Pelvic Floor Muscles Training After Radical Prostatectomy.
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 300
Summary
- Conditions
- Pelvic Floor Disorders
- Prostatectomy
- Urinary Incontinence
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Parallel crossover studyMasking: Double (Participant, Outcomes Assessor)Masking Description: Stratified randomization was ensured by allocating the subjects using a simple method. One person picked envelopes with group allocation numbers from a computer generated random number table. It should be noted that the main investigator was blinded during the group allocation process. The randomized control trials (RCT) reporting quality has been improved using the CONSORT statement (Consolidated Standards of Reporting Trials).Primary Purpose: Treatment
Participation Requirements
- Age
- Between 40 years and 85 years
- Gender
- Only males
Description
The subject of the study is to assess the impact of physiotherapeutic intervention in the form of pelvic floor muscle training in patients after laparoscopic radical prostatectomy. A randomized control trials will be carried out on a group of about 300 people (men over 40 years of age) before and af...
The subject of the study is to assess the impact of physiotherapeutic intervention in the form of pelvic floor muscle training in patients after laparoscopic radical prostatectomy. A randomized control trials will be carried out on a group of about 300 people (men over 40 years of age) before and after radical prostatectomy. The examined people will be divided into 4 groups and will be assessed before and after surgery: 2 weeks, 6 weeks, 3 months and 6 months. All participants in the study will undergo tests such as: urodynamic, biochemical, MRI, standardized questionnaires regarding the quality of life, physiotherapeutic assessment, histopathological assessment, and cancer progression assessment.
Tracking Information
- NCT #
- NCT04172519
- Collaborators
- Not Provided
- Investigators
- Study Director: Agnieszka Radzimi?ska, PhD Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz Study Chair: Aleksander Goch, Prof. Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz Principal Investigator: Katarzyna Strojek, PhD Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz Principal Investigator: Magdalena Weber-Rajek, PhD Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz Principal Investigator: Agnieszka Str?czy?ska, PhD Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz Principal Investigator: Zuzanna Piekorz, PhD Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz Principal Investigator: Hanna Styczy?ska, PhD Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz Study Director: Piotr Jarzemski, MD, PhD Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz, Principal Investigator: Stanis?aw Wro?ski, MD, PhD The Jan Biziel Hospital in Bydgoszcz, Department of Urology Principal Investigator: Piotr S?upski, MD The Jan Biziel Hospital in Bydgoszcz, Department of Urology Principal Investigator: Beata Pilasrka, RN Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz, Principal Investigator: Marcin Jarzemski, MD The Jan Biziel Hospital in Bydgoszcz, Department of Urology Principal Investigator: Bartosz Brzoszczyk, MD The Jan Biziel Hospital in Bydgoszcz, Department of Urology
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