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Comparison of the Effectiveness of Different Conservative Treatment Protocols in Postprostatectomy Urinary Incontinence

Primary Purpose

Urinary Incontinence, Prostate Cancer, Urinary Incontinence,Stress

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
First research arm
Second research arm
Third research arm
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Knack maneuver, Pelvic floor muscle training, Lifestyle interventions, Kegel exercises, Prostate cancer, Men's health, Pelvic floor exercises

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants older than 18 years of age (with a Mini Mental Test score ≥ 24 for individuals over the ages of 65), who had a complaint of UI after prostatectomy, who did not have any cooperation problems in the evaluations or practices in the study, were included.

Exclusion Criteria:

  • Acute disease state (e.g. urinary tract infection, upper respiratory tract infection, interstitial cystitis, bladder or gastrointestinal bleeding), acute surgical condition (occurring within the first 3 weeks after prostatectomy), neurological disease, or participants with neurogenic bladder, participants with complaints of pure urgency urinary incontinence, presence of preoperative incontinence, who have undergone bladder or other prostate surgeries prior to prostatectomy, who did not give consent to the study and who do not have an informed consent form will not be included.

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

First research arm (Combined group)

Second research arm [PFMT (including knack maneuver) group]

Third research arm (PFMT alone group)

Arm Description

Combined group with 8 weeks of pelvic floor muscle training, knack maneuver and lifestyle recommendations.

Only 8-week PFMT (including knack maneuver)

It is the control group and patients in this group were given alone8-week PFMT (without knack maneuver).

Outcomes

Primary Outcome Measures

International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence short form (ICIQ-UIsf (short form))
Symptom severity and impact of incontinence on life

Secondary Outcome Measures

Patient Global Impression of Severity question
Individual's perception of symptom severity
1 hour pad test
Incontinence severity Pad Test assesses urine loss and leakage volume of the participant
King's Health Questionnaire
Impact of incontinence on quality of life
Patient Global Impression of Improvement question
Individual's perception of improvement

Full Information

First Posted
March 17, 2021
Last Updated
September 6, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04804839
Brief Title
Comparison of the Effectiveness of Different Conservative Treatment Protocols in Postprostatectomy Urinary Incontinence
Official Title
Comparison of the Effectiveness of Different Conservative Treatment Protocols in Individuals With Symptom of Postprostatectomy Urinary Incontinence : a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 26, 2020 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of this study is to reveal the effectiveness of the Knack maneuver and lifestyle recommendations program to be given in addition to the pelvic floor muscle training (PFMT) program, which has been proven to be effective in individuals with urinary incontinence symptoms after prostatectomy. This study is a prospective, controlled, randomized clinical trial. The study includes an 8-week pelvic floor muscle training, Knack maneuver and lifestyle recommendations. In summary, it is stated in the literature that PFMT and lifestyle recommendations are beneficial in the treatment of urinary incontinence (UI). However, although there is evidence of the effectiveness of the Knack maneuver in stress UI in women, there is no evidence of the Knack maneuver in urinary incontinence after prostatectomy. On the other hand, the literature on the effect of lifestyle recommendations after prostatectomy is very limited. Therefore, the aim of this study is to reveal the effectiveness of the Knack maneuver and lifestyle recommendations program, which will be given in addition to the PFMT program, which has been demonstrated in individuals with UI complaints after radical prostatectomy, in a randomized controlled design.
Detailed Description
The main purpose of this study is to reveal the effectiveness of the Knack maneuver and lifestyle recommendations program to be given in addition to the pelvic floor muscle training (PFMT) program, which has been proven to be effective in individuals with urinary incontinence symptoms after prostatectomy. This study is a prospective, controlled, randomized clinical trial. The study includes an 8-week pelvic floor muscle training, Knack maneuver and lifestyle recommendations. It was planned to enroll 72 individuals with urinary incontinence problems after radical prostatectomy in this randomized controlled clinical study. A physical therapist is responsible for all assessments. Participants were included in one of three treatment groups (G1: Pelvic floor muscle training + Knack maneuver + lifestyle recommendations; G2: Pelvic floor muscle training + Knack maneuver G3: Pelvic floor muscle training). In summary, it is stated in the literature that PFMT and lifestyle recommendations are beneficial in the treatment of urinary incontinence (UI). However, although there is evidence of the effectiveness of the Knack maneuver in stress UI in women, there is no evidence of the Knack maneuver in urinary incontinence after prostatectomy. On the other hand, the literature on the effect of lifestyle recommendations after prostatectomy is very limited. Therefore, the aim of this study is to reveal the effectiveness of the Knack maneuver and lifestyle recommendations program, which will be given in addition to the PFMT program, which has been demonstrated in individuals with UI complaints after radical prostatectomy, in a randomized controlled design. With this study, the effectiveness of different programs to be applied to individuals suffering from urinary incontinence after prostatectomy will be determined and compared. It will increase the level of evidence for the treatment of urinary incontinence, a common complaint after prostate cancer surgery. In this direction, it will also contribute to the development of public health.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Prostate Cancer, Urinary Incontinence,Stress, Urinary Incontinence Due to Urethral Sphincter Incompetence
Keywords
Knack maneuver, Pelvic floor muscle training, Lifestyle interventions, Kegel exercises, Prostate cancer, Men's health, Pelvic floor exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
First research arm (Combined group)
Arm Type
Experimental
Arm Description
Combined group with 8 weeks of pelvic floor muscle training, knack maneuver and lifestyle recommendations.
Arm Title
Second research arm [PFMT (including knack maneuver) group]
Arm Type
Experimental
Arm Description
Only 8-week PFMT (including knack maneuver)
Arm Title
Third research arm (PFMT alone group)
Arm Type
Active Comparator
Arm Description
It is the control group and patients in this group were given alone8-week PFMT (without knack maneuver).
Intervention Type
Other
Intervention Name(s)
First research arm
Other Intervention Name(s)
Combined group
Intervention Description
Patients in this group were given 8-week PFMT (including knack maneuver) and lifestyle recommendations for the treatment of urinary incontinence symptoms.
Intervention Type
Other
Intervention Name(s)
Second research arm
Other Intervention Name(s)
PFMT (including knack maneuver) group
Intervention Description
Patients in this group were given only 8-week PFMT (including knack maneuver) for the treatment of urinary incontinence symptoms.
Intervention Type
Other
Intervention Name(s)
Third research arm
Other Intervention Name(s)
PFMT alone group
Intervention Description
It is the control group and patients in this group were given alone8-week PFMT (without knack maneuver).
Primary Outcome Measure Information:
Title
International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence short form (ICIQ-UIsf (short form))
Description
Symptom severity and impact of incontinence on life
Time Frame
In the first evaluation(baseline), during study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week)
Secondary Outcome Measure Information:
Title
Patient Global Impression of Severity question
Description
Individual's perception of symptom severity
Time Frame
In the first evaluation(baseline), during study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week)
Title
1 hour pad test
Description
Incontinence severity Pad Test assesses urine loss and leakage volume of the participant
Time Frame
In the first evaluation(baseline), during study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week)
Title
King's Health Questionnaire
Description
Impact of incontinence on quality of life
Time Frame
In the first evaluation(baseline), during study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week)
Title
Patient Global Impression of Improvement question
Description
Individual's perception of improvement
Time Frame
Post-treatment evaluation (at the end of the eighth week)
Other Pre-specified Outcome Measures:
Title
International Physical Activity Questionnaire and Likert-type scales.
Description
Compliance with lifestyle change recommendations
Time Frame
During study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week)
Title
Likert-type scales
Description
Compliance with smoking, alcohol, tea, caffeine, carbonated beverage, water consumption, bowel order management, exercise and physical activity recommendations will be evaluated separately.
Time Frame
during study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week)
Title
Exercise diary
Description
Adherence to the home exercise program will be assessed.
Time Frame
during study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week)

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
The study will be conducted in patients suffering from urinary incontinence after prostatectomy.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants older than 18 years of age (with a Mini Mental Test score ≥ 24 for individuals over the ages of 65), who had a complaint of UI after prostatectomy, who did not have any cooperation problems in the evaluations or practices in the study, were included. Exclusion Criteria: Acute disease state (e.g. urinary tract infection, upper respiratory tract infection, interstitial cystitis, bladder or gastrointestinal bleeding), acute surgical condition (occurring within the first 3 weeks after prostatectomy), neurological disease, or participants with neurogenic bladder, participants with complaints of pure urgency urinary incontinence, presence of preoperative incontinence, who have undergone bladder or other prostate surgeries prior to prostatectomy, who did not give consent to the study and who do not have an informed consent form will not be included.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serap Kaya, Assoc Prof
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06080
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of the Effectiveness of Different Conservative Treatment Protocols in Postprostatectomy Urinary Incontinence

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