Pelvic Floor Muscle WeaknessNCT06419517
Pelvic Muscle Training and Electrostimulation to Treat Weak Pelvic Floor
A study testing EMG-triggered ES and Pelvic Floor Muscle Training in people with Pelvic Floor Muscle Weakness and Incontinence Stress, run by Azienda Unita Sanitaria Locale di Piacenza at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pelvic Floor Muscle Weakness, Incontinence Stress, Electricity; Effects
- What is being tested?
- EMG-triggered ES and Pelvic Floor Muscle Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 17 May 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • 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
Who cannot join
- • 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
Show all 17Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of PFMT and sEMG-triggered Electrostimulation in Treating the Very Weak Pelvic Floor: a Randomized Clinical Trial
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)
Read the 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
- Being tested
- EMG-triggered ES, Pelvic Floor Muscle Training
- Keywords
- Pelvic Floor Muscle Weakness, Electrical Stimulation, Pelvic Floor Muscle Training
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMG-triggered ESDevice
Also called Pelvic Floor Muscle Training
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 TrainingOther
Also called EMG-triggered ES
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Pelvic Floor Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Floor Muscles (PFM) Strength
PFM strength by digital palpation done in the lithotomy position
Measured: Baseline, four weeks, 6 and 12 months follow-up
Secondary outcomes (2)
Frequency/volume chart
The change incontinence frequency (n.of episodes) deducted by frequency/volume chart
Measured: Baseline, four weeks, 6 and 12 months follow-up
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)
Measured: Baseline, four weeks, 6 and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start17 May 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor Muscle WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentric Prospective Clinical Trial with two parallel arms
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Unita Sanitaria Locale di Piacenza
- Sponsor type
- University, hospital or other
- Collaborators
- BEACMED s.r.l.
- Responsible party
- Principal investigator, DR. GIANFRANCO LAMBERTI, Azienda Unita Sanitaria Locale di Piacenza
- Investigators
- Gianfranco Lamberti, MD, Principal investigator, Azienda USL Piacenza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419517
- Sponsor's protocol ID
- 23-0000035
- Status last verified
- Feb 2026
- First submitted
- 14 May 2024
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data after deidentification
Publications
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.
PubMed 30288727Bo 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.
PubMed 15014933
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of PFMT and sEMG-triggered Electrostimulation in Treating the Very Weak Pelvic Floor: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06419517
- Acronym / sponsor ID
- 23-0000035
- Conditions
- Pelvic Floor Muscle Weakness, Incontinence Stress, Electricity; Effects, Muscle Weakness Condition
- Keywords
- Pelvic Floor Muscle Weakness, Electrical Stimulation, Pelvic Floor Muscle Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Azienda Unita Sanitaria Locale di PiacenzaUniversity, hospital or other
- Collaborators
- BEACMED s.r.l.
- Study start
- 17 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Multicentric Prospective Clinical Trial with two parallel arms
| Arm | Type | Receives |
|---|---|---|
| Supervised Pelvic Floor Muscle Training + EMG-triggered ES | Experimental | Device: EMG-triggered ES, Other: Pelvic Floor Muscle TrainingGroup 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. |
| Supervised PFMT + sham EMG-triggered ES) | Active comparator | Other: Pelvic Floor Muscle TrainingGroup 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • 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.
Key exclusion criteria (17 listed)
- • pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMG-triggered ESAlso: Pelvic Floor Muscle TrainingThe 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. | Device | Supervised Pelvic Floor Muscle Training + EMG-triggered ES |
| Pelvic Floor Muscle TrainingAlso: EMG-triggered ESStandardization 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). | Other | Supervised PFMT + sham EMG-triggered ES), Supervised Pelvic Floor Muscle Training + EMG-triggered ES |
Primary outcome
Pelvic Floor Muscles (PFM) Strength
Time frame: Baseline, four weeks, 6 and 12 months follow-up
PFM strength by digital palpation done in the lithotomy position
2 secondary outcomes
Frequency/volume chart
Time frame: Baseline, four weeks, 6 and 12 months follow-up
International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF)
Time frame: Baseline, four weeks, 6 and 12 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Results publication: PubMed 30288727Dumoulin 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.
- Results publication: PubMed 15014933Bo 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.
- Individual participant dataSharing planned: No. Individual participant data after deidentification
Related trials for Pelvic Floor Muscle Weakness
Recruiting
Ultrasound and Electromyography Biofeedback for Pelvic Floor Muscle Training
Pelvic Floor Dysfunction, Pelvic Floor Muscle Weakness
Active, not recruiting
Effects of Kegel Ball and Pelvic Floor Exercises on Sexual Function, Unrınary Incontinence and Quality of Life in Women
Urinary Dysfunction, Vaginal Prolapse
Enrolling by invitationObservational study
Digital Care Programs for Female Pelvic Health
Pelvic Floor Disorders, Pelvic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianfranco Lamberti, MD principal investigator
Azienda USL Piacenza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMG-triggered ES and Pelvic Floor Muscle Training in people with Pelvic Floor Muscle Weakness and Incontinence Stress, run by Azienda Unita Sanitaria Locale di Piacenza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Floor Muscles (PFM) Strength (time frame: Baseline, four weeks, 6 and 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06419517, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.