Contin-RUN Study: Urinary Incontinence in Female Runners

NCT06595732 | Completed

• 1 other identifier: 75069623.3.0000.5152
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study comprises two phases, each with distinct objectives. The first phase aims to investigate the prevalence of urinary incontinence and other pelvic floor dysfunctions in Brazilian female runners through structured questionnaires. The second phase aims to evaluate and compare the effectiveness of three different exercise regimens for the treatment of urinary incontinence in female runners. The intervention groups include: a) pelvic floor muscle training combined with abdominal training, b) hypopressive abdominal exercises, and c) pelvic floor muscle training alone. The primary outcome measure is the severity of urinary incontinence, which will be assessed using the adapted 1-hour pad test and a 3-day bladder diary. Secondary outcomes include symptoms of pelvic floor dysfunction and pelvic floor muscle function. The intervention will last for 12 weeks, after which participants will be reassessed to determine which training regimen is most effective in treating urinary incontinence in female runners.

Conditions

Urinary Incontinence

Keywords

urinary incontinence; female runner; pelvic floor muscle training; Abdominal Hypopressive Technique

Outcome Measures

Primary Outcomes (1)

• Amount of urinary leakage during running

  The severity of urinary incontinence is the primary outcome of interest. The amount of urinary leakage will be assessed using a modified 1-hour pad test. The pad test will be performed on a treadmill. The participant will drink 500 ml of water in 15 minutes, wait another 15 minutes in rest, place a pre-weighed pad in her underwear, and then run continuously for 40 minutes on the treadmill at a comfortable speed of her choice. After the running period, the pad will be removed and weighed to determine the amount of urinary leakage in grams.

  From enrollment to the end of the treatment at 12 weeks

Secondary Outcomes (5)

• Frequency of urinary leakage

  From enrollment to the end of the treatment at 12 weeks

• Other pelvic floor dysfunction symptoms

  From enrollment to the end of the treatment at 12 weeks

• Pelvic floor muscle strength

  From enrollment to the end of the treatment at 12 weeks

• Pelvic floor manometry

  From enrollment to the end of the treatment at 12 weeks

• Impact of urinary incontinence in the quality of life

  From enrollment to the end of the treatment at 12 weeks

Study Arms (3)

1PFMT + Abd Group

EXPERIMENTAL

Participants in this group will perform pelvic floor muscle training in conjunction with abdominal muscle training. It is believed that abdominal contraction will lead to an increase in abdominal pressure, which will serve as additional load for pelvic floor muscle training.

Behavioral: Pelvic floor and abdominal training

AHG Group

EXPERIMENTAL

Participants in this group will perform Hypopressive Abdominal Gymnastics exercises (Caufriez, 1997). It is believed that these exercises reduce the pressure on the pelvic floor muscles and help tone this musculature without causing harm.

Behavioral: Abdominal Hypopressive Technique Exercises

PFMT Group

ACTIVE COMPARATOR

Participants of PFMT group will perform specific exercises for the pelvic floor muscles, with maximum contraction and without involvement of other muscle groups. This arm is considered the control group because it is the treatment that has been proven to effectively treat urinary incontinence, as demonstrated in over 50 clinical trials.

Other: Pelvic floor muscle training

Interventions

Pelvic floor and abdominal training BEHAVIORAL

Participants in this group will undergo 12 weeks of in-person training, with supervision by a specialist physical therapist, in groups of up to four women. The training will take place after an initial evaluation and will consist of 24 sessions, held twice a week. Exercises will target both the pelvic floor muscles and the abdominal muscles. The exercises will be divided into three phases, with progressively increasing difficulty each month. The progression will be achieved by increasing the load, the number of repetitions, and the complexity of the exercises.

1PFMT + Abd Group

Abdominal Hypopressive Technique Exercises BEHAVIORAL

Participants in this group will perform Hypopressive Abdominal Gymnastics exercises as proposed by Marcel Caufriez (1997). The training will last 12 weeks and be conducted in person, with supervision by a specialist physical therapist, in groups of up to four women. The training will take place after an initial evaluation and will consist of 24 sessions, held twice a week. The exercises will be divided into three phases, with progressively increasing difficulty each month. Progression will be achieved by changing body positions, increasing the number of repetitions, and extending the duration of inspiratory apnea.

Also known as: Hypopressive Exercises

AHG Group

Pelvic floor muscle training OTHER

Participants in this group will undergo 12 weeks of in-person training, supervised by a specialist physical therapist, in groups of up to four women. Specific exercises targeting the pelvic floor muscles will be performed, with voluntary and maximal contractions, without involving other muscle groups. The exercises will be divided into three phases, with progressively increasing difficulty each month. Progression will be achieved by increasing the load (transitioning from gravitational to antigravitational positions), increasing the number of repetitions, and combining sustained and rapid contractions to enhance the difficulty of execution.

PFMT Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Individuals assigned female at birth, who have a vagina, who are runners, and who experience urinary leakage during running.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have been running for at least six months
• Run at least 15 kilometers per week,
• Have no injuries that have prevented them from running for more than three weeks in the past six months
• Experience involuntary urinary leakage during running
• The women must have a pelvic floor muscle strength of ≥ 2 on the modified Oxford scale

You may not qualify if:

• Having a diagnosed neuromuscular disease that affects bladder function
• Having undergone previous pelvic or perineal surgeries for the correction of pelvic floor dysfunctions
• Having previously received physical therapy for the treatment of pelvic floor dysfunctions

Sponsors & Collaborators

• Federal University of Uberlandia: lead

Study Sites (1)

Benjamin Constant St, 1286

Uberlândia, Minas Gerais, 38400-678, Brazil

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

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: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor Ana Paula M. Resende, PT, PhD, Principal Investigator

Study Record Dates

• First Submitted: September 7, 2024
• First Posted: September 19, 2024
• Study Start: September 20, 2024
• Primary Completion: January 10, 2026
• Study Completion: March 10, 2026
• Last Updated: March 16, 2026

Record last verified: 2024-09

Locations

BR (1)