Prostate Cancer (Post Prostatectomy)NCT07101731
Effects of Hypopressive Exercises on Urinary Incontinence and Erectile Dysfunction After Radical Prostatectomy
A study testing Pelvic Floor Muscle Training (PFMT) and Hypopressive Exercises in people with Prostate Cancer (Post Prostatectomy) and Urinary Incontinence, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older, men only
- Conditions the study is for
- Prostate Cancer (Post Prostatectomy), Urinary Incontinence, Erectile Dysfunction Following Radical Prostatectomy
- What is being tested?
- Pelvic Floor Muscle Training (PFMT) and Hypopressive Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Gülhane Training and Research Hospital
Ankara, Ankara, 06010
About this study
Official title: The Effects of Hypopressive Exercises on Urinary Incontinence and Erectile Dysfunction After Radical Prostatectomy: A Randomized Controlled 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.
Read the detailed description
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
- Prostate Cancer (Post Prostatectomy), Urinary Incontinence, Erectile Dysfunction Following Radical Prostatectomy, Pelvic Floor Muscle Training
- Being tested
- Pelvic Floor Muscle Training (PFMT), Hypopressive Exercises
- Keywords
- Radical Prostatectomy, Urinary Incontinence, Erectile Dysfunction, Pelvic Floor Muscle Training, Hypopressive Exercises
- Medical subject headings
- Prostatic Neoplasms, Urinary Incontinence, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Muscle Training (PFMT)Behavioural
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 ExercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Pelvic Floor Muscle Training (PFMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ICIQ-SF Total Score
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.
Measured: Baseline and 8 weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: Baseline and 8 weeks
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.
Measured: Baseline and 8 weeks
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.
Measured: Baseline and 8 weeks
Adherence to the Exercise Programme
Adherence to the home-based pelvic floor muscle training programme was assessed in both groups using participant exercise diaries. Adherence was calculated as the percentage of prescribed home-based PFMT sets completed during the eight-week intervention. Higher percentages indicate greater adherence to the prescribed home-based PFMT programme.
Measured: Throughout the 8-week intervention
Treatment Success
Treatment success was defined as a reduction of at least 50% in the 1-hour pad-test value from baseline to Week 8. Participants were classified as responders or non-responders.
Measured: Week 8 compared with baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Jun 2024
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Post Prostatectomy)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bartın Unıversity
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül ERBAY, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101731
- Sponsor's protocol ID
- SBU-RPHEE-2025-01
- Status last verified
- Aug 2026
- First submitted
- 18 Jul 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The individual participant data (IPD) sharing decision has not been finalized. Although publication of the study results is planned, the possibility of sharing de-identified IPD with other researchers will depend on institutional policies, ethical approvals, and publication guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Hypopressive Exercises on Urinary Incontinence and Erectile Dysfunction After Radical Prostatectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07101731
- Acronym / sponsor ID
- SBU-RPHEE-2025-01
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bartın UnıversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Home Exercise + Supervised Hypopressive Exercise Group | Experimental | Behavioral: Pelvic Floor Muscle Training (PFMT), Behavioral: Hypopressive ExercisesParticipants will perform daily home-based pelvic floor muscle exercises and also attend supervised hypopressive exercise sessions twice a week for 8 weeks. |
| Pelvic Floor Home Exercise Only Group | Active comparator | Behavioral: Pelvic Floor Muscle Training (PFMT)Participants will be instructed to perform home-based pelvic floor muscle exercises daily for 8 weeks. No supervised exercise sessions will be provided. |
Who may qualify
- Ages
- 55 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Pelvic Floor Home Exercise + Supervised Hypopressive Exercise Group, Pelvic Floor Home Exercise Only Group |
| Hypopressive ExercisesParticipants 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. | Behavioural | Pelvic Floor Home Exercise + Supervised Hypopressive Exercise Group |
Primary outcome
Change in ICIQ-SF Total Score
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.
6 secondary outcomes
Change in erectile function measured by IIEF-5
Time frame: Baseline and 8 weeks
Change in pelvic floor muscle strength measured by Modified Oxford Scale
Time frame: Baseline and 8 weeks
Change in urinary incontinence severity measured by 1-hour Pad Test
Time frame: Baseline and 8 weeks
Change in quality of life measured by King's Health Questionnaire
Time frame: Baseline and 8 weeks
Adherence to the Exercise Programme
Time frame: Throughout the 8-week intervention
Treatment Success
Time frame: Week 8 compared with baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Undecided. The individual participant data (IPD) sharing decision has not been finalized. Although publication of the study results is planned, the possibility of sharing de-identified IPD with other researchers will depend on institutional policies, ethical approvals, and publication guidelines.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Floor Muscle Training (PFMT) and Hypopressive Exercises in people with Prostate Cancer (Post Prostatectomy) and Urinary Incontinence, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ICIQ-SF Total Score (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.