Pelvic Muscle Training and Electrostimulation to Treat Weak Pelvic Floor

Pelvic Floor Muscle Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06419517
• Other study ID #: 23-0000035
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2024
• Est. completion date: June 15, 2026

Study information

• Verified date: May 2024
• Source: Azienda Unità Sanitaria Locale di Piacenza
• Contact: Gianfranco Lamberti, MD
• Phone: +390523404657
• Email: g.lamberti2[@]ausl.pc.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 15, 2026
• Est. primary completion date: May 11, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthenia
• Electricity; Effects
• Incontinence Stress
• Muscle Weakness
• Muscle Weakness Condition
• Paresis
• Pelvic Floor Muscle Weakness
• Urinary Incontinence, Stress

Intervention

Device:
• 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.

Other:
• 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).

Locations

Country	Name	City	State
Italy	OSPEDALE FIORENZUOLA d'ARDA	Fiorenzuola d'Arda	PC

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Unità Sanitaria Locale di Piacenza	BEACMED s.r.l.

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency/volume chart	The change incontinence frequency (n.of episodes) deducted by frequency/volume chart	Baseline, four weeks, 6 and 12 months follow-up
Secondary	International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF)	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)	Baseline, four weeks, 6 and 12 months follow-up