Clinical trial NCT06419517: Pelvic Muscle Training and Electrostimulation to Treat Weak Pelvic Floor
Official title: Efficacy of PFMT and sEMG-triggered Electrostimulation in Treating the Very Weak Pelvic Floor: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pelvic Floor Muscle Weakness
Incontinence Stress
Electricity; Effects
Muscle Weakness Condition
Keywords: Pelvic Floor Muscle Weakness
Electrical Stimulation
Pelvic Floor Muscle Training
Lead sponsor: Azienda Unita Sanitaria Locale di Piacenza
Sponsor class: OTHER
Collaborators: name: BEACMED s.r.l.
First posted: 2024-05-17
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentric Prospective Clinical Trial with two parallel arms
Primary purpose: TREATMENT

Brief summary: 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)

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pelvic Floor Muscles (PFM) Strength
timeFrame: Baseline, four weeks, 6 and 12 months follow-up
Secondary outcomes:
measure: Frequency/volume chart
timeFrame: Baseline, four weeks, 6 and 12 months follow-up
measure: International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF)
timeFrame: Baseline, four weeks, 6 and 12 months follow-up
Other outcomes:
Locations:
city: Fiorenzuola d'Arda
country: Italy
facility: OSPEDALE FIORENZUOLA d'ARDA
state: PC
Study officials:
affiliation: Azienda USL Piacenza
name: Gianfranco Lamberti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dumoulin C, Cacciari LP, Hay-Smith EJC. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2018 Oct 4;10(10):CD005654. doi: 10.1002/14651858.CD005654.pub4.
citation: Bo K. Pelvic floor muscle training is effective in treatment of female stress urinary incontinence, but how does it work? Int Urogynecol J Pelvic Floor Dysfunct. 2004 Mar-Apr;15(2):76-84. doi: 10.1007/s00192-004-1125-0. Epub 2004 Jan 24.