AzTrials
AzTrials

IncontinenceNCT06126874

Additional Effects of Aerobic and Resistance Exercises to Pelvic Floor Muscle Training After Radical Prostatectomy

A study testing Patient Education, Pelvic Floor Muscle Training and Aerobic Exercise Training in people with Incontinence and Erectile Dysfunction Following Radical Prostatectomy, run by Hacettepe University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

In the literature, studies about urinary symptoms after radical prostatectomy (RP) are generally focused on urinary incontinence (UI), and studies about sexual symptoms are focused on erectile dysfunction (ED). Read more about this study

Who is it for?
Ages 40 years and older, men only
What is being tested?
Patient Education, Pelvic Floor Muscle Training and Aerobic Exercise Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Mar 2024to 15 Jan 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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individuals with localized prostate cancer (Stage I-II) undergoing Robot-Assisted Laparoscopic or Open Bilateral Nerve-Sparing Radical Prostatectomy
  • being married or having a partner
  • lack of cooperation problems with the assessments and interventions in the study
  • Being 40 years or older

Who cannot join

  • Acute disease status (e.g. urinary tract infection, respiratory infection, presence of interstitial cystitis, bladder or gastrointestinal bleeding),
  • Acute surgical condition (within the first 3 weeks after prostatectomy),
  • Presence of neurological disease or neurogenic bladder,
  • Preoperative incontinence,
  • Bladder or other prostate surgery prior to prostatectomy,
  • Preoperative/postoperative pelvic radiotherapy,
Show all 9Show fewer
  • Reporting preoperative ED or sexual dysfunction other than ED,
  • Have any medical condition that may limit their exercise training,
  • Individuals over 65 years of age with a Mini Mental Test score of less than 24 (a score of less than 24 indicates mild/moderate dementia)

Trial locations and contacts

1 site in 1 country.

Serap Özgül, PhD contact

05339390803

serapky@yahoo.com

Turkey (Türkiye)1 site

  • Mustafa Enis Dilekmen

    Ankara, 06100

    Mustafa Enis Dilekmen, 05543809199, enisdilekmen507@gmail.com

    Naşide Mangır

Other trials in Turkey (Türkiye)

About this study

Official title: Additional Effects of Aerobic and Resistance Exercise Training to Pelvic Floor Muscle Training in Urinary Incontinence and Erectile Dysfunction After Radical Prostatectomy

In the literature, studies about urinary symptoms after radical prostatectomy (RP) are generally focused on urinary incontinence (UI), and studies about sexual symptoms are focused on erectile dysfunction (ED). In the management of these symptoms, the effects of pharmacological agents (duloxetine/antimuscarinics and PDE5-I) and/or local approaches (pelvic floor muscle training-PFMT, vacuum erection devices) have been emphasized. In these studies, the results are contradictory and the level of evidence is low. The effects of aerobic and resistance exercise training on urinary, sexual and general health after RP have not been revealed from a holistic and multidisciplinary perspective. Therefore, the aim of this study was to investigate the additional effects of aerobic and resistance exercise trainings to pelvic floor muscle training on urinary incontinence and erectile dysfunction after radical prostatectomy in a randomized controlled design.

The study will include volunteers aged 40 years and older (Mini Mental test score of 24 and above for individuals aged 65 years and older) with symptoms of UI and/or ED after RP. The study is designed as a randomized controlled trial. Individuals who meet the inclusion criteria and agree to participate in the study will be randomly assigned to 2 separate groups. Subjects in the research group will receive patient education, PFMT, and aerobic and resistance exercise trainings; subjects in the control group will receive only patient education and PFMT. The study period is 12 weeks. Individuals will be evaluated at 2 separate time periods, at the beginning of the study and at the end of the 12th week.

Read the detailed description

In the literature, studies about urinary symptoms after radical prostatectomy (RP) are generally focused on urinary incontinence (UI), and studies about sexual symptoms are focused on erectile dysfunction (ED). In the management of these symptoms, the effects of pharmacological agents (duloxetine/antimuscarinics and PDE5-I) and/or local approaches (pelvic floor muscle training-PFMT, vacuum erection devices) have been emphasized. In these studies, the results are contradictory and the level of evidence is low. The effects of aerobic and resistance exercise training on urinary, sexual and general health after RP have not been revealed from a holistic and multidisciplinary perspective. Therefore, the aim of this study was to investigate the additional effects of aerobic and resistance exercise trainings to pelvic floor muscle training on urinary incontinence and erectile dysfunction after radical prostatectomy in a randomized controlled design.The hypotheses of the study are as follows:

  • H1: After radical prostatectomy, aerobic and resistance exercise trainings in addition to pelvic floor muscle training (PFMT) provides greater improvement in objective UI severity, urinary symptoms and incontinence-specific quality of life.
  • H2: After radical prostatectomy, aerobic and resistance exercise trainings in addition to PFMT provides greater improvement in in penile length.
  • H3: After radical prostatectomy, aerobic and resistance exercise trainings in addition to PFMT provides greater improvement in erectile function and sexual health.
  • H4: After radical prostatectomy, aerobic and resistance exercise trainings in addition to PFMT provides greater improvement in peripheral muscle strength.
  • H5: After radical prostatectomy, aerobic and resistance exercise trainings in addition to PFMT provides greater improvement in functional exercise capacity.
  • H6: After radical prostatectomy, aerobic and resistance exercise trainings in addition to PFMT provides greater improvement in general health and quality of life.

The study will include volunteers aged 40 years and older (Mini Mental test score of 24 and above for individuals aged 65 years and older) with symptoms of UI and/or ED after RP. The study is designed as a randomized controlled trial. Individuals who meet the inclusion criteria and agree to participate in the study will be randomly assigned to 2 separate groups. Subjects in the research group will receive patient education, PFMT, and aerobic and resistance exercise trainings; subjects in the control group will receive only patient education and PFMT. The study period is 12 weeks. Individuals will be evaluated at 2 separate time periods, at the beginning of the study and at the end of the 12th week. Subjective severity of incontinence and its impact on life will be assessed with the International Consultation Incontinence Questionnaire-Short Form (ICIQ-SF). The International Consultation on Incontinence Questionnaire-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) scale will be used to question the severity of lower urinary tract symptoms. Erectile function and sexual function will be questioned with the International Erectile Function Form -15 (IIEF-15). Depression Anxiety Stress Scale-21 (DASS-21) will be used to evaluate the depression, anxiety and stress levels of the patients. The World Health Organization Quality of Life Questionnaire-Short Form (WHOQOL-BREF) will be used to question the general quality of life of the individuals. Objective severity of incontinence will be evaluated with a 1-hour pad test. Peripheral muscle strength will be evaluated with a hand-held dynamometer and functional exercise capacity of the individuals will be evaluated by 6-Minute Walking Test (6-MWT).

Being tested
Patient Education, Pelvic Floor Muscle Training, Aerobic Exercise Training, Resistance Exercise Training
Keywords
men's health, radical prostatectomy, urinary incontinence, erectile dysfunction, pelvic floor muscle training, aerobic exercise, resistance exercise, Kegel exercise
Medical subject headings
Urinary Incontinence, Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient EducationOther

    Individuals in both study groups will be provided with patient education through verbal and visual presentations. In the content of patient education; information about the importance of the research topic and the content of the study through anatomical models and short animations, lifestyle recommendations for urinary incontinence symptoms (avoiding bladder irritants such as alcohol, caffeine, tea, spicy foods, acidic foods and chocolate, regulating water / fluid consumption, recommendations for attention to bowel regularity and increasing physical activity levels) and recommendations for sexual functioning (coitus positions that facilitate erection, recommendations for reshaping the sexual schema, recommendations for the physical dimension of sexual health) will be given.

  • Pelvic Floor Muscle TrainingOther

    In PFMT, voluntary maximal and submaximal contractions for strength and endurance training of pelvic floor muscles will be taught and individuals will continue PFMT as a home exercise program. In the first 2 weeks of PFMT, individuals will perform 3 sessions of exercise per day. In each 2-week control, the number of sessions will be increased by 1 session and PFMT application will be completed with 5 sessions per day in the study.

  • Aerobic Exercise TrainingOther

    Aerobic exercise training will be planned 3 days a week, 1 day on the routine clinic day with a treadmill ergometer and 2 days as a home program in the form of brisk walking outside the clinic (e.g. outdoors or in a suitable environment).The intensity of aerobic exercise training will be planned according to the Maximal Heart Rate (MHR) method and Modified Borg Scale (MBS). In the first 2 weeks in the clinic, training will be started with 50 min (+10 min warm-up and cool-down) at 60% of the MHR, the exercise intensity will be increased by 5% every 2 weeks, and the program will be terminated by providing exercise training at 85% of the MHR in the 10th-12th week. Patients will be asked to adjust the intensity of aerobic exercise outside the clinic to correspond to the 12-14 (slightly difficult) degree of perceived fatigue according to the MBS.

  • Resistance Exercise TrainingOther

    Resisted exercise training will be planned 2 days a week, 1 day in the clinic and 1 day outside the clinic as a home program, and 12 different exercises for large muscle groups with dumbbells and weight sets, resistance bands (therabands) will be used in the training. These exercises are leg press, leg extension, leg curl, squat, seated row, lateral pull down, biceps curl, triceps extension, dumble fly, lateral raises, bench press and abdominal crunch. Exercises will be performed with free weights (dumbbells), resistance bands (therabands) or body weight.

Study groups in NCT06126874
Study groupRoleWhat they receive
Patient education, Pelvic floor muscle training, Aerobic and Resistance exercise trainingsExperimentalPatient Education: Individuals in both study groups will be provided with patient education through verbal and visual presentations. Pelvic Floor Muscle Training (PFMT): In PFMT, voluntary maximal and submaximal contractions for strength and endurance training of pelvic floor muscles will be taught and individuals will continue PFMT as a home exercise program. Aerobic Exercise Training: Aerobic exercise training will be planned 3 days a week, 1 day on the routine clinic day with a treadmill ergometer and 2 days as a home program in the form of brisk walking outside the clinic (e.g. outdoors or in a suitable environment). Resistance Exercise Training: Resisted exercise training will be planned 2 days a week, 1 day in the clinic and 1 day outside the clinic as a home program, and 12 different exercises for large muscle groups with dumbbells and weight sets, resistance bands (therabands) will be used in the training.
Receives: Other: Patient Education; Other: Pelvic Floor Muscle Training; Other: Aerobic Exercise Training; Other: Resistance Exercise Training
Patient education and Pelvic floor muscle trainingActive comparatorPatient Education: Individuals in both study groups will be provided with patient education through verbal and visual presentations. Pelvic Floor Muscle Training (PFMT): In PFMT, voluntary maximal and submaximal contractions for strength and endurance training of pelvic floor muscles will be taught and individuals will continue PFMT as a home exercise program.
Receives: Other: Patient Education; Other: Pelvic Floor Muscle Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF) Score

    The ICIQ-UI Short Form is a questionnaire for evaluating the frequency, severity and impact of urinary incontinence on quality of life (QoL) in men and women in research and clinical practice.

    Measured: Change in severity of incontinence from baseline to the end of the 12th week.

  2. International Index of Erectil Function-15 ( IIEF-15) Score

    The IIEF-15 is a multidimensional scale that can be used to evaluate ED. It has five subdomains: Erectile Function ( items 1,2,3,4,5,15), Orgasmic Function ( items 9,10), Sexual Desire (items 11,12), Intercourse Satisfaction ( items 6,7,8), Overall Satisfaction (items 13,14).

    Measured: Change in severity of erectile function from baseline to the end of the 12th week.

Secondary outcomes (7)

  1. 1-hour Pad Test Score

    1-Hour Pad test is a non-invasive test that is widely used in the evaluation of objective UI severity.

    Measured: Change in severity of incontinence from baseline to the end of the 12th week.

  2. Penile Length

    Penile length will be measured by the therapist with the help of a ruler. This is a non-invasive objective measurement method used in the literature to measure the penile length of individuals after prostatectomy.

    Measured: Change in penile length from baseline to the end of the 12th week.

  3. Peripheral Muscle Strength

    Peripheral muscle strength will be evaluated with a hand-held dynamometer. The handheld dynamometer is a non-invasive and routinely used objective assessment tool preferred in the clinic for strength measurement. Studies have shown that handheld digital dynamometers are useful tools to objectively assess muscle strength before and after intervention and to demonstrate the effectiveness of treatment. In our study, within the scope of peripheral muscle strength measurement, static strength measurements will be performed in shoulder flexion-extension, shoulder abduction-adduction, elbow flexion-extension, hip flexion-extension, knee flexion-extension, and ankle dorsal and plantar flexion.

    Measured: Change in strength of peripheral muscles from baseline to the end of the 12th week.

  4. Functional Exercise Capacity

    Functional exercise capacity of individuals will be evaluated with the 6 Minute Walking Test (6MWT). The 6MWT is a simple and non-invasive test that evaluates the submaximal functional exercise capacity of individuals in 6 minutes on a hard and flat surface, does not require special equipment or advanced training, and has been shown to be reliable and valid in various patient populations in the literature.

    Measured: Change in distance from baseline to the end of the 12th week.

  5. International Consultation On Incontinence- Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) Score

    The ICIQ-MLUTS is a questionnaire for evaluating male lower urinary tract symptoms and impact on quality of life (QoL) in research and clinical practice. It has four subdomains: Voiding Score (2-6 items), Incontinence Score (7-12 items), Frequency of urination during the day (13th item), Frequency of urination during the night (14th item)

    Measured: Change in lower urinary system symptoms scores from baseline to the end of the 12th week.

  6. Depression Anxiety and Stress Scale-21 (DASS-21) Score

    The DASS-21 is a self-report scale designed to measure the negative emotional states of depression, anxiety and stress. It contains 21 questions totally and 7 questions for each symptoms. Depression: dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. (Items 3, 5, 10, 13, 16, 17, 21). Anxiety: autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. (Items 2, 4, 7, 9, 15, 19, 20). Stress: levels of chronic nonspecific arousal, difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient (Items 1, 6, 8, 11, 12, 14, 18).

    Measured: Change in level of depression, anxiety and stress level from baseline to the end of the 12th week.

  7. World Health Organization Quality of Life Brief Version (WHOQOL-BREF) Score

    The World Health Organization Quality of Life Scale-Short Form (WHOQOL-BREF) will be used to question the general quality of life of individuals.The WHOQOL-BREF addresses four quality of life domains: physical health, psychological health, social relationships and environment.

    Measured: Change in quality of life from baseline to the end of the 12th week.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2023
  2. Study start15 Mar 2024 (estimated)
  3. Primary completion15 Jan 2026 (estimated)
  4. Study completion15 Jan 2026 (estimated)

Resources

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
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06126874
Sponsor's protocol ID
KA-23054
Status last verified
Mar 2024
First submitted
7 Nov 2023
Last updated
4 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

    PubMed 1202204

  • Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. doi: 10.1002/nau.20041.

    PubMed 15227649

  • Neijenhuijs KI, Holtmaat K, Aaronson NK, Holzner B, Terwee CB, Cuijpers P, Verdonck-de Leeuw IM. The International Index of Erectile Function (IIEF)-A Systematic Review of Measurement Properties. J Sex Med. 2019 Jul;16(7):1078-1091. doi: 10.1016/j.jsxm.2019.04.010. Epub 2019 May 27.

    PubMed 31147249

  • Jorgensen L, Lose G, Andersen JT. One-hour pad-weighing test for objective assessment of female urinary incontinence. Obstet Gynecol. 1987 Jan;69(1):39-42.

    PubMed 3796918

  • Greenstein A, Dekalo S, Chen J. Penile size in adult men-recommendations for clinical and research measurements. Int J Impot Res. 2020 Mar;32(2):153-158. doi: 10.1038/s41443-019-0157-4. Epub 2019 Jun 6.

    PubMed 31171853

  • Kwon YS, Farber N, Yu JW, Rhee K, Han C, Ney P, Hong JH, Lee P, Gupta N, Kim WJ, Kim IY. Longitudinal recovery patterns of penile length and the underexplored benefit of long-term phosphodiesterase-5 inhibitor use after radical prostatectomy. BMC Urol. 2018 May 9;18(1):37. doi: 10.1186/s12894-018-0341-8.

    PubMed 29739455

  • Chamorro C, Armijo-Olivo S, De la Fuente C, Fuentes J, Javier Chirosa L. Absolute Reliability and Concurrent Validity of Hand Held Dynamometry and Isokinetic Dynamometry in the Hip, Knee and Ankle Joint: Systematic Review and Meta-analysis. Open Med (Wars). 2017 Oct 17;12:359-375. doi: 10.1515/med-2017-0052. eCollection 2017.

    PubMed 29071305

  • Chamorro C, Arancibia M, Trigo B, Arias-Poblete L, Jerez-Mayorga D. Absolute Reliability and Concurrent Validity of Hand-Held Dynamometry in Shoulder Rotator Strength Assessment: Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Sep 3;18(17):9293. doi: 10.3390/ijerph18179293.

    PubMed 34501883

  • Mertoglu O, Ucer O, Ceylan Y, Bozkurt O, Gunlusoy B, Albaz AC, Demir O; Aegean Study Group of Society of Urological Surgery. Reliability and Validity of the Turkish Language Version of the International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms. Int Neurourol J. 2016 Jun;20(2):159-63. doi: 10.5213/inj.1630460.230. Epub 2016 Jun 24.

    PubMed 27377949

  • Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005 Jun;44(Pt 2):227-39. doi: 10.1348/014466505X29657.

    PubMed 16004657

  • Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.

    PubMed 9626712

  • Giannitsi S, Bougiakli M, Bechlioulis A, Kotsia A, Michalis LK, Naka KK. 6-minute walking test: a useful tool in the management of heart failure patients. Ther Adv Cardiovasc Dis. 2019 Jan-Dec;13:1753944719870084. doi: 10.1177/1753944719870084.

    PubMed 31441375

  • Bellet RN, Adams L, Morris NR. The 6-minute walk test in outpatient cardiac rehabilitation: validity, reliability and responsiveness--a systematic review. Physiotherapy. 2012 Dec;98(4):277-86. doi: 10.1016/j.physio.2011.11.003. Epub 2012 May 16.

    PubMed 23122432

  • Rasekaba T, Lee AL, Naughton MT, Williams TJ, Holland AE. The six-minute walk test: a useful metric for the cardiopulmonary patient. Intern Med J. 2009 Aug;39(8):495-501. doi: 10.1111/j.1445-5994.2008.01880.x.

    PubMed 19732197

Questions about this trial

What is this clinical trial studying?

A study testing Patient Education, Pelvic Floor Muscle Training and Aerobic Exercise Training in people with 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 9 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: status not confirmed, as of the sponsor's last update on 4 Mar 2024. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Serap Özgül, PhD (05339390803, serapky@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF) Score (time frame: Change in severity of incontinence from baseline to the end of the 12th week.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06126874, which also lists 14 linked publications.

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 4 Mar 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in