
A total of 40 female participants with pelvic floor muscle weakness, urinary incontinence, and sexual dysfunction will be enrolled. All participants will undergo a physical examination. Muscle strength will be assessed using the Modified Oxford Scale, and prolapse levels, if present, will be determined using the Simplified POP-Q classification. Sociodemographic data will be collected, and participants will complete three face-to-face questionnaires.
The Sandvick Severity Index (SSI) will be used to assess the severity of urinary incontinence. The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), a validated questionnaire, will assess incontinence-related quality of life. The Female Sexual Function Index (FSFI), another validated instrument, will be used to assess sexual dysfunction.
Participants will be randomized by drawing from closed envelopes containing 20 cards labeled "0" and 20 labeled "1." Those who draw a "0" will be assigned to the control group and will perform pelvic floor Kegel exercises. Those who draw a "1" will be assigned to the study group, which will perform the same exercises as the control group, along with the use of a vaginal Kegel exercise ball.
All participants will receive a 6-week home-based exercise program targeting both fast-twitch (Type II) and slow-twitch (Type I) pelvic muscle fibers. The program will include fast and slow contractions, with imagery and analogies to improve comprehension. For fast contractions, the "open-close the tap" analogy will be used. For slow contractions, participants will be instructed to "squeeze while counting to five, hold for five, and relax for five," with the visualization of an elevator slowly ascending, stopping, and descending.
Each exercise set will consist of ten rapid and ten slow contractions. Participants will be instructed to perform five sets per day during the first three weeks and increase to ten sets per day in the last three weeks. This equates to a total of 50 rapid and 50 slow contractions daily in the initial phase, increasing to 100 of each by the end of the intervention.
Exercise tracking forms will be provided to allow participants to monitor compliance and document each completed session.
Participants in the study group will be given a pelvic Kegel exercise ball to use. This device is 13.5 cm in total length, with a 3.5 cm ball width, weighs approximately 90 grams, and is made of medical-grade silicone. It contains two inner jiggle balls designed to generate passive vibrations against the vaginal wall during movement, potentially stimulating pelvic muscle activity.
After receiving instruction on safe usage, participants in the study group will wear the Kegel ball for 30 minutes daily during the first three weeks, and for one hour daily during the final three weeks, while engaging in light daily activities such as walking or household movements. They will continue to perform the same exercises as the control group while integrating the device into their routine.
- Conditions
- Urinary Dysfunction, Vaginal Prolapse, Sexual Function Scores, Kegel Exercises, Cystocele and Incomplete Uterovaginal Prolapse, Sexual Dysfunctions, Psychological
- Being tested
- Vaginal Kegel Exercise Ball, Pelvic Floor Muscle Training
- Keywords
- pelvic floor muscle training, kegel exercise, vaginal ball, weighted ball, vaginal cones, urinary dysfuntion, sexual dysfunction
- Medical subject headings
- Uterine Prolapse, Cystocele, Sexual Dysfunctions, Psychological, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal Kegel Exercise BallDevice
A 90-gram medical-grade silicone device with internal jiggle balls used intravaginally for 30 minutes daily in the first 3 weeks and 1 hour daily in the final 3 weeks.
Pelvic Floor Muscle TrainingBehavioural
Participants will perform daily Kegel exercises for 6 weeks, starting with 5 sets per day and increasing to 10 sets per day in the final 3 weeks. Each set consists of 10 fast and 10 slow contractions.
| Study group | Role | What they receive |
|---|---|---|
| Kegel Exercises + Vaginal Kegel Ball | Experimental | Participants in this group will perform the same pelvic floor muscle training program as the control group, and additionally use a vaginal Kegel exercise ball during daily activities for passive pelvic stimulation. Receives: Behavioral: Pelvic Floor Muscle Training |
| Kegel Exercises Only | Active comparator | Participants in this group will perform a structured 6-week pelvic floor muscle training program consisting of fast and slow contractions without the use of any device. Receives: Device: Vaginal Kegel Exercise Ball |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Female Sexual Function Index (FSFI) Score
Change in total FSFI score from baseline to week 6. FSFI is a validated questionnaire assessing sexual function in women, including domains of desire, arousal, lubrication, orgasm, satisfaction, and pain.
Measured: Baseline and 6 weeks
Change in International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score
Change in ICIQ-SF score from baseline to week 6. ICIQ-SF assesses frequency, severity, and impact of urinary incontinence on quality of life. Higher scores indicate greater severity.
Measured: Baseline and 6 weeks
Change in Sandvick Severity Index (SSI) Score
Change in urinary incontinence severity as measured by the Sandvick Severity Index from baseline to 6 weeks.
Measured: Baseline and 6 weeks
Secondary outcomes (2)
Adherence to Exercise Program
Percentage of participants who completed at least 80% of the prescribed exercise sets over the 6-week period, based on self-reported tracking forms.
Measured: At baseline and after 6 weeks
Feasibility and Acceptability
Participant-reported acceptability of the intervention, including comfort, willingness to continue, and perceived benefit. Data collected via structured feedback form at week 6.
Measured: At baseline and after 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start2 Oct 2024
- Primary completion2 Apr 2025
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary DysfunctionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of two parallel groups: one receiving Kegel exercises alone and the other receiving Kegel exercises combined with the use of a vaginal Kegel ball.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- sahra sultan kara
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, sahra sultan kara, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048145
- Sponsor's protocol ID
- Approval Number: 2024/14/889
- Status last verified
- Jun 2025
- First submitted
- 2 Dec 2024
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lau HH, Su TH, Hwang JC. Impact of pelvic floor muscle training on sexual function in women affected by stress urinary incontinence. Sex Med. 2024 Jun 20;12(3):qfae040. doi: 10.1093/sexmed/qfae040. eCollection 2024 Jun.
PubMed 38903774Skaug KL, Engh ME, Bo K. Pelvic floor muscle training in female functional fitness exercisers: an assessor-blinded randomised controlled trial. Br J Sports Med. 2024 Apr 25;58(9):486-493. doi: 10.1136/bjsports-2023-107365.
PubMed 38413133
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pelvic Floor Muscle Exercises and Kegel Exercise Ball Utilization on Sexual Function, Urinary Incontinence and Quality of Life in Women With Pelvic Floor Muscle Weakness: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07048145
- Acronym / sponsor ID
- Approval Number: 2024/14/889
- Conditions
- Urinary Dysfunction, Vaginal Prolapse, Sexual Function Scores, Kegel Exercises, Cystocele and Incomplete Uterovaginal Prolapse, Sexual Dysfunctions, Psychological
- Keywords
- pelvic floor muscle training, kegel exercise, vaginal ball, weighted ball, vaginal cones, urinary dysfuntion, sexual dysfunction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- sahra sultan karaOther government
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 2 Apr 2025 (actual)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 2 Jul 2025 (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.
Urinary incontinence and sexual dysfunction are common conditions that can significantly impact quality of life. Although surgical and medical treatments are available, many individuals seek non-invasive alternatives.
Pelvic floor muscle training, also known as Kegel exercises, aims to strengthen the pelvic muscles that support the bladder and other pelvic organs. The use of vaginal Kegel balls may enhance the effects of these exercises by promoting increased muscle activation and pelvic awareness.
Preliminary findings suggest that regular pelvic floor muscle training may improve urinary control and enhance sexual function through improved muscle strength and proprioception.
This study aims to investigate the effectiveness of pelvic floor muscle exercises and Kegel ball utilization as non-invasive options for improving pelvic health, urinary continence, and sexual well-being.
A total of 40 female participants with pelvic floor muscle weakness, urinary incontinence, and sexual dysfunction will be enrolled. All participants will undergo a physical examination. Muscle strength will be assessed using the Modified Oxford Scale, and prolapse levels, if present, will be determined using the Simplified POP-Q classification. Sociodemographic data will be collected, and participants will complete three face-to-face questionnaires.
The Sandvick Severity Index (SSI) will be used to assess the severity of urinary incontinence. The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), a validated questionnaire, will assess incontinence-related quality of life. The Female Sexual Function Index (FSFI), another validated instrument, will be used to assess sexual dysfunction.
Participants will be randomized by drawing from closed envelopes containing 20 cards labeled "0" and 20 labeled "1." Those who draw a "0" will be assigned to the control group and will perform pelvic floor Kegel exercises. Those who draw a "1" will be assigned to the study group, which will perform the same exercises as the control group, along with the use of a vaginal Kegel exercise ball.
All participants will receive a 6-week home-based exercise program targeting both fast-twitch (Type II) and slow-twitch (Type I) pelvic muscle fibers. The program will include fast and slow contractions, with imagery and analogies to improve comprehension. For fast contractions, the "open-close the tap" analogy will be used. For slow contractions, participants will be instructed to "squeeze while counting to five, hold for five, and relax for five," with the visualization of an elevator slowly ascending, stopping, and descending.
Each exercise set will consist of ten rapid and ten slow contractions. Participants will be instructed to perform five sets per day during the first three weeks and increase to ten sets per day in the last three weeks. This equates to a total of 50 rapid and 50 slow contractions daily in the initial phase, increasing to 100 of each by the end of the intervention.
Exercise tracking forms will be provided to allow participants to monitor compliance and document each completed session.
Participants in the study group will be given a pelvic Kegel exercise ball to use. This device is 13.5 cm in total length, with a 3.5 cm ball width, weighs approximately 90 grams, and is made of medical-grade silicone. It contains two inner jiggle balls designed to generate passive vibrations against the vaginal wall during movement, potentially stimulating pelvic muscle activity.
After receiving instruction on safe usage, participants in the study group will wear the Kegel ball for 30 minutes daily during the first three weeks, and for one hour daily during the final three weeks, while engaging in light daily activities such as walking or household movements. They will continue to perform the same exercises as the control group while integrating the device into their routine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two parallel groups: one receiving Kegel exercises alone and the other receiving Kegel exercises combined with the use of a vaginal Kegel ball.
| Arm | Type | Receives |
|---|---|---|
| Kegel Exercises + Vaginal Kegel Ball | Experimental | Behavioral: Pelvic Floor Muscle TrainingParticipants in this group will perform the same pelvic floor muscle training program as the control group, and additionally use a vaginal Kegel exercise ball during daily activities for passive pelvic stimulation. |
| Kegel Exercises Only | Active comparator | Device: Vaginal Kegel Exercise BallParticipants in this group will perform a structured 6-week pelvic floor muscle training program consisting of fast and slow contractions without the use of any device. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Women aged 18 or over
Key exclusion criteria (12 listed)
- • Not giving informed consent.
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 |
|---|---|---|
| Vaginal Kegel Exercise BallA 90-gram medical-grade silicone device with internal jiggle balls used intravaginally for 30 minutes daily in the first 3 weeks and 1 hour daily in the final 3 weeks. | Device | Kegel Exercises Only |
| Pelvic Floor Muscle TrainingParticipants will perform daily Kegel exercises for 6 weeks, starting with 5 sets per day and increasing to 10 sets per day in the final 3 weeks. Each set consists of 10 fast and 10 slow contractions. | Behavioural | Kegel Exercises + Vaginal Kegel Ball |
Primary outcome
Change in Female Sexual Function Index (FSFI) Score
Time frame: Baseline and 6 weeks
Change in total FSFI score from baseline to week 6. FSFI is a validated questionnaire assessing sexual function in women, including domains of desire, arousal, lubrication, orgasm, satisfaction, and pain.
Change in International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score
Time frame: Baseline and 6 weeks
Change in ICIQ-SF score from baseline to week 6. ICIQ-SF assesses frequency, severity, and impact of urinary incontinence on quality of life. Higher scores indicate greater severity.
Change in Sandvick Severity Index (SSI) Score
Time frame: Baseline and 6 weeks
Change in urinary incontinence severity as measured by the Sandvick Severity Index from baseline to 6 weeks.
2 secondary outcomes
Adherence to Exercise Program
Time frame: At baseline and after 6 weeks
Feasibility and Acceptability
Time frame: At baseline and after 6 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Background: PubMed 38903774Lau HH, Su TH, Hwang JC. Impact of pelvic floor muscle training on sexual function in women affected by stress urinary incontinence. Sex Med. 2024 Jun 20;12(3):qfae040. doi: 10.1093/sexmed/qfae040. eCollection 2024 Jun.
- Background: PubMed 38413133Skaug KL, Engh ME, Bo K. Pelvic floor muscle training in female functional fitness exercisers: an assessor-blinded randomised controlled trial. Br J Sports Med. 2024 Apr 25;58(9):486-493. doi: 10.1136/bjsports-2023-107365.
- 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 Vaginal Kegel Exercise Ball and Pelvic Floor Muscle Training in people with Urinary Dysfunction and Vaginal Prolapse, run by sahra sultan kara 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 5 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 2 Jul 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Female Sexual Function Index (FSFI) Score (time frame: Baseline and 6 weeks). The study lists 3 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 NCT07048145, which also lists 2 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 2 Jul 2025.