Effects of Kegel Ball and Pelvic Floor Exercises on Sexual Function, Unrınary Incontinence and Quality of Life in Women

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.

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 Overview

• Status: Active, not recruiting
• Conditions: Sexual Dysfunctions, Psychological; Urinary Dysfunction; Vaginal Prolapse; Cystocele and Incomplete Uterovaginal Prolapse; Kegel Exercises; Sexual Function Scores
• Intervention / Treatment: Behavioral: Pelvic Floor Muscle Training; Device: Vaginal Kegel Exercise Ball

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kartal
    • Istanbul, Kartal, Turkey, 34846
      • University of Healt Science, Kartal Dr. Lutfi Kirdar City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • 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 ).

Exclusion Criteria:

• • 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kegel Exercises + Vaginal Kegel Ball; 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.	Behavioral: Pelvic Floor Muscle Training; 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.
Active Comparator: Kegel Exercises Only; 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.	Device: Vaginal Kegel Exercise Ball; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	At baseline and after 6 weeks.

Collaborators and Investigators

• Sponsor: sahra sultan kara

Publications and helpful links

General 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.
• Skaug 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2024
• Primary Completion (Actual): April 2, 2025
• Study Completion (Estimated): July 15, 2025

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: June 28, 2025
• First Posted (Actual): July 2, 2025

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 28, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: sexual dysfunction; pelvic floor muscle training; kegel exercise; vaginal ball; weighted ball; vaginal cones; urinary dysfuntion
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Male Urogenital Diseases; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Urinary Bladder Diseases; Pelvic Organ Prolapse; Sexual Dysfunctions, Psychological; Prolapse; Uterine Prolapse; Cystocele
• Other Study ID Numbers: Approval Number: 2024/14/889

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No