PROSTATECTOMYNCT05700487

EFFECT ON QUALITY OF LIFE AFTER PROSTATECTOMY

A study testing PELVIC FLOOR EXERCISES in people with PROSTATECTOMY and URINARY INCONTINENCE, run by TC Erciyes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Aim: This study was conducted to determine the effect of pelvic floor exercises (PTE) on urinary incontinence and quality of life (QOL) after radical prostatectomy (RP). Methods: This randomized controlled, single-blind, experimental study was completed with a total of 33 RP patients, 18 of whom were interventions… Read more about this study

Who is it for?: Ages 40 to 75 years, men onlyHealthy volunteers can take part
Conditions the study is for: PROSTATECTOMY, URINARY INCONTINENCE
What is being tested?: PELVIC FLOOR EXERCISES
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Aug 2019to 29 Apr 2021
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 75 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Being literate,
Having the mental competence to understand the questions,
Radical prostatectomy was performed due to the diagnosis of localized prostate cancer,
Continuing post-operative follow-up,
No incontinence problem before surgery,
Anatomically free of genito-urinary system pathology,
Those who volunteered to participate in the study were recruited.

Who cannot join

With bladder insufficiency (dysfunction),
Individuals with a different type of incontinence problem such as stress incontinence, neurogenic bladder were not included in the study.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

ERciyes University
Kayseri, 38039

Other trials in Turkey (Türkiye)

About this study

Official title: THE EFFECT OF PELVIC FLOOR EXERCISES ON URINARY INCONTINENCE AND QUALITY OF LIFE AFTER PROSTATECTOMY

Aim: This study was conducted to determine the effect of pelvic floor exercises (PTE) on urinary incontinence and quality of life (QOL) after radical prostatectomy (RP).

Methods: This randomized controlled, single-blind, experimental study was completed with a total of 33 RP patients, 18 of whom were interventions, and 15 were controls. The intervention group was given pelvic floor exercises (PTE) training in the preoperative period, regular PTE was performed three times a day for six months in the postoperative period, and the continuity of the exercises was checked by telephone. On the other hand, no intervention was applied to the control group other than routine treatment.

Conditions: PROSTATECTOMY, URINARY INCONTINENCE
Being tested: PELVIC FLOOR EXERCISES
Keywords: Radical Prostatectomy, Pelvic Floor Exercises, Urinary Incontinence, Quality of life
Medical subject headings: Urinary Incontinence

What participants receive

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

PELVIC FLOOR EXERCISESOther
Also called Intervention Group
Regular Pelvic floor exercises was performed three times a day for six months in the postoperative period

Study groups in NCT05700487
Study group	Role	What they receive
Control Group	No intervention	Patients in this group continued their routine medicaltreatmentprogram without any treatment
Intervention Group	Experimental	Pelvic floor exercises (PTE) training in the preoperative period, regular PTE was performed three times a day for 6 months in the postoperative period, and the continuity of the exercises was checked by telephone Receives: Other: PELVIC FLOOR EXERCISES

What is being measured

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

Quality of life Scale(SF-36)
It measures the quality of life of individuals in 7 dimensions. These dimensions are physical function, social function, role limitations due to physical functions, role limitations due to emotional problems, mental health energy/vitality, pain and general perception of health. Instead of giving only a single total score, the scale is for each subscale. gives a total score separately. Subscales evaluate health from 0 to 100. "0 points" denotes the worst health condition, and "100 points" denotes the best health condition.
Measured: The first measurement was made when the patients were included in the study.
Quality of life Scale(SF-36)
It measures the quality of life of individuals in 7 dimensions. These dimensions are physical function, social function, role limitations due to physical functions, role limitations due to emotional problems, mental health energy/vitality, pain and general perception of health. Instead of giving only a single total score, the scale is for each subscale. gives a total score separately. Subscales evaluate health from 0 to 100. "0 points" denotes the worst health condition, and "100 points" denotes the best health condition.
Measured: It was performed at the 1st month follow-ups of the patients.
Quality of life Scale(SF-36)
It measures the quality of life of individuals in 7 dimensions. These dimensions are physical function, social function, role limitations due to physical functions, role limitations due to emotional problems, mental health energy/vitality, pain and general perception of health. Instead of giving only a single total score, the scale is for each subscale. gives a total score separately. Subscales evaluate health from 0 to 100. "0 points" denotes the worst health condition, and "100 points" denotes the best health condition.
Measured: It was performed at the 3st month follow-ups of the patients.
Quality of life Scale(SF-36)
It measures the quality of life of individuals in 7 dimensions. These dimensions are physical function, social function, role limitations due to physical functions, role limitations due to emotional problems, mental health energy/vitality, pain and general perception of health. Instead of giving only a single total score, the scale is for each subscale. gives a total score separately. Subscales evaluate health from 0 to 100. "0 points" denotes the worst health condition, and "100 points" denotes the best health condition.
Measured: It was performed at the 6st month follow-ups of the patients.

Secondary outcomes (4)

The Overactive Bladder (OAB-V8 )
Used to determine clinical incontinence. The OAB- V8 inquiry form determined the severity of the patients' complaints, none (0); very few (1); a little (2); quite a few (3); many (4); and it consists of 8 questions that can be graded as too many (5). The total score ranges from 0 to 40.
Measured: The first measurement was made when the patients were included in the study.
The Overactive Bladder (OAB-V8 )
Used to determine clinical incontinence. The OAB- V8 inquiry form determined the severity of the patients' complaints, none (0); very few (1); a little (2); quite a few (3); many (4); and it consists of 8 questions that can be graded as too many (5). The total score ranges from 0 to 40.
Measured: It was performed at the 1st month follow-ups of the patients.
The Overactive Bladder (OAB-V8 )
Used to determine clinical incontinence. The OAB- V8 inquiry form determined the severity of the patients' complaints, none (0); very few (1); a little (2); quite a few (3); many (4); and it consists of 8 questions that can be graded as too many (5). The total score ranges from 0 to 40.
Measured: It was performed at the 3st month follow-ups of the patients.
The Overactive Bladder (OAB-V8 )
Used to determine clinical incontinence. The OAB- V8 inquiry form determined the severity of the patients' complaints, none (0); very few (1); a little (2); quite a few (3); many (4); and it consists of 8 questions that can be graded as too many (5). The total score ranges from 0 to 40.
Measured: It was performed at the 6st month follow-ups of the patients.

Timeline

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

1 Aug 201929 Apr 2021

First posted26 Jan 2023
Study start1 Aug 2019
Primary completion30 Oct 2020
Study completion29 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for PROSTATECTOMYStudies of the same condition, open and under way.
More trials run by TC Erciyes 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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05700487
Sponsor's protocol ID: PROSTATK
Status last verified: Jan 2023
First submitted: 17 Jan 2023
Last updated: 27 Jan 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Gacci M, Carini M, Simonato A, Imbimbo C, Gontero P, Briganti A, De Cobelli O, Fulcoli V, Martorana G, Nicita G, Mirone V, Carmignani G. Factors predicting continence recovery 1 month after radical prostatectomy: results of a multicenter survey. Int J Urol. 2011 Oct;18(10):700-8. doi: 10.1111/j.1442-2042.2011.02826.x. Epub 2011 Aug 11.
PubMed 21834853
Almallah YZ, Grimsley SJ. A report of a regional service for post-prostatectomy urinary incontinence: a model for best practice? Ther Adv Urol. 2015 Apr;7(2):69-75. doi: 10.1177/1756287214561625.
PubMed 25829950
Venderbos LDF, Aluwini S, Roobol MJ, Bokhorst LP, Oomens EHGM, Bangma CH, Korfage IJ. Long-term follow-up after active surveillance or curative treatment: quality-of-life outcomes of men with low-risk prostate cancer. Qual Life Res. 2017 Jun;26(6):1635-1645. doi: 10.1007/s11136-017-1507-7. Epub 2017 Feb 6.
PubMed 28168601
Santa Mina D, Matthew AG, Hilton WJ, Au D, Awasthi R, Alibhai SM, Clarke H, Ritvo P, Trachtenberg J, Fleshner NE, Finelli A, Wijeysundera D, Aprikian A, Tanguay S, Carli F. Prehabilitation for men undergoing radical prostatectomy: a multi-centre, pilot randomized controlled trial. BMC Surg. 2014 Nov 13;14:89. doi: 10.1186/1471-2482-14-89.
PubMed 25394949
Lee EW, Kobashi KC. Mixed incontinence: what takes precedence in its management? Curr Urol Rep. 2014 Dec;15(12):461. doi: 10.1007/s11934-014-0461-y.
PubMed 25287258

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction
RecruitingPhase 2
A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.
High-risk Localized Prostate Cancer
Active, not recruitingObservational study
Spatial Needle Placement Strategies and Pathological Concordance in Prostate Biopsy: A National Multicenter Retrospective Cohort Study
Prostate Cancer, Prostatic Neoplasms
Active, not recruitingPhase 3
A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
Prostatic Neoplasms
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)

All PROSTATECTOMY trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: THE EFFECT OF PELVIC FLOOR EXERCISES ON URINARY INCONTINENCE AND QUALITY OF LIFE AFTER PROSTATECTOMY
ClinicalTrials.gov ID: NCT05700487
Acronym / sponsor ID: PROSTATK
Conditions: PROSTATECTOMY, URINARY INCONTINENCE
Keywords: Radical Prostatectomy, Pelvic Floor Exercises, Urinary Incontinence, Quality of life
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: TC Erciyes UniversityUniversity, hospital or other
Study start: 1 Aug 2019 (actual)
Primary completion: 30 Oct 2020 (actual)
Study completion: 29 Apr 2021 (actual)
First posted: 26 Jan 2023 (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.

Aim: This study was conducted to determine the effect of pelvic floor exercises (PTE) on urinary incontinence and quality of life (QOL) after radical prostatectomy (RP).

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Control Group	No intervention	–Patients in this group continued their routine medicaltreatmentprogram without any treatment
Intervention Group	Experimental	Other: PELVIC FLOOR EXERCISESPelvic floor exercises (PTE) training in the preoperative period, regular PTE was performed three times a day for 6 months in the postoperative period, and the continuity of the exercises was checked by telephone

Who may qualify

Ages: 40 to 75 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Being literate,
Having the mental competence to understand the questions,
Radical prostatectomy was performed due to the diagnosis of localized prostate cancer,
Continuing post-operative follow-up,
No incontinence problem before surgery,

Key exclusion criteria (2 listed)

With bladder insufficiency (dysfunction),
Individuals with a different type of incontinence problem such as stress incontinence, neurogenic bladder were not included in the study.

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 EXERCISESAlso: Intervention GroupRegular Pelvic floor exercises was performed three times a day for six months in the postoperative period	Other	Intervention Group

Primary outcome

Quality of life Scale(SF-36)
Time frame: The first measurement was made when the patients were included in the study.
It measures the quality of life of individuals in 7 dimensions. These dimensions are physical function, social function, role limitations due to physical functions, role limitations due to emotional problems, mental health energy/vitality, pain and general perception of health. Instead of giving only a single total score, the scale is for each subscale. gives a total score separately. Subscales evaluate health from 0 to 100. "0 points" denotes the worst health condition, and "100 points" denotes the best health condition.
Quality of life Scale(SF-36)
Time frame: It was performed at the 1st month follow-ups of the patients.
It measures the quality of life of individuals in 7 dimensions. These dimensions are physical function, social function, role limitations due to physical functions, role limitations due to emotional problems, mental health energy/vitality, pain and general perception of health. Instead of giving only a single total score, the scale is for each subscale. gives a total score separately. Subscales evaluate health from 0 to 100. "0 points" denotes the worst health condition, and "100 points" denotes the best health condition.
Quality of life Scale(SF-36)
Time frame: It was performed at the 3st month follow-ups of the patients.
It measures the quality of life of individuals in 7 dimensions. These dimensions are physical function, social function, role limitations due to physical functions, role limitations due to emotional problems, mental health energy/vitality, pain and general perception of health. Instead of giving only a single total score, the scale is for each subscale. gives a total score separately. Subscales evaluate health from 0 to 100. "0 points" denotes the worst health condition, and "100 points" denotes the best health condition.
Quality of life Scale(SF-36)
Time frame: It was performed at the 6st month follow-ups of the patients.
It measures the quality of life of individuals in 7 dimensions. These dimensions are physical function, social function, role limitations due to physical functions, role limitations due to emotional problems, mental health energy/vitality, pain and general perception of health. Instead of giving only a single total score, the scale is for each subscale. gives a total score separately. Subscales evaluate health from 0 to 100. "0 points" denotes the worst health condition, and "100 points" denotes the best health condition.

4 secondary outcomes

The Overactive Bladder (OAB-V8 )
Time frame: The first measurement was made when the patients were included in the study.
The Overactive Bladder (OAB-V8 )
Time frame: It was performed at the 1st month follow-ups of the patients.
The Overactive Bladder (OAB-V8 )
Time frame: It was performed at the 3st month follow-ups of the patients.
The Overactive Bladder (OAB-V8 )
Time frame: It was performed at the 6st month follow-ups of the patients.

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 27 Jan 2023.
Background: PubMed 21834853Gacci M, Carini M, Simonato A, Imbimbo C, Gontero P, Briganti A, De Cobelli O, Fulcoli V, Martorana G, Nicita G, Mirone V, Carmignani G. Factors predicting continence recovery 1 month after radical prostatectomy: results of a multicenter survey. Int J Urol. 2011 Oct;18(10):700-8. doi: 10.1111/j.1442-2042.2011.02826.x. Epub 2011 Aug 11.
Background: PubMed 25829950Almallah YZ, Grimsley SJ. A report of a regional service for post-prostatectomy urinary incontinence: a model for best practice? Ther Adv Urol. 2015 Apr;7(2):69-75. doi: 10.1177/1756287214561625.
Background: PubMed 28168601Venderbos LDF, Aluwini S, Roobol MJ, Bokhorst LP, Oomens EHGM, Bangma CH, Korfage IJ. Long-term follow-up after active surveillance or curative treatment: quality-of-life outcomes of men with low-risk prostate cancer. Qual Life Res. 2017 Jun;26(6):1635-1645. doi: 10.1007/s11136-017-1507-7. Epub 2017 Feb 6.
Background: PubMed 25394949Santa Mina D, Matthew AG, Hilton WJ, Au D, Awasthi R, Alibhai SM, Clarke H, Ritvo P, Trachtenberg J, Fleshner NE, Finelli A, Wijeysundera D, Aprikian A, Tanguay S, Carli F. Prehabilitation for men undergoing radical prostatectomy: a multi-centre, pilot randomized controlled trial. BMC Surg. 2014 Nov 13;14:89. doi: 10.1186/1471-2482-14-89.
Background: PubMed 25287258Lee EW, Kobashi KC. Mixed incontinence: what takes precedence in its management? Curr Urol Rep. 2014 Dec;15(12):461. doi: 10.1007/s11934-014-0461-y.

Related trials for PROSTATECTOMY

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Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
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RecruitingPhase 2
A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.
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Spatial Needle Placement Strategies and Pathological Concordance in Prostate Biopsy: A National Multicenter Retrospective Cohort Study
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A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
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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 EXERCISES in people with PROSTATECTOMY and URINARY INCONTINENCE, run by TC Erciyes 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 7 inclusion and 2 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 27 Jan 2023. 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?

Quality of life Scale(SF-36) (time frame: The first measurement was made when the patients were included in the study.). The study lists 4 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 NCT05700487, which also lists 5 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 27 Jan 2023.