Pelvic Muscle Training and Electrostimulation to Treat Weak Pelvic Floor

Launched by AZIENDA UNITA SANITARIA LOCALE DI PIACENZA · May 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help women with weak pelvic floor muscles, which can lead to stress urinary incontinence (leakage when sneezing, coughing, or exercising). The researchers want to find out if adding a special type of electrical stimulation, activated by muscle signals, to standard pelvic floor muscle training can improve muscle strength and reduce leakage.

To be eligible for this study, participants need to be women aged 18 to 50 who have experienced leakage episodes more than once a week and are between six to eighteen months after giving birth. They should be willing to commit to 12 weeks of pelvic floor exercises and participate in physical evaluations. During the study, participants will engage in muscle training and receive the electrical stimulation, and they will keep track of their progress. It’s important to note that certain medical conditions and recent surgeries may prevent some women from participating. This trial aims to provide new insights into effective treatments for pelvic floor weakness and incontinence.

Gender

FEMALE

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.

Trial Officials