Effects of Hypopressive Exercises on Urinary Incontinence and Erectile Dysfunction After Radical Prostatectomy

NCT ID: NCT07101731

Last Updated: 2025-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-11-15

Brief Summary

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This randomized controlled trial investigates the effects of hypopressive exercises on urinary incontinence and erectile dysfunction in men following radical prostatectomy. Participants will be randomly assigned to one of two groups: a control group receiving home-based pelvic floor muscle exercises and an experimental group receiving both pelvic floor muscle exercises and supervised hypopressive exercises twice per week. The study aims to determine whether the addition of hypopressive techniques, which target coordinated activation of the pelvic floor and abdominal muscles without increasing intra-abdominal pressure, offers greater improvements in urinary and sexual function. Primary outcomes include pelvic floor muscle strength and endurance, while secondary outcomes include urinary incontinence severity, erectile function, and quality of life.

Detailed Description

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Prostate cancer is one of the most common malignancies among men, with radical prostatectomy being a widely used treatment option. However, post-surgical complications such as urinary incontinence and erectile dysfunction significantly affect the quality of life of these patients. Pelvic floor muscle training (PFMT) is frequently recommended to manage these complications, yet its standalone effectiveness remains debatable.

Recent literature highlights that optimal pelvic floor function is achieved through coordinated activation with abdominal and respiratory muscles, such as the transversus abdominis, rectus abdominis, and diaphragm. Despite this, conventional PFMT protocols for post-prostatectomy patients often neglect this integrated muscle synergy. Hypopressive exercises, which involve postural techniques with apnea and breathing control, have been shown to activate both pelvic floor and abdominal muscles without increasing intra-abdominal pressure.

This study aims to evaluate the effects of hypopressive exercises, in addition to standard pelvic floor exercises, on pelvic floor muscle strength, urinary incontinence severity, and erectile function in post-prostatectomy men. The study will be conducted with two arms: a control group performing home-based pelvic floor exercises and an experimental group performing the same PFMT along with supervised hypopressive exercises twice weekly for 8 weeks. Outcomes will be assessed pre- and post-intervention, focusing on both physical performance and patient-reported measures.

Conditions

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Prostate Cancer (Post Prostatectomy) Urinary Incontinence Erectile Dysfunction Following Radical Prostatectomy Pelvic Floor Muscle Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No masking was performed due to the nature of the intervention. Participants and investigators were aware of the group assignments. türkçesi

Study Groups

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Pelvic Floor Home Exercise + Supervised Hypopressive Exercise Group

Participants will perform daily home-based pelvic floor muscle exercises and also attend supervised hypopressive exercise sessions twice a week for 8 weeks.

Group Type EXPERIMENTAL

Pelvic Floor Muscle Training (PFMT)

Intervention Type BEHAVIORAL

Participants in the control group will receive an individualized home-based pelvic floor muscle exercise program. Exercises will be performed once daily for 8 weeks, focusing on voluntary pelvic floor contractions in various positions (supine, sitting, standing). Participants will receive initial training and written instructions from a physiotherapist, and will be contacted weekly to monitor adherence.

Hypopressive Exercises

Intervention Type BEHAVIORAL

Participants in the experimental group will attend supervised hypopressive exercise sessions twice per week for 8 weeks. These sessions involve specific postural sequences combined with breathing and apnea techniques aimed at reducing intra-abdominal pressure while activating pelvic floor and abdominal muscles. Sessions will be led by a physiotherapist and adapted based on individual performance and posture tolerance.

Pelvic Floor Home Exercise Only Group

Participants will be instructed to perform home-based pelvic floor muscle exercises daily for 8 weeks. No supervised exercise sessions will be provided.

Group Type ACTIVE_COMPARATOR

Pelvic Floor Muscle Training (PFMT)

Intervention Type BEHAVIORAL

Participants in the control group will receive an individualized home-based pelvic floor muscle exercise program. Exercises will be performed once daily for 8 weeks, focusing on voluntary pelvic floor contractions in various positions (supine, sitting, standing). Participants will receive initial training and written instructions from a physiotherapist, and will be contacted weekly to monitor adherence.

Interventions

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Pelvic Floor Muscle Training (PFMT)

Participants in the control group will receive an individualized home-based pelvic floor muscle exercise program. Exercises will be performed once daily for 8 weeks, focusing on voluntary pelvic floor contractions in various positions (supine, sitting, standing). Participants will receive initial training and written instructions from a physiotherapist, and will be contacted weekly to monitor adherence.

Intervention Type BEHAVIORAL

Hypopressive Exercises

Participants in the experimental group will attend supervised hypopressive exercise sessions twice per week for 8 weeks. These sessions involve specific postural sequences combined with breathing and apnea techniques aimed at reducing intra-abdominal pressure while activating pelvic floor and abdominal muscles. Sessions will be led by a physiotherapist and adapted based on individual performance and posture tolerance.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Male individuals diagnosed with prostate cancer who have undergone radical prostatectomy
* Experiencing both urinary incontinence and erectile dysfunction
* Age \> 55 years
* A score of 24 or higher on the Mini-Mental State Examination (MMSE)
* Literate (able to read and write)
* Willingness to participate in the study (signed informed consent)
* Ability to voluntarily contract pelvic floor muscles
* Ability to cooperate with the assessments and interventions used in the study

Exclusion Criteria

* History of urinary incontinence before surgery
* Congenital abnormalities of the urinary system
* Presence of neurological disorders
* History of transurethral resection of the prostate (TURP)
* Diagnosis of chronic obstructive pulmonary disease (COPD) and/or chronic restrictive pulmonary disease
* History of inguinal hernia
* Previous or current history of radiation therapy
* Surgical or postoperative complications that prevent early physiotherapy intervention (e.g., urinary tract infection, bladder neck stenosis)
Minimum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bartın Unıversity

OTHER

Sponsor Role lead

Responsible Party

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Betül ERBAY

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Health Sciences, Gülhane Training and Research Hospital

Ankara, Ankara, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Betül Erbay, M.Sc.

Role: CONTACT

+905072650111

Facility Contacts

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Betül Erbay, M.Sc.

Role: primary

+095072650111

Other Identifiers

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SBU-RPHEE-2025-01

Identifier Type: -

Identifier Source: org_study_id

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