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

NCT07101731 | Recruiting

• 1 other identifier: SBU-RPHEE-2025-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Radical Prostatectomy; Urinary Incontinence; Erectile Dysfunction; Pelvic Floor Muscle Training; Hypopressive Exercises

Outcome Measures

Primary Outcomes (3)

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

  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.

  Baseline and 8 weeks

• Change in pelvic floor muscle strength measured by Modified Oxford Scale

  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.

  Baseline and 8 weeks

• Change in pelvic floor muscle endurance measured in seconds

  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.

  Baseline and Week 8

Secondary Outcomes (6)

• Change in erectile function measured by IIEF-5

  Baseline and 8 weeks

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

  Baseline and 8 weeks

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

  Baseline and 8 weeks

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

  Baseline and 8 weeks

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

  Baseline and 8 weeks

Study Arms (2)

Pelvic Floor Home Exercise + Supervised Hypopressive Exercise Group

EXPERIMENTAL

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

Behavioral: Pelvic Floor Muscle Training (PFMT); Behavioral: Hypopressive Exercises

Pelvic Floor Home Exercise Only Group

ACTIVE COMPARATOR

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

Behavioral: Pelvic Floor Muscle Training (PFMT)

Interventions

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.

Pelvic Floor Home Exercise + Supervised Hypopressive Exercise Group; Pelvic Floor Home Exercise Only Group

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.

Pelvic Floor Home Exercise + Supervised Hypopressive Exercise Group

Eligibility Criteria

• Age: 55 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bartın Unıversity: lead

Study Sites (1)

University of Health Sciences, Gülhane Training and Research Hospital

Ankara, Ankara, 06010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Incontinence; Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Central Study Contacts

Betül Erbay, M.Sc.

CONTACT

+905072650111; fztbetulerbay@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking was performed due to the nature of the intervention. Participants and investigators were aware of the group assignments. türkçesi
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: August 3, 2025
• Study Start: June 1, 2024
• Primary Completion: November 15, 2025
• Study Completion: November 15, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

TU (1)