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OpenTrials
Completed

NCT Number: NCT05732844

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

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Sexual Dysfunction Sexual Dysfunction, Physiological Signs and Symptoms Stress Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

RAPbarcelona SL

Barcelona, 08037, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention group with Enna pelvic ball

Device

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

Control Group

Other

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 outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

RAPbarcelona

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 17, 2023
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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