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

NCT04804839 | Completed

• 1 other identifier: KA-20081
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence short form (ICIQ-UIsf (short form))

  Symptom severity and impact of incontinence on life

  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 Outcomes (4)

• Patient Global Impression of Severity question

  In the first evaluation(baseline), during study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week)

• 1 hour pad test

  In the first evaluation(baseline), during study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week)

• King's Health Questionnaire

  In the first evaluation(baseline), during study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week)

• Patient Global Impression of Improvement question

  Post-treatment evaluation (at the end of the eighth week)

Other Outcomes (3)

• International Physical Activity Questionnaire and Likert-type scales.

  During study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week)

• Likert-type scales

  during study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week)

• Exercise diary

  during study (at the end of the fourth week), post-treatment evaluation (at the end of the eighth week)

Study Arms (3)

First research arm (Combined group)

EXPERIMENTAL

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

Other: First research arm

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

EXPERIMENTAL

Only 8-week PFMT (including knack maneuver)

Other: Second research arm

Third research arm (PFMT alone group)

ACTIVE COMPARATOR

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

Other: Third research arm

Interventions

First research arm OTHER

Patients in this group were given 8-week PFMT (including knack maneuver) and lifestyle recommendations for the treatment of urinary incontinence symptoms.

Also known as: Combined group

First research arm (Combined group)

Second research arm OTHER

Patients in this group were given only 8-week PFMT (including knack maneuver) for the treatment of urinary incontinence symptoms.

Also known as: PFMT (including knack maneuver) group

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

Third research arm OTHER

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

Also known as: PFMT alone group

Third research arm (PFMT alone group)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study will be conducted in patients suffering from urinary incontinence after prostatectomy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06080, Turkey (Türkiye)

Location

Related Publications (1)

• Gerlegiz ENA, Akbayrak T, Gursen C, Yazici MS, Bolat NM, Akdogan B, Nakip G, Ozgul S. Lifestyle recommendations and pelvic floor muscle training with Knack maneuver for post-prostatectomy urinary incontinence: a randomized controlled trial. Support Care Cancer. 2025 Jan 31;33(2):132. doi: 10.1007/s00520-025-09197-z.

  PMID: 39888446 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Prostatic Neoplasms; Urinary Incontinence, Stress

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Prostatic Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Serap Kaya, Assoc Prof

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 18, 2021
• Study Start: April 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)