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EndometriosisNCT07733583

Pelvic Floor Physical Therapy and Exercise for Women With Endometriosis and Chronic Pelvic Pain

A study testing Pelvic Floor Physical Therapy and Physical Exercise in people with Endometriosis and Chronic Pelvic Pain, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Endometriosis is a chronic gynecological condition that can cause persistent pelvic pain, painful menstruation, painful sexual intercourse, and reduced quality of life. This study will evaluate whether specialized pelvic floor physical therapy combined with a structured physical exercise program is more effective than… Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Endometriosis, Chronic Pelvic Pain
What is being tested?
Pelvic Floor Physical Therapy and Physical Exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
1 siteBrazil
Study dates
5 Mar 2026to 30 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Female, aged 18 to 45 years.
  • Diagnosis of endometriosis confirmed by surgery and/or imaging examinations.
  • Chronic pelvic pain for at least 6 months.
  • Visual Analog Scale (VAS) score ≥4 for chronic pelvic pain.
  • Willingness and ability to provide written informed consent and comply with all study procedures.

Who cannot join

  • Current pregnancy or planned pregnancy during the study period.
  • Pelvic surgery within the previous 3 months.
  • Neuromodulation treatment within the previous 3 months.
  • Medical or musculoskeletal conditions that contraindicate participation in pelvic floor physical therapy or the exercise program.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Priscila Peixoto da Fonseca, PT, MSc Candidate contact

+5551984629624

ppfonseca@hcpa.edu.br

Brazil1 site, 1 recruiting
  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul

    Priscila Peixoto da Fonseca, PT, MSc Candidate, +5551984629624, ppfonseca@hcpa.edu.br

    Recruiting

Other trials in Brazil

About this study

Official title: Pelvic Floor Physical Therapy and Physical Exercise Versus Placebo for the Treatment of Endometriosis With Chronic Pelvic Pain: A Randomized Controlled Trial

Endometriosis is a chronic gynecological condition that can cause persistent pelvic pain, painful menstruation, painful sexual intercourse, and reduced quality of life. This study will evaluate whether specialized pelvic floor physical therapy combined with a structured physical exercise program is more effective than a placebo intervention combined with the same exercise program in reducing chronic pelvic pain in women with endometriosis. Participants will be randomly assigned to one of the two groups and followed for 12 weeks.

Read the detailed description

Endometriosis is a chronic estrogen-dependent inflammatory disease frequently associated with chronic pelvic pain, dysmenorrhea, dyspareunia, impaired quality of life, sexual dysfunction, and central pain sensitization. Although pelvic floor physical therapy and exercise have demonstrated potential benefits, high-quality randomized placebo-controlled trials evaluating their combined effects remain limited.

This study is a prospective, double-blind, randomized, placebo-controlled clinical trial designed to evaluate the effectiveness of specialized pelvic floor physical therapy combined with a structured physical exercise program compared with a placebo intervention combined with the same exercise program in women with confirmed endometriosis and chronic pelvic pain.

Sixty-four participants will be randomly allocated (1:1) to either the intervention group or the placebo group. Both groups will participate in the same 12-week progressive exercise program. The intervention group will receive specialized pelvic floor physical therapy, whereas the control group will receive a placebo pelvic floor physical therapy protocol designed to maintain participant blinding without providing specific therapeutic effects.

Participants will be evaluated at baseline (week 0), after 8 weeks, and at the end of the 12-week intervention. The primary outcome is the intensity of chronic pelvic pain. Secondary outcomes include neuropathic pain symptoms, central sensitization, quality of life, sexual function, depressive symptoms, pelvic floor muscle function, treatment adherence, and participant satisfaction.

Being tested
Pelvic Floor Physical Therapy, Placebo Pelvic Floor Physical Therapy, Physical Exercise
Keywords
Pelvic Floor Physical Therapy, Chronic Pelvic Pain, Endometriosis, Randomized Controlled Trial, Physical Exercise, Quality of Life, Dyspareunia, Dysmenorrhea
Medical subject headings
Endometriosis, Motor Activity, Dyspareunia, Dysmenorrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pelvic Floor Physical TherapyBehavioural

    Specialized pelvic floor physical therapy administered over 12 weeks, including individualized assessment and evidence-based treatment targeting pelvic floor dysfunction associated with endometriosis-related chronic pelvic pain. Treatment may include manual therapy, pelvic floor muscle training, therapeutic exercises, education, and other physiotherapy techniques according to participants' clinical findings.

  • Placebo Pelvic Floor Physical TherapyBehavioural

    Placebo pelvic floor physical therapy administered over 12 weeks using procedures designed to maintain participant blinding without providing specific therapeutic effects. Participants will receive the same number and duration of sessions as the experimental group.

  • Physical ExerciseBehavioural

    A structured progressive physical exercise program administered over 12 weeks, consisting of six progressive phases and provided equally to participants in both study arms.

Study groups in NCT07733583
Study groupRoleWhat they receive
Pelvic Floor Physical Therapy Plus Physical ExerciseExperimentalParticipants assigned to this arm will receive specialized pelvic floor physical therapy combined with a structured progressive physical exercise program for 12 weeks.
Receives: Behavioral: Pelvic Floor Physical Therapy; Behavioral: Physical Exercise
Placebo Pelvic Floor Physical Therapy Plus Physical ExercisePlacebo comparatorParticipants assigned to this arm will receive a placebo pelvic floor physical therapy intervention combined with the same structured progressive physical exercise program for 12 weeks.
Receives: Behavioral: Placebo Pelvic Floor Physical Therapy; Behavioral: Physical Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Chronic Pelvic Pain Intensity

    The primary outcome is the change in pain intensity measured using the Visual Analog Scale (VAS), a 0 to 10 scale in which 0 indicates no pain and 10 indicates the worst pain imaginable, for chronic pelvic pain, dysmenorrhea, and dyspareunia, from baseline to Week 8 and Week 12.

    Measured: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).

Secondary outcomes (20)
  1. Neuropathic Pain Symptoms (painDETECT)

    Neuropathic pain symptoms will be assessed using the painDETECT questionnaire. The outcome is the change in the total painDETECT score from baseline to after 8 treatment sessions and after completion of the 12-session intervention.

    Measured: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).

  2. Central Sensitization Symptoms (CSI-A)

    Central sensitization symptoms will be assessed using the Central Sensitization Inventory (CSI-A). The outcome is the change in the total CSI-A score from baseline to after 8 treatment sessions and after completion of the 12-session intervention.

    Measured: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).

  3. Female Sexual Function (FSFI)

    Female sexual function will be assessed using the Female Sexual Function Index (FSFI). The outcome is the change in the total FSFI score from Baseline to after 8 treatment sessions and after completion of the 12-session intervention. Scores range from 2 to 36 points, with higher scores indicating better female sexual function.

    Measured: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).

  4. Endometriosis-Specific Quality of Life (EHP-30)

    Health-related quality of life will be assessed using the Endometriosis Health Profile-30 (EHP-30). The EHP-30 is a 30-item questionnaire assessing five core domains: pain, control and powerlessness, emotional well-being, social support, and self-image. Scores for each domain are transformed to a standardized 0-100 scale, with higher scores indicating worse health-related quality of life.

    Measured: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).

  5. General Quality of Life (WHOQOL-BREF)

    Health-related quality of life will be assessed using the World Health Organization Quality of Life Instrument, Brief Version (WHOQOL-BREF), a 26-item questionnaire that assesses four domains: physical health, psychological health, social relationships, and environment. The outcome is the change in domain scores from baseline to after 8 treatment sessions and after completion of the 12-session intervention.

    Measured: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).

  6. Depressive Symptoms (BDI)

    Depressive symptoms will be assessed using the Beck Depression Inventory (BDI). The outcome is the change in the total BDI score from baseline to after 8 treatment sessions and after completion of the 12-session intervention.

    Measured: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).

  7. Treatment Adherence

    Treatment adherence will be assessed throughout the intervention by recording attendance at supervised treatment sessions and adherence to the prescribed home exercise program using participant adherence records.

    Measured: Throughout the 12-session intervention (approximately 12 weeks).

  8. Participant Satisfaction

    Participant satisfaction will be assessed after completion of the 12-session intervention using a study-specific questionnaire composed of 13 items rated on a 5-point Likert scale (1 = Strongly disagree to 5 = Strongly agree). Individual item responses will be analyzed to evaluate participants' perceptions of the intervention.

    Measured: After completion of the 12-session intervention (approximately 12 weeks).

  9. Pelvic Floor Muscle Strength (Modified Oxford Scale)

    Pelvic floor muscle strength will be assessed using the Modified Oxford Scale during standardized digital vaginal examination. The outcome is the change in muscle strength score from baseline to after 8 treatment sessions and after completion of the 12-session intervention. Scores range from 0 to 5, with higher scores indicating greater pelvic floor muscle strength.

    Measured: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).

  10. Pelvic Floor Muscle Endurance

    Pelvic floor muscle endurance will be assessed as the maximum duration of a sustained voluntary pelvic floor muscle contraction during standardized digital vaginal examination. The outcome is the change in contraction duration from baseline to after 8 treatment sessions and after completion of the 12-session intervention. Endurance is recorded in seconds, with higher values indicating greater muscle endurance.

    Measured: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).

  11. Repetitions of Sustained Contractions

    Pelvic floor muscle repetitions will be assessed as the number of sustained voluntary contractions performed before fatigue during standardized digital vaginal examination. The outcome is the change in the number of repetitions from baseline to after 8 treatment sessions and after completion of the 12-session intervention. Higher values indicate greater muscular endurance.

    Measured: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).

  12. Fast Contractions

    Fast pelvic floor muscle contractions will be assessed as the maximum number of rapid voluntary contractions completed in sequence during standardized digital vaginal examination. The outcome is the change in the number of fast contractions from baseline to after 8 treatment sessions and after completion of the 12-session intervention. Higher values indicate better pelvic floor muscle performance.

    Measured: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).

  13. Resting Pelvic Floor Muscle Tone

    Resting pelvic floor muscle tone will be assessed during standardized digital vaginal examination. The outcome is the change in resting muscle tone classification from baseline to after 8 treatment sessions and after completion of the 12-session intervention. Muscle tone is classified as hypotonic, normal, or hypertonic.

    Measured: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).

  14. Pelvic Floor Muscle Relaxation

    Pelvic floor muscle relaxation will be assessed during standardized digital vaginal examination following maximal voluntary contraction. The outcome is the change in relaxation ability from baseline to after 8 treatment sessions and after completion of the 12-session intervention. Relaxation is classified as complete, partial, or absent.

    Measured: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).

  15. Pain on Palpation

    Pain on pelvic floor muscle palpation will be assessed during standardized digital vaginal examination. The outcome is the change in the presence or absence of pain on palpation from baseline to after 8 treatment sessions and after completion of the 12-session intervention.

    Measured: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).

  16. Pain Intensity on Palpation (Visual Analog Scale - VAS)

    Pain intensity during pelvic floor muscle palpation will be assessed using the Visual Analog Scale (VAS). The outcome is the change in pain intensity score from baseline to after 8 treatment sessions and after completion of the 12-session intervention. Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.

    Measured: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).

  17. Pain Location on Palpation

    Pain location during standardized digital vaginal examination will be assessed by documenting the anatomical location(s) in which pain is reported during pelvic floor muscle palpation. The outcome is the change in pain location from baseline to after 8 treatment sessions and after completion of the 12-session intervention. Pain location is recorded as superficial, deep, rectal, or other.

    Measured: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).

  18. Pelvic Floor Muscle Elevation

    Pelvic floor muscle elevation during voluntary contraction will be assessed during standardized digital vaginal examination. The outcome is the change in the presence of cranial elevation of the pelvic floor muscles from baseline to after 8 treatment sessions and after completion of the 12-session intervention. Elevation is classified as present or absent.

    Measured: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).

  19. Co-contraction

    Co-contraction will be assessed during standardized digital vaginal examination by recording activation of synergistic muscles during voluntary pelvic floor muscle contraction. The outcome is the change in co-contraction pattern from baseline to after 8 treatment sessions and after completion of the 12-session intervention. Co-contraction is classified as none, transversus abdominis, gluteal muscles, adductor muscles, multiple muscles, or other.

    Measured: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).

  20. Timing

    Timing of pelvic floor muscle contraction will be assessed by evaluating the ability to voluntarily contract the pelvic floor muscles before or simultaneously with increased intra-abdominal pressure during standardized digital vaginal examination. The outcome is the change in timing classification from baseline to after 8 treatment sessions and after completion of the 12-session intervention. Timing is classified as present or absent.

    Measured: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2026
  2. Study start5 Mar 2026
  3. Primary completion14 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

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
Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the placebo control group.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07733583
Sponsor's protocol ID
2025-0492
Status last verified
Jul 2026
First submitted
20 Jul 2026
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Pelvic Floor Physical Therapy and Physical Exercise in people with Endometriosis and Chronic Pelvic Pain, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 29 Jul 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 Brazil. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Priscila Peixoto da Fonseca, PT, MSc Candidate (+5551984629624, ppfonseca@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chronic Pelvic Pain Intensity (time frame: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 29 Jul 2026.

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