Pelvic Muscle Training and Electrostimulation to Treat Weak Pelvic Floor

NCT06419517 | Completed

• 1 other identifier: 23-0000035
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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)

Conditions

Muscle Weakness Condition; Pelvic Floor Muscle Weakness; Incontinence Stress; Electricity; Effects

Keywords

Pelvic Floor Muscle Weakness; Electrical Stimulation; Pelvic Floor Muscle Training

Outcome Measures

Primary Outcomes (1)

• Pelvic Floor Muscles (PFM) Strength

  PFM strength by digital palpation done in the lithotomy position

  Baseline, four weeks, 6 and 12 months follow-up

Secondary Outcomes (2)

• Frequency/volume chart

  Baseline, four weeks, 6 and 12 months follow-up

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

  Baseline, four weeks, 6 and 12 months follow-up

Study Arms (2)

Supervised Pelvic Floor Muscle Training + EMG-triggered ES

EXPERIMENTAL

Group A (supervised PFMT + EMG-triggered ES) Supervised Pelvic Floor Muscle Training Twenty sessions will be applied, 2 per week for ten weeks Stimulation parameters: Duration: 15 min Electrode placement: vaginal probe Frequency: 50 Hz. - Pulse width 250 microseconds Intensity: to motor response (activation of PFM) Number of sessions: 20 Ramp up/down: 1 sec.

Device: EMG-triggered ES; Other: Pelvic Floor Muscle Training

Supervised PFMT + sham EMG-triggered ES)

ACTIVE COMPARATOR

Group B: Supervised PFMT + sham EMG-triggered ES) Supervised Pelvic Floor Muscle Training Twenty sessions will be applied, 2 per week for ten weeks Stimulation parameters: Duration: 15 min Electrode placement: vaginal probe model xx Frequency: 2 Hz. - Pulse width 10 microseconds Intensity: to sensory response Number of sessions: 20 Ramp up/down: 1 sec.

Other: Pelvic Floor Muscle Training

Interventions

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.

Also known as: Pelvic Floor Muscle Training

Supervised Pelvic Floor Muscle Training + EMG-triggered ES

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).

Also known as: EMG-triggered ES

Supervised PFMT + sham EMG-triggered ES); Supervised Pelvic Floor Muscle Training + EMG-triggered ES

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Person's sense of self
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• BEACMED s.r.l.: collaborator
• Azienda Unita Sanitaria Locale di Piacenza: lead

Study Sites (1)

OSPEDALE FIORENZUOLA d'ARDA

Fiorenzuola d'Arda, PC, 29017, Italy

Location

Related Publications (2)

• 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.

  PMID: 30288727 RESULT

• 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.

  PMID: 15014933 RESULT

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gianfranco Lamberti, MD

  Azienda USL Piacenza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (participants, principal investigator). To improve the effect of blindness, participants were informed that the trial intended to compare the effects of two Electrical Stimulation (ES) methods for Stress Urinary Incontinence (SUI)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Rehabilitative Medicine Department

Model Details: Multicentric Prospective Clinical Trial with two parallel arms

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 17, 2024
• Study Start: May 17, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)