Pelvic Muscle Training and Electrostimulation to Treat Weak Pelvic Floor

NCT ID: NCT06419517

Last Updated: 2026-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-17
• Study Completion Date: 2025-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Supervised Pelvic Floor Muscle Training + EMG-triggered ES

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.

Group Type: EXPERIMENTAL

EMG-triggered ES

Intervention Type: 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.

Pelvic Floor Muscle Training

Intervention Type: 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).

Supervised PFMT + sham EMG-triggered ES)

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.

Group Type: ACTIVE_COMPARATOR

Pelvic Floor Muscle Training

Intervention Type: 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).

Interventions

EMG-triggered ES

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.

Intervention Type: DEVICE

Pelvic Floor Muscle Training

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).

Intervention Type: OTHER

Other Intervention Names

Pelvic Floor Muscle Training; EMG-triggered ES

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

BEACMED s.r.l.

UNKNOWN

Sponsor Role: collaborator

Azienda Unita Sanitaria Locale di Piacenza

OTHER

Sponsor Role: lead

Responsible Party

DR. GIANFRANCO LAMBERTI

Director, Rehabilitative Medicine Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gianfranco Lamberti, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda USL Piacenza

Locations

OSPEDALE FIORENZUOLA d'ARDA

Fiorenzuola d'Arda, PC, Italy

Countries

Italy

References

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.

Reference Type: RESULT

PMID: 30288727 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15014933 (View on PubMed)

Other Identifiers

23-0000035

Identifier Type: -

Identifier Source: org_study_id