NCT05732844

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

January 29, 2023

Last Update Submit

February 8, 2023

Conditions

Urinary IncontinenceStress Urinary IncontinenceSexual Dysfunction

Keywords

vaginal spheresphysiotherapypelvic floor muscle trainning

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Intervention group with Enna pelvic ball

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Other: Control group

Interventions

Intervention group with Enna pelvic ballDEVICE

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 group with Enna pelvic ball
Control groupOTHER

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.

Control group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RAPbarcelona SL

Barcelona, 08037, Spain

Location

Related 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 2015 Sep 9.

    PMID: 26428191RESULT

MeSH Terms

Conditions

Urinary IncontinenceUrinary Incontinence, StressSexual Dysfunction, Physiological

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 29, 2023

First Posted

February 17, 2023

Study Start

October 5, 2022

Primary Completion

January 27, 2023

Study Completion

January 27, 2023

Last Updated

February 17, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)