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临床试验/NCT07048145
NCT07048145进行中(未招募)不适用

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

sahra sultan kara1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
40
试验地点
1
主要终点
Change in Female Sexual Function Index (FSFI) Score

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •• 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 ).

排除标准

  • •• 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
  • •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.

研究组 & 干预措施

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.

干预措施: Pelvic Floor Muscle Training (Behavioral)

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.

干预措施: Vaginal Kegel Exercise Ball (Device)

结局指标

主要结局

Change in Female Sexual Function Index (FSFI) Score

时间窗: 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 Sandvick Severity Index (SSI) Score

时间窗: Baseline and 6 weeks

Change in urinary incontinence severity as measured by the Sandvick Severity Index from baseline to 6 weeks.

Change in International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score

时间窗: 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.

次要结局

  • Feasibility and Acceptability(At baseline and after 6 weeks.)
  • Adherence to Exercise Program(At baseline and after 6 weeks)

研究者

发起方
sahra sultan kara
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

sahra sultan kara

obstetrician-gynecologist

Dr. Lutfi Kirdar Kartal Training and Research Hospital

研究点 (1)

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