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

February 8, 2023 updated by: Inés Ramírez-García, RAPbarcelona

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08037
        • RAPbarcelona SL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RAPbarcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2022

Primary Completion (Actual)

January 27, 2023

Study Completion (Actual)

January 27, 2023

Study Registration Dates

First Submitted

January 29, 2023

First Submitted That Met QC Criteria

February 8, 2023

First Posted (Actual)

February 17, 2023

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAIA_bolas

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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