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

NCT07733583 | Recruiting

• 1 other identifier: 2025-0492
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Endometriosis; Chronic Pelvic Pain

Keywords

Pelvic Floor Physical Therapy; Chronic Pelvic Pain; Endometriosis; Randomized Controlled Trial; Physical Exercise; Quality of Life; Dyspareunia; Dysmenorrhea

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (20)

• Neuropathic Pain Symptoms (painDETECT)

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

• Central Sensitization Symptoms (CSI-A)

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

• Female Sexual Function (FSFI)

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

• Endometriosis-Specific Quality of Life (EHP-30)

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

• General Quality of Life (WHOQOL-BREF)

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

Study Arms (2)

Pelvic Floor Physical Therapy Plus Physical Exercise

EXPERIMENTAL

Participants assigned to this arm will receive specialized pelvic floor physical therapy combined with a structured progressive physical exercise program for 12 weeks.

Behavioral: Pelvic Floor Physical Therapy; Behavioral: Physical Exercise

Placebo Pelvic Floor Physical Therapy Plus Physical Exercise

PLACEBO COMPARATOR

Participants 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.

Behavioral: Placebo Pelvic Floor Physical Therapy; Behavioral: Physical Exercise

Interventions

Pelvic Floor Physical Therapy BEHAVIORAL

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.

Pelvic Floor Physical Therapy Plus Physical Exercise

Placebo Pelvic Floor Physical Therapy BEHAVIORAL

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.

Placebo Pelvic Floor Physical Therapy Plus Physical Exercise

Physical Exercise BEHAVIORAL

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

Pelvic Floor Physical Therapy Plus Physical Exercise; Placebo Pelvic Floor Physical Therapy Plus Physical Exercise

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Federal University of Rio Grande do Sul: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

MeSH Terms

Conditions

Endometriosis; Motor Activity; Dyspareunia; Dysmenorrhea

Interventions

Exercise

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Behavior; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• João da Cunha Filho, PhD

  Hospital de Clínicas de Porto Alegre

  STUDY DIRECTOR

Central Study Contacts

Priscila Peixoto da Fonseca, PT, MSc Candidate

CONTACT

+5551984629624; ppfonseca@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to treatment allocation. The physical therapist delivering the interventions will not be blinded because of the nature of the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the placebo control group.

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 29, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): September 14, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

BR (1)