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Completed

NCT Number: NCT06419517

Pelvic Muscle Training and Electrostimulation to Treat Weak Pelvic Floor

This research will determine 1) whether the very weak pelvic floor can be improved with surface electromyography (s-EMG)-triggered electrostimulation added to pelvic floor muscle training and 2) whether sEMG-triggered electrostimulation added to pelvic floor muscle training can reduce leakage in Stress Urinary Incontinence (SUI)

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Key information

About this study

Among women with pelvic floor dysfunction, it has long been known that PFM training is the first-line therapy for stress incontinence. One of the difficulties that clinicians often find upon examination is that many women present a very weak pelvic floor and are unable to contract their PFM. There is overwhelming evidence to show that conservative treatment in the form of pelvic muscle exercises (and to a lesser degree, electrotherapy, and vaginal weight therapy) is effective in the treatment of stress urinary incontinence. To date, there is some evidence to support the use of electrical stimulation for stress urinary incontinence in women, but we are still very uncertain about the full potential of this treatment because of the low quality of the existing evidence.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • • Adult women (18 years old - 50 years old), with a Modified Oxford Score, determined by digital palpation, of 0 - 1, complaining leakage episode occurring more than once a week.
  • Between six and eighteen months after childbirth
  • Willing and able to be compliant with pelvic floor muscle exercise intervention (standard of care) for 12 weeks and to log compliance
  • Willing and able to undergo an extensive physical function evaluation

Exclusion criteria

  • • pregnancy
  • severe neurological disease (Multiple Sclerosis, Parkinson's disease, spinal cord injury, major stroke or neuromuscular junction diseases)
  • previous operation for cancer or radiotherapy in the lower abdomen
  • Prior surgical intervention for urinary incontinence within the past 12 months
  • Hysterectomy within 12 months
  • voiding dysfunction
  • pelvic pain
  • severe prolapse (≥ grade 3)
  • recurrent urinary tract infection
  • pelvic or disseminated malignancies
  • women who were virgo intacta
  • women who declined vaginal examinations for any reasons
  • before four months of pregnancy
  • Having significant cognitive impairment or dementia
  • Unsafe to exercise (severe cardiopulmonary disease)
  • Unable/unwilling to provide informed consent
  • Patient has on physical examination, neurological and/or vaginal examination results which, in the opinion of the investigator, should exclude the subject.

Treatment and study plan

EMG-triggered ES

Device

The ES treatment protocol consisted of daily endovaginal electrostimulation sessions for four weeks. We used a portable unit EVOSTIM ®, which allowed us to use different frequencies and length of impulse and a probe Perisphera ® The average current intensity was adjusted according to the sensation of discomfort in each patient.

Other names: Pelvic Floor Muscle Training

Pelvic Floor Muscle training

Other

Standardization of the supervised PFMT To achieve standardization of supervised PFMT treatments, a written protocol for the physiotherapeutic examinations and PFMT program will be provided to the physiotherapists (or nurse or midwife) delivering the treatments (See Additional file).

Other names: EMG-triggered ES

Primary outcomes

  1. Pelvic Floor Muscles (PFM) Strength

    Time frame: Baseline, four weeks, 6 and 12 months follow-up

    PFM strength by digital palpation done in the lithotomy position

Secondary outcomes

  1. Frequency/volume chart

    Time frame: Baseline, four weeks, 6 and 12 months follow-up

    The change incontinence frequency (n.of episodes) deducted by frequency/volume chart

  2. International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF)

    Time frame: Baseline, four weeks, 6 and 12 months follow-up

    Change of "International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF" scores, which varie from 0 (no impact of incontinence) to 19 (worst impact of incontinence in everyday life)

Sponsors and collaborators

Lead sponsor

Azienda Unita Sanitaria Locale di Piacenza

Other

Collaborators

  • BEACMED s.r.l.

Registry information

Official study title

Efficacy of PFMT and sEMG-triggered Electrostimulation in Treating the Very Weak Pelvic Floor: a Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 17, 2024
Registry last updated
Feb 3, 2026

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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