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NCT Number: NCT07101731

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

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.

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Key information

Conditions

Prostate Cancer (Post Prostatectomy) Erectile Dysfunction Erectile Dysfunction Following Radical Prostatectomy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Pelvic Floor Muscle Training Prostatic Diseases Prostatic Neoplasms Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urological Manifestations

Age range

55 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences, Gülhane Training and Research Hospital

Ankara, 06010, Turkey (Türkiye)

Location status: Recruiting

Location contact

Betül Erbay, M.Sc.

CONTACT

[email protected]

+095072650111

Necmiye Ün Yıldırım, Ph.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pelvic Floor Muscle Training (PFMT)

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

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.

Primary outcomes

  1. Change in urinary incontinence severity measured by 1-hour Pad Test

    Time frame: Baseline and 8 weeks

    The 1-hour Pad Test, standardized by the International Continence Society (ICS), will be used to objectively assess urinary leakage. A weight gain of >1g indicates a positive test. Severity will be classified as mild (<2g), moderate (2-10g), severe (10-50g), or very severe (>50g). The difference in pad weight pre- and post-intervention will be recorded.

  2. Change in pelvic floor muscle strength measured by Modified Oxford Scale

    Time frame: Baseline and 8 weeks

    Pelvic floor muscle strength will be assessed by manual digital palpation in a side-lying position with knees flexed at 45 degrees. Strength will be scored using the Modified Oxford Scale, which ranges from 0 (no contraction) to 5 (strong contraction). Higher scores indicate better pelvic floor muscle strength.

  3. Change in pelvic floor muscle endurance measured in seconds

    Time frame: Baseline and Week 8

    Pelvic floor muscle endurance will be assessed by instructing participants to sustain a maximal voluntary pelvic floor muscle contraction for as long as possible in a side-lying position with knees flexed at 45 degrees. The duration (in seconds) for which the contraction is maintained without loss of force will be recorded. Longer durations indicate greater endurance.

Secondary outcomes

  1. Change in erectile function measured by IIEF-5

    Time frame: Baseline and 8 weeks

    Erectile function will be assessed using the 5-item version of the International Index of Erectile Function (IIEF-5). Total scores range from 5 to 25, with lower scores indicating more severe erectile dysfunction. The change in total score from baseline to post-intervention will be analyzed.

  2. Change in urinary incontinence severity and impact measured by ICIQ-SF

    Time frame: Baseline and 8 weeks

    The International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) will be used to assess perceived severity and quality of life impact of urinary incontinence. The total score is based on responses to questions 3, 4, and 5 (range: 0-21). Higher scores indicate more severe incontinence.

  3. Change in quality of life measured by King's Health Questionnaire

    Time frame: Baseline and 8 weeks

    The King's Health Questionnaire will be used to assess health-related quality of life in individuals with urinary incontinence. The questionnaire includes multiple subdomains, with scores ranging from 0 (best health status) to 100 (worst). A decrease in score indicates improvement.

  4. Change in urinary frequency and incontinence episodes measured by 3-day bladder diary

    Time frame: Baseline and 8 weeks

    A 3-day bladder diary will be used to document frequency of urination, incontinence episodes, and fluid intake. Data from weekdays and weekends will be averaged to calculate daily means. Change in urination and leakage frequency from baseline to Week 8 will be analyzed.

  5. Change in perceived urinary symptom severity measured by Patient Global Impression of Severity (PGI-S)

    Time frame: Baseline and 8 weeks

    Participants will rate the perceived severity of urinary incontinence using the Patient Global Impression of Severity (PGI-S) scale. The PGI-S is a 4-point scale ranging from 1 (normal) to 4 (severe). Higher scores indicate worse perceived urinary symptom severity. Change in score from baseline to Week 8 will be used to evaluate subjective symptom burden.

  6. Perceived improvement in urinary symptoms measured by Patient Global Impression of Improvement (PGI-I)

    Time frame: Week 8

    Participants will evaluate the overall change in their urinary symptoms using the Patient Global Impression of Improvement (PGI-I) scale. The PGI-I is a 7-point scale ranging from 1 (very much better) to 7 (very much worse). Lower scores indicate greater perceived improvement. This measure will be used to assess subjective global change in urinary symptoms after the intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Betül Erbay, M.Sc.

CONTACT

[email protected]

+905072650111

Sponsors and collaborators

Lead sponsor

Bartın Unıversity

Other

Registry information

Official study title

The Effects of Hypopressive Exercises on Urinary Incontinence and Erectile Dysfunction After Radical Prostatectomy: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 3, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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