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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age55+
SponsorBartın Unıversity

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

History of urinary incontinence before surgery

Congenital abnormalities of the urinary system

Presence of neurological disorders

History of transurethral resection of the prostate (TURP)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Pelvic Floor Home Exercise + Supervised Hypopressive Exercise GroupExperimental treatment 2 interventions
Group B: Pelvic Floor Home Exercise Only GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 8 weeks
2

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.

Time frame
Baseline and 8 weeks
3

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.

Time frame
Baseline and Week 8

Secondary outcomes

1

Change in erectile function measured by IIEF-5

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.

Time frame
Baseline and 8 weeks
2

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

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.

Time frame
Baseline and 8 weeks
3

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

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.

Time frame
Baseline and 8 weeks
4

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

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.

Time frame
Baseline and 8 weeks

Other outcomes

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