Back to resultsEfficacy of the Use of Vaginal Balls for the Improvement of Urinary Incontinence and Sexual Function in Women.
Primary Purpose
Urinary Incontinence, Stress Urinary Incontinence, Sexual Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Intervention group with Enna pelvic ball
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring vaginal spheres, physiotherapy, pelvic floor muscle trainning
Eligibility Criteria
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
Sites / Locations
- RAPbarcelona SL
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group with Enna pelvic ball
Control group
Arm Description
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.
This group will receive instructions on how to carry out PFMT daily at home.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05732844
Brief Title
Efficacy of the Use of Vaginal Balls for the Improvement of Urinary Incontinence and Sexual Function in Women.
Official Title
Efficacy of the Use of Vaginal Balls for the Improvement of Urinary Incontinence and Sexual Function in Women. Randomized Control Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 5, 2022 (Actual)
Primary Completion Date
January 27, 2023 (Actual)
Study Completion Date
January 27, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RAPbarcelona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Stress Urinary Incontinence, Sexual Dysfunction
Keywords
vaginal spheres, physiotherapy, pelvic floor muscle trainning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group with Enna pelvic ball
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
This group will receive instructions on how to carry out PFMT daily at home.
Intervention Type
Device
Intervention Name(s)
Intervention group with Enna pelvic ball
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Severity of urinary incontinence using the ICIQ-SF questionnaire (International Consultation on Incontinence Questionnaire Short form) at Week 16.
Description
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
Time Frame: Baseline and Week 16
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
RAPbarcelona SL
City
Barcelona
ZIP/Postal Code
08037
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26428191
Citation
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 2015 Sep 9.
Results Reference
result
Learn more about this trial
Efficacy of the Use of Vaginal Balls for the Improvement of Urinary Incontinence and Sexual Function in Women.
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