University of Healt Science, Kartal Dr. Lutfi Kirdar City Hospital
Istanbul, Kartal, 34846, Turkey (Türkiye)
NCT Number: NCT07048145
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–75 year
Female
Interventional
Not applicable
Istanbul, Kartal, 34846, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Time frame: Baseline and 6 weeks
Change in urinary incontinence severity as measured by the Sandvick Severity Index from baseline to 6 weeks.
Time frame: At baseline and after 6 weeks
Percentage of participants who completed at least 80% of the prescribed exercise sets over the 6-week period, based on self-reported tracking forms.
Time frame: At baseline and after 6 weeks.
Participant-reported acceptability of the intervention, including comfort, willingness to continue, and perceived benefit. Data collected via structured feedback form at week 6.
sahra sultan kara
Other Gov
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
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