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

NCT05732844 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-02-17

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • RAPbarcelona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-05
Primary Completion
2023-01-27
Completion
2023-01-27

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05732844 on ClinicalTrials.gov