Efficacy of the Use of Vaginal Balls for the Improvement of Urinary Incontinence and Sexual Function in Women.

Urinary Incontinence Clinical Trial

Official title:

Efficacy of the Use of Vaginal Balls for the Improvement of Urinary Incontinence and Sexual Function in Women. Randomized Control Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05732844
• Other study ID #: LAIA_bolas
• Status: Completed
• Phase: N/A
• Start date: October 5, 2022
• Est. completion date: January 27, 2023

Study information

• Verified date: February 2023
• Source: RAPbarcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Asess if adding vaginal spheres treatment to the conventional Pelvic Floor Muscle Trainning (PFMT) produces a greater decrease in the severity of the stress urinary incontinence or a greater perceived quality of life related to incontinence.

Description:

The intervention group will perform the pelvic floor muscle trainning (PFMT) plus the use of vaginal spheres, while the control group will perform the PFMT treatment only, daily at home. The study will be conducted on women with stress urinary incontinence. The intervention will last four months and will consist of a monthly session with the physiotherapist, doing a total of 4 sessions and the final assessment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 27, 2023
• Est. primary completion date: January 27, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women aged 18 or over
• Suffer from stress urinary incontinence or mixed urinary incontinence.
• Understand Spanish to be able to self-complete the questionnaires (validated in Spanish).

Exclusion Criteria:

• Not giving informed consent.
• Women with faecal incontinence.
• Women with grade III-IV prolapse.
• Women with pathology that can affect the neuro-muscular response.
• Women with incontinence that is not of functional origin.
• Women who have perineal pain that makes it impossible to apply the spheres.
• Women with an open vagina of more than 2.5 cm opening
• Being pregnant.
• Not being committed to complying with a minimum of 80% of the treatment.
• Having previously started other pelvic physiotherapy treatments

Related Conditions & MeSH terms

• Enuresis
• Sexual Dysfunction
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Intervention group with Enna pelvic ball
The home guideline for placement of the vaginal spheres will be as described in next: st-2nd week 15 minutes, 1 time a day nd-4th week 30 minutes, 1 time a day 4th-8th week 1 hour, 1 time a day 8th-12th week 2 hours, 1 time a day 12th-16th week 3 hours, 1 time a day

Other:
• Control group
According to the PERFECT score, a daily home guideline for the performance of PFMT will be requested three times a day, two types of exercises (endurance and strength), and eight repetitions of each.

Locations

Country	Name	City	State
Spain	RAPbarcelona SL	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
RAPbarcelona

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Oblasser C, Christie J, McCourt C. Vaginal cones or balls to improve pelvic floor muscle performance and urinary continence in women post partum: A quantitative systematic review. Midwifery. 2015 Nov;31(11):1017-25. doi: 10.1016/j.midw.2015.08.011. Epub 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of urinary incontinence using the ICIQ-SF questionnaire (International Consultation on Incontinence Questionnaire Short form) at Week 16.	The ICIQ-SF is a validated self-reported instrument assessing the urinary incontinence severity and It's quality of life. Possible scores range from 0 (no incontinence) to 21 (severe incontinence). Change=(Week 16 score - baseline score).	Time Frame: Baseline and Week 16