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

Sponsor

RAPbarcelona (Other)

Overall Status

Completed

CT.gov ID

NCT05732844

Collaborator

(none)

Enrollment

Location

Arms

3.7

Actual Duration (Months)

17.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence Stress Urinary Incontinence Sexual Dysfunction	Device: Intervention group with Enna pelvic ball Other: Control group	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 5, 2022

Actual Primary Completion Date :

Jan 27, 2023

Actual Study Completion Date :

Jan 27, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group with Enna pelvic ball This group will receive instructions on how to carry out PFMT daily at home, and indications for the placement of Enna pelvic ball vaginal spheres daily.	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
Active Comparator: Control group This group will receive instructions on how to carry out PFMT daily at home.	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.

Arm

Intervention/Treatment

Experimental: Intervention group with Enna pelvic ball

This group will receive instructions on how to carry out PFMT daily at home, and indications for the placement of Enna pelvic ball vaginal spheres daily.

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

Active Comparator: Control group

This group will receive instructions on how to carry out PFMT daily at home.

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.

Outcome Measures

Primary Outcome Measures

Severity of urinary incontinence using the ICIQ-SF questionnaire (International Consultation on Incontinence Questionnaire Short form) at Week 16. [Time Frame: Baseline and 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	RAPbarcelona SL	Barcelona		Spain	08037

Sponsors and Collaborators

RAPbarcelona

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Inés Ramírez-García, Director, RAPbarcelona

ClinicalTrials.gov Identifier:

NCT05732844

Other Study ID Numbers:

LAIA_bolas

First Posted:

Feb 17, 2023

Last Update Posted:

Feb 17, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Inés Ramírez-García, Director, RAPbarcelona

vaginal spheres

physiotherapy

pelvic floor muscle trainning

Additional relevant MeSH terms:

Urinary Incontinence

Enuresis

Urinary Incontinence, Stress

Study Results

No Results Posted as of Feb 17, 2023