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

NCT ID: NCT04804839

Last Updated: 2024-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-03-01

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.

Conditions

Urinary Incontinence; Prostate Cancer; Urinary Incontinence,Stress; Urinary Incontinence Due to Urethral Sphincter Incompetence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

First research arm (Combined group)

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

Group Type: EXPERIMENTAL

First research arm

Intervention Type: OTHER

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

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

Only 8-week PFMT (including knack maneuver)

Group Type: EXPERIMENTAL

Second research arm

Intervention Type: OTHER

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

Third research arm (PFMT alone group)

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

Group Type: ACTIVE_COMPARATOR

Third research arm

Intervention Type: OTHER

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

Interventions

First research arm

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

Second research arm

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

Intervention Type: OTHER

Third research arm

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

Intervention Type: OTHER

Other Intervention Names

Combined group; PFMT (including knack maneuver) group; PFMT alone group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

SERAP ÖZGÜL

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Serap Kaya, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

Hacettepe University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 39888446 (View on PubMed)

Other Identifiers

KA-20081

Identifier Type: -

Identifier Source: org_study_id