## Protocol Section
### Identification Module
**NCT ID:** NCT06419517

**Brief Title:** Pelvic Muscle Training and Electrostimulation to Treat Weak Pelvic Floor

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

#### Organization Study ID Info
**ID:** 23-0000035
#### Organization
**Class:** OTHER
**Full Name:** Azienda Unità Sanitaria Locale di Piacenza
### Status Module
#### Completion Date
**Date:** 2026-06-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-05-11

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-17

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** BEACMED s.r.l.

#### Lead Sponsor

**Class:** OTHER

**Name:** Azienda Unità Sanitaria Locale di Piacenza

#### Responsible Party

**Investigator Affiliation:** Azienda Unità Sanitaria Locale di Piacenza

**Investigator Full Name:** DR. GIANFRANCO LAMBERTI

**Investigator Title:** Director, Rehabilitative Medicine Department

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Pelvic Floor Muscle Weakness

- Incontinence Stress

- Electricity; Effects

- Muscle Weakness Condition

**Keywords:**

- Pelvic Floor Muscle Weakness

- Electrical Stimulation

- Pelvic Floor Muscle Training

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Multicentric Prospective Clinical Trial with two parallel arms

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** 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)

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Device: EMG-triggered ES

- Other: Pelvic Floor Muscle Training

**Label:** Supervised Pelvic Floor Muscle Training + EMG-triggered ES

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Other: Pelvic Floor Muscle Training

**Label:** Supervised PFMT + sham EMG-triggered ES)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Supervised Pelvic Floor Muscle Training + EMG-triggered ES

**Description:** 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.

**Name:** EMG-triggered ES

**Other Names:**

- Pelvic Floor Muscle Training

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Supervised PFMT + sham EMG-triggered ES)

- Supervised Pelvic Floor Muscle Training + EMG-triggered ES

**Description:** 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).

**Name:** Pelvic Floor Muscle Training

**Other Names:**

- EMG-triggered ES

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** PFM strength by digital palpation done in the lithotomy position

**Measure:** Pelvic Floor Muscles (PFM) Strength

**Time Frame:** Baseline, four weeks, 6 and 12 months follow-up

#### Secondary Outcomes

**Description:** The change incontinence frequency (n.of episodes) deducted by frequency/volume chart

**Measure:** Frequency/volume chart

**Time Frame:** Baseline, four weeks, 6 and 12 months follow-up

**Description:** 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)

**Measure:** International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF)

**Time Frame:** Baseline, four weeks, 6 and 12 months follow-up

### Eligibility Module

**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.

**Gender Based:** True

**Gender Description:** Person's sense of self

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** g.lamberti2@ausl.pc.it

**Name:** Gianfranco Lamberti, MD

**Phone:** +390523404657

**Role:** CONTACT

**Contact 2:**

**Email:** g.ciardi@ausl.pc.it

**Name:** Gianluca Ciardi, MD

**Phone:** +390523404657

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Fiorenzuola d'Arda

**Contacts:**

***Contact 1:***

- **Email:** g.lamberti2@ausl.pc.it

- **Name:** Gianfranco Lamberti, MD

- **Phone:** +390523404657

- **Role:** CONTACT

**Country:** Italy

**Facility:** OSPEDALE FIORENZUOLA d'ARDA

**State:** PC

**Status:** RECRUITING

**Zip:** 29017

#### Overall Officials

**Official 1:**

**Affiliation:** Azienda USL Piacenza

**Name:** Gianfranco Lamberti, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** Individual participant data after deidentification

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 30288727

**Citation:** 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

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009135

- Term: Muscular Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000020879

- Term: Neuromuscular Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000010335

- Term: Pathologic Processes

- ID: D000014549

- Term: Urinary Incontinence

- ID: D000014555

- Term: Urination Disorders

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000059411

- Term: Lower Urinary Tract Symptoms

- ID: D000020924

- Term: Urological Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M20944

- Name: Muscle Weakness

- Relevance: HIGH

- As Found: Muscle Weakness

- ID: M13204

- Name: Paresis

- Relevance: HIGH

- As Found: Muscle Weakness

- ID: M4554

- Name: Asthenia

- Relevance: HIGH

- As Found: Weakness

- ID: M17300

- Name: Urinary Incontinence, Stress

- Relevance: HIGH

- As Found: Incontinence Stress

- ID: M17299

- Name: Urinary Incontinence

- Relevance: LOW

- As Found: Unknown

- ID: M7936

- Name: Enuresis

- Relevance: LOW

- As Found: Unknown

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22619

- Name: Neuromuscular Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M17305

- Name: Urination Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M29464

- Name: Lower Urinary Tract Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M22659

- Name: Urological Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000018908

- Term: Muscle Weakness

- ID: D000010291

- Term: Paresis

- ID: D000014550

- Term: Urinary Incontinence, Stress

- ID: D000001247

- Term: Asthenia

### Misc Info Module

- Version Holder: 2024-05-31
