Post Prostatectomy IncontinencePFMTinPPUINCT07172854
Pelvic Floor Muscle Training With Aerobic Exercise and Relaxation After Radical Prostatectomy
A study testing Pelvic Floor Muscle Training, Aerobic Exercise and Relaxation Training in people with Post Prostatectomy Incontinence and Erectile Dysfunction Following Radical Prostatectomy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Post-prostatectomy urinary incontinence (PP-UI) and erectile dysfunction (ED) are common complications after radical prostatectomy, negatively affecting quality of life. Pelvic floor muscle training (PFMT) is widely recommended as the first-line conservative treatment, but recent evidence suggests that multimodal… Read more about this study
- Who is it for?
- Ages 40 to 65 years, men only
- Conditions the study is for
- Post Prostatectomy Incontinence, Erectile Dysfunction Following Radical Prostatectomy
- What is being tested?
- Pelvic Floor Muscle Training, Aerobic Exercise and Relaxation Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2025to 15 Jun 2026
- 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 40 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male participants aged 40 to 65 years
- Underwent nerve-sparing robotic radical prostatectomy within the past 12 months
- Ability to voluntarily contract pelvic floor muscles
- Cognitive capacity sufficient for cooperation with study assessments and interventions, as determined by the Montreal Cognitive Assessment (MoCA)
Who cannot join
- Presence of acute illness (e.g., urinary tract infection, respiratory infection, interstitial cystitis, bladder or gastrointestinal bleeding)
- Within the first 3 weeks after prostatectomy surgery (acute postoperative period)
- Neurological disorders or diagnosis of neurogenic bladder
- Diagnosed cognitive or psychiatric disorders
- Preoperative urinary incontinence or erectile dysfunction
- History of prior bladder or prostate surgery before prostatectomy
- Participation in pelvic floor muscle training within the last 6 months
- Refusal to participate or absence of signed informed consent form
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University
Altindağ, Ankara, (507) 431-9554
About this study
Official title: Radikal Prostatektomi Sonrasında Aerobik Egzersiz ve Gevşeme Eğitimlerinin Pelvik Taban Kas Eğitimine İlave Etkileri
Post-prostatectomy urinary incontinence (PP-UI) and erectile dysfunction (ED) are common complications after radical prostatectomy, negatively affecting quality of life. Pelvic floor muscle training (PFMT) is widely recommended as the first-line conservative treatment, but recent evidence suggests that multimodal, structured rehabilitation may further improve recovery.
This randomized controlled trial will investigate the additional effects of aerobic exercise and relaxation training combined with PFMT in men following nerve-sparing robotic-assisted radical prostatectomy. Forty-eight participants aged 40-65 years, within one year post-surgery, who demonstrate voluntary pelvic floor muscle contraction and sufficient cognitive function (MoCA), will be randomly assigned (1:1) to intervention or control groups.
Read more
All participants will receive standardized education and a 12-week supervised PFMT program with biofeedback and home-based exercises. The intervention group will additionally perform treadmill-based aerobic exercise three times per week and structured relaxation training once per week.
Primary outcomes include urinary symptoms (ICIQ-MLUTS), erectile function (IIEF-15), and prostate cancer-specific quality of life (EPIC). Secondary outcomes include pad test, ICIQ-SF, 6-minute walk test, MoCA, HADS, and adherence.
This non-commercial study aims to provide high-quality evidence supporting physiotherapy-based multimodal rehabilitation for improved pelvic health and quality of life in men after prostate cancer surgery.
Read the detailed description
Post-prostatectomy urinary incontinence (PP-UI) and erectile dysfunction (ED) are among the most common and distressing complications following radical prostatectomy (RP), significantly affecting the quality of life and psychosocial well-being of prostate cancer survivors. Although pelvic floor muscle training (PFMT) is widely recommended as the first-line conservative approach to manage these complications, recent evidence highlights the importance of multimodal, structured rehabilitation programs supervised by physiotherapists to optimize continence recovery and sexual function.
This randomized controlled trial aims to investigate the additional effects of aerobic exercise and relaxation training when combined with PFMT in men with urinary incontinence and erectile dysfunction following nerve-sparing robotic-assisted radical prostatectomy. The study is designed as a two-arm parallel-group, single-center trial involving 48 male participants aged between 40 and 65 years. Eligible participants must be within one year post-surgery, demonstrate voluntary pelvic floor muscle contraction, and exhibit sufficient cognitive function as assessed by the Montreal Cognitive Assessment (MoCA).
Participants will be randomly allocated (1:1) into either the intervention group or the control group using a computer-generated block randomization procedure. All participants will receive standardized patient education and a 12-week PFMT protocol guided by biofeedback. The PFMT sessions will be conducted individually by a physiotherapist three times per week and include a home-based exercise program monitored through an exercise diary.
In the intervention group, aerobic exercise and relaxation training will be added to PFMT. Aerobic exercise will consist of treadmill walking at moderate intensity (Modified Borg RPE scale 4-6) for 60 minutes (10 min warm-up, 40 min loading, 10 min cool-down), three times per week for 12 weeks. Relaxation training will be conducted once weekly and will include guided breathing, imagery, and meditation techniques in a quiet, dimly lit environment. Patients will be encouraged to practice these relaxation techniques at home using a standardized script.
Assessments will be performed at baseline and at the end of the 12-week intervention. Primary outcome measures include changes in urinary symptoms (ICIQ-MLUTS), erectile function (IIEF-15), and prostate cancer-specific quality of life (EPIC). Secondary outcomes include objective incontinence severity (1-hour pad test), subjective continence impact (ICIQ-SF), functional exercise capacity (6-minute walk test), psychological status (HADS), and exercise adherence (self-reported exercise diary).
All assessments will be carried out during routine clinical visits. The study does not involve any pharmaceutical or implantable medical products and has no placebo arm. No financial incentives will be provided to participants.
This academic, non-commercial trial is expected to generate high-quality evidence to support the role of multimodal physiotherapy in improving pelvic health outcomes in men following prostate cancer surgery. Findings may guide clinicians and healthcare providers in designing structured, holistic rehabilitation protocols that target both physical and emotional recovery in cancer survivorship.
- Being tested
- Pelvic Floor Muscle Training, Aerobic Exercise, Relaxation Training, Patient Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Muscle TrainingOther
Supervised PFMT with biofeedback, 3 times per week for 12 weeks, plus home exercises.
Aerobic ExerciseOther
Treadmill walking, moderate intensity (Borg 4-6), 60 minutes/session, 3 times per week for 12 weeks.
Relaxation TrainingOther
Guided breathing, imagery, and meditation, once weekly for 12 weeks, in addition to home practice.
Patient EducationOther
Standardized education on urinary incontinence, pelvic anatomy, lifestyle modification, and stress management.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Intervention group Receives: Other: Pelvic Floor Muscle Training; Other: Aerobic Exercise; Other: Relaxation Training; Other: Patient Education |
| Control Group | Active comparator | Control Group Receives: Other: Pelvic Floor Muscle Training; Other: Patient Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urinary symptoms
Assessment of changes in three primary domains:
Lower urinary tract symptoms will be assessed using the International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS). Scores range from 0 to 48, with higher scores indicating more severe urinary symptoms.
All outcomes will be measured at baseline and at the end of the 12-week intervention period.
Measured: Baseline and at 12 weeks post-intervention
Change in Erectile Function (IIEF-15)
Erectile function and sexual health will be assessed using the International Index of Erectile Function (IIEF-15). Scores range from 5 to 75, with higher scores indicating better erectile function.
Measured: Baseline and 12 weeks post-intervention
Change in Prostate Cancer-Specific Quality of Life (EPIC)
Prostate cancer-related quality of life will be measured using the Expanded Prostate Cancer Index Composite (EPIC). Scores range from 0 to 100, with higher scores indicating better quality of life.
Measured: Baseline and 12 weeks post-intervention
Secondary outcomes (5)
Change in 1-Hour Pad Test Result
Objective severity of urinary incontinence will be measured using the 1-hour pad test. The pad is weighed before and after the test; higher weight gain indicates more leakage.
Measured: Baseline and 12 weeks
Change in ICIQ-Short Form (ICIQ-SF) Score
The subjective impact of urinary incontinence on daily life will be assessed using the ICIQ-Short Form (ICIQ-SF). Scores range from 0 to 21, with higher scores indicating greater impact and worse continence-related quality of life.
Measured: Baseline and 12 weeks
Change in Hospital Anxiety and Depression Scale (HADS) Scores
Psychological status will be assessed using the Hospital Anxiety and Depression Scale (HADS), which includes anxiety (HADS-A) and depression (HADS-D) subscales. Each subscale ranges from 0 to 21. Higher scores indicate greater emotional distress (worse outcomes).
Measured: Baseline and 12 weeks
Change in 6-Minute Walk Test Distance
Functional exercise capacity will be assessed using the 6-Minute Walk Test (6MWT). The total distance walked in meters will be recorded; greater distance indicates better functional capacity.
Measured: Baseline and 12 weeks
Exercise Adherence
Exercise adherence will be monitored through a self-reported exercise diary. Participants will log completion of home-based pelvic floor, aerobic, and relaxation exercises. Adherence rate will be calculated as a percentage of prescribed sessions completed.
Measured: Throughout 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start15 Apr 2025
- Primary completion15 Apr 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Prostatectomy IncontinenceStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ege Nur ATABEY, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172854
- Sponsor's protocol ID
- KA-24085
- Other IDs
- TUBITAK
- Acronym
- PFMTinPPUI
- Status last verified
- Apr 2025
- First submitted
- 4 Aug 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radikal Prostatektomi Sonrasında Aerobik Egzersiz ve Gevşeme Eğitimlerinin Pelvik Taban Kas Eğitimine İlave Etkileri
- ClinicalTrials.gov ID
- NCT07172854
- Acronym / sponsor ID
- PFMTinPPUI / KA-24085
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 15 Sep 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.
Post-prostatectomy urinary incontinence (PP-UI) and erectile dysfunction (ED) are common complications after radical prostatectomy, negatively affecting quality of life. Pelvic floor muscle training (PFMT) is widely recommended as the first-line conservative treatment, but recent evidence suggests that multimodal, structured rehabilitation may further improve recovery.
This randomized controlled trial will investigate the additional effects of aerobic exercise and relaxation training combined with PFMT in men following nerve-sparing robotic-assisted radical prostatectomy. Forty-eight participants aged 40-65 years, within one year post-surgery, who demonstrate voluntary pelvic floor muscle contraction and sufficient cognitive function (MoCA), will be randomly assigned (1:1) to intervention or control groups.
All participants will receive standardized education and a 12-week supervised PFMT program with biofeedback and home-based exercises. The intervention group will additionally perform treadmill-based aerobic exercise three times per week and structured relaxation training once per week.
Primary outcomes include urinary symptoms (ICIQ-MLUTS), erectile function (IIEF-15), and prostate cancer-specific quality of life (EPIC). Secondary outcomes include pad test, ICIQ-SF, 6-minute walk test, MoCA, HADS, and adherence.
This non-commercial study aims to provide high-quality evidence supporting physiotherapy-based multimodal rehabilitation for improved pelvic health and quality of life in men after prostate cancer surgery.
Detailed description
Post-prostatectomy urinary incontinence (PP-UI) and erectile dysfunction (ED) are among the most common and distressing complications following radical prostatectomy (RP), significantly affecting the quality of life and psychosocial well-being of prostate cancer survivors. Although pelvic floor muscle training (PFMT) is widely recommended as the first-line conservative approach to manage these complications, recent evidence highlights the importance of multimodal, structured rehabilitation programs supervised by physiotherapists to optimize continence recovery and sexual function.
This randomized controlled trial aims to investigate the additional effects of aerobic exercise and relaxation training when combined with PFMT in men with urinary incontinence and erectile dysfunction following nerve-sparing robotic-assisted radical prostatectomy. The study is designed as a two-arm parallel-group, single-center trial involving 48 male participants aged between 40 and 65 years. Eligible participants must be within one year post-surgery, demonstrate voluntary pelvic floor muscle contraction, and exhibit sufficient cognitive function as assessed by the Montreal Cognitive Assessment (MoCA).
Participants will be randomly allocated (1:1) into either the intervention group or the control group using a computer-generated block randomization procedure. All participants will receive standardized patient education and a 12-week PFMT protocol guided by biofeedback. The PFMT sessions will be conducted individually by a physiotherapist three times per week and include a home-based exercise program monitored through an exercise diary.
In the intervention group, aerobic exercise and relaxation training will be added to PFMT. Aerobic exercise will consist of treadmill walking at moderate intensity (Modified Borg RPE scale 4-6) for 60 minutes (10 min warm-up, 40 min loading, 10 min cool-down), three times per week for 12 weeks. Relaxation training will be conducted once weekly and will include guided breathing, imagery, and meditation techniques in a quiet, dimly lit environment. Patients will be encouraged to practice these relaxation techniques at home using a standardized script.
Assessments will be performed at baseline and at the end of the 12-week intervention. Primary outcome measures include changes in urinary symptoms (ICIQ-MLUTS), erectile function (IIEF-15), and prostate cancer-specific quality of life (EPIC). Secondary outcomes include objective incontinence severity (1-hour pad test), subjective continence impact (ICIQ-SF), functional exercise capacity (6-minute walk test), psychological status (HADS), and exercise adherence (self-reported exercise diary).
All assessments will be carried out during routine clinical visits. The study does not involve any pharmaceutical or implantable medical products and has no placebo arm. No financial incentives will be provided to participants.
This academic, non-commercial trial is expected to generate high-quality evidence to support the role of multimodal physiotherapy in improving pelvic health outcomes in men following prostate cancer surgery. Findings may guide clinicians and healthcare providers in designing structured, holistic rehabilitation protocols that target both physical and emotional recovery in cancer survivorship.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Pelvic Floor Muscle Training, Other: Aerobic Exercise, Other: Relaxation Training, Other: Patient EducationIntervention group |
| Control Group | Active comparator | Other: Pelvic Floor Muscle Training, Other: Patient EducationControl Group |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male participants aged 40 to 65 years
- Underwent nerve-sparing robotic radical prostatectomy within the past 12 months
- Ability to voluntarily contract pelvic floor muscles
- Cognitive capacity sufficient for cooperation with study assessments and interventions, as determined by the Montreal Cognitive Assessment (MoCA)
Key exclusion criteria (8 listed)
- Presence of acute illness (e.g., urinary tract infection, respiratory infection, interstitial cystitis, bladder or gastrointestinal bleeding)
- Within the first 3 weeks after prostatectomy surgery (acute postoperative period)
- Neurological disorders or diagnosis of neurogenic bladder
- Diagnosed cognitive or psychiatric disorders
- Preoperative urinary incontinence or erectile dysfunction
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 TrainingSupervised PFMT with biofeedback, 3 times per week for 12 weeks, plus home exercises. | Other | Control Group, Intervention Group |
| Aerobic ExerciseTreadmill walking, moderate intensity (Borg 4-6), 60 minutes/session, 3 times per week for 12 weeks. | Other | Intervention Group |
| Relaxation TrainingGuided breathing, imagery, and meditation, once weekly for 12 weeks, in addition to home practice. | Other | Intervention Group |
| Patient EducationStandardized education on urinary incontinence, pelvic anatomy, lifestyle modification, and stress management. | Other | Control Group, Intervention Group |
Primary outcome
Change in urinary symptoms
Time frame: Baseline and at 12 weeks post-intervention
Assessment of changes in three primary domains: Lower urinary tract symptoms will be assessed using the International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS). Scores range from 0 to 48, with higher scores indicating more severe urinary symptoms. All outcomes will be measured at baseline and at the end of the 12-week intervention period.
Change in Erectile Function (IIEF-15)
Time frame: Baseline and 12 weeks post-intervention
Erectile function and sexual health will be assessed using the International Index of Erectile Function (IIEF-15). Scores range from 5 to 75, with higher scores indicating better erectile function.
Change in Prostate Cancer-Specific Quality of Life (EPIC)
Time frame: Baseline and 12 weeks post-intervention
Prostate cancer-related quality of life will be measured using the Expanded Prostate Cancer Index Composite (EPIC). Scores range from 0 to 100, with higher scores indicating better quality of life.
5 secondary outcomes
Change in 1-Hour Pad Test Result
Time frame: Baseline and 12 weeks
Change in ICIQ-Short Form (ICIQ-SF) Score
Time frame: Baseline and 12 weeks
Change in Hospital Anxiety and Depression Scale (HADS) Scores
Time frame: Baseline and 12 weeks
Change in 6-Minute Walk Test Distance
Time frame: Baseline and 12 weeks
Exercise Adherence
Time frame: Throughout 12-week intervention
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 23 Sep 2026.
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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, Aerobic Exercise and Relaxation Training in people with Post Prostatectomy Incontinence and Erectile Dysfunction Following Radical Prostatectomy, run by Hacettepe University 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 4 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 23 Sep 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 urinary symptoms (time frame: Baseline and at 12 weeks post-intervention). The study lists 3 primary outcomes in all. 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 23 Sep 2026.