Effects of Pilates With and Without Voluntary Pelvic Floor Muscle Contraction Compared to Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence

NCT07421531 | Completed DMC

• 1 other identifier: 88644825.5.0000.5152
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This assessor-blinded randomized controlled trial aims to compare the effectiveness of three exercise programs for the treatment of stress urinary incontinence (SUI) in women: (1) Pilates without voluntary pelvic floor muscle contraction, (2) Pilates combined with voluntary pelvic floor muscle contraction, and (3) isolated pelvic floor muscle training (PFMT). Seventy-eight women aged over 18 years with self-reported SUI are randomly allocated into three parallel groups. Interventions last 6 weeks, with two sessions per week (12 sessions). The primary outcome is the change in the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) score from baseline to post-intervention. Secondary outcomes include urinary frequency and leakage episodes (72-hour bladder diary), pelvic floor muscle strength (Modified Oxford Scale), endurance, rapid contractions, and vaginal squeeze pressure measured by perineal manometry (Peritron). The hypothesis is that Pilates combined with voluntary pelvic floor muscle contraction will be superior to Pilates alone and comparable or superior to isolated PFMT.

Conditions

Stress Urinary Incontinence (SUI)

Outcome Measures

Primary Outcomes (1)

• Change in International Consultation on Incontinence (ICIQ-SF) total score

  Difference in total score from baseline to post-intervention. Higher scores indicate worse urinary incontinence impact.

  Baseline and 6 weeks

Secondary Outcomes (2)

• Change in urinary leakage episodes (72-hour bladder diary)

  Baseline and 6 weeks

• Change in Pelvic Floor Muscle Strength (Modified Oxford Scale, 0-5)

  baseline and 6 weeks

Study Arms (3)

Arm 1 - Pelvic floor muscle training

ACTIVE COMPARATOR

Intervention: Behavioral: Pelvic Floor Muscle Training Participants perform isolated pelvic floor muscle exercises in supine, sitting, and standing positions, including sustained and rapid contractions, twice weekly for 12 session. Stretching and mobility exercises are performed during rest intervals.

Other: Pelvic Floor Muscle Training

Arm 2 - Pilates group

EXPERIMENTAL

Intervention: Other: Pilates Exercise Program Participants perform mat and equipment-based Pilates exercises (Reformer, Chair, Cadillac) for 6 weeks, twice weekly - 12 session. Exercises are performed in three progressive phases (8-10-12 repetitions, 3 sets). Abdominal contraction is requested during expiration to activate the "powerhouse," without voluntary pelvic floor muscle contraction instruction.

Other: Pilates Exercise Program

Arm 3 - Pilates + pelvic floor contraction

EXPERIMENTAL

Intervention: Other: Pilates With Voluntary Pelvic Floor Muscle Contraction Same protocol as the Pilates group; however, participants are instructed to perform simultaneous voluntary pelvic floor muscle contraction during each expiratory phase.

Other: Pilates With Voluntary Pelvic Floor Muscle Contraction

Interventions

Pelvic Floor Muscle Training OTHER

Supervised isolated pelvic floor muscle exercises performed in supine, sitting, and standing positions, including sustained and rapid contractions, twice weekly for 12 sessions.

Arm 1 - Pelvic floor muscle training

Pilates Exercise Program OTHER

12-session supervised Pilates program including mat and apparatus exercises (Reformer, Chair, Cadillac), performed twice weekly. Abdominal activation during expiration is required, without voluntary pelvic floor muscle contraction instruction.

Arm 2 - Pilates group

Pilates With Voluntary Pelvic Floor Muscle Contraction OTHER

Same 12-session supervised Pilates protocol, with simultaneous voluntary pelvic floor muscle contraction during each expiratory phase.

Arm 3 - Pilates + pelvic floor contraction

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women ≥18 years Self-reported stress urinary incontinence Positive response to stress-related leakage question
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women ≥18 years
• Self-reported stress urinary incontinence
• Positive response to stress-related leakage question

You may not qualify if:

• Inability to read/respond to questionnaires
• Urinary tract infection within last 2 weeks
• Current smoking
• Previous pelvic surgery (except cesarean section)
• Previous pelvic radiotherapy
• Neurological disease
• Pelvic floor muscle strength grade 0-1 (Modified Oxford Scale)
• Pregnancy or \<3 months postpartum

Sponsors & Collaborators

• Federal University of Uberlandia: lead

Study Sites (1)

Federal University of Uberlandia

Uberlândia, Minas Gerais, 30400-678, Brazil

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PT, PhD

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: March 7, 2022
• Primary Completion: November 29, 2025
• Study Completion: November 29, 2025
• Last Updated: February 19, 2026

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication and ending 5 years after publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

BR (1)