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Clinical Trials/CTRI/2024/06/068798
CTRI/2024/06/068798
Not yet recruiting
Not Applicable

"The Effect Of Pelvic Floor Muscle Training On Overactive Bladder Among Individuals with Post Radical Prostatectomy : A Pilot Randomized Controlled Trial"

MGM Institute of Physiotherapy1 site in 1 country20 target enrollmentStarted: June 28, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
20
Locations
1
Primary Endpoint
overactive bladder symptom score

Overview

Brief Summary

AIMS & OBJECTIVES:

AIMS OF STUDY

1.     To evaluate effect of PFMT on overactive bladder among individual Radical Prostatectomy.

OBJECTIVES

1.     To evaluate overactive bladder among individual with post radical prostatectomy.

2.     To study effect of PFMT on overactive bladder among individual post radical prostatectomy.

METHODOLOGY

STUDY DESIGN: Pilot Randomized Controlled Trial.

SAMPLE METHOD: Convenient Method

SAMPLE SIZE: 20 ( 10 in each group)

STUDY DURATION: 6 weeks

STUDY SETTING: Tertiary Care  Hospitals all over the city of Aurangabad.

INCLUSION CRITERIA:

1.     Individuals having overactive bladder post Radical Prostatectomy as identified on the OABSS were included in the study

       EXCLUSION CRITERIA

  1. Individuals having communication difficulties.

  2. Individuals having other Cardio-vascular complications ( unstable angina, uncontrolled hypertension)

  3. Individuals having overactive bladder prior to Radical Prostatectomy.

 MATERIALS USED

1.     Informed consent form-A written, informed and signed consent form.

2.     Data collection sheet

3.     OABSS

PROCEDURE

1.     Study will be initiated after the approval of Institutional Ethical Committee.

2.     After the approval, therapist gains training from a certified pelvic floor rehabilitation specialist for 6 weeks along with behavioral therapy .

3.     Individuals who will be willing to participate in the study will be screened to meet the inclusive and exclusive criteria

4.     Consent will be taken in written form before commencement of the protocol .

5.     Each individual selected for the study will be explained about the purpose of the study

6.     Subject will be assessed for overactive bladder after post radical prostatectomy

7.     The subject will be divided into two group

8.     Group A (experimental group) will be given Pelvic Floor Muscle Training with Behavioral therapy

9.     Group B(controlled group) will be given Behavioural therapy.

10.  The result will be analyse after the 6 weeks of treatment period.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
40.00 Year(s) to 90.00 Year(s) (—)
Sex
Male

Inclusion Criteria

  • Individuals having bladder dysfunction post radical prostatectomy were included in the study.

Exclusion Criteria

  • Individuals having communication difficulties
  • Individuals having cardiovascular complications ( unstable angina, uncontrolled hypertension ) 3.Individuals having bladder dysfunction prior to radical prostatectomy.

Outcomes

Primary Outcomes

overactive bladder symptom score

Time Frame: 20 minutes

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Onkar Bhagwat Raut

MGM Institute of Physiotherapy , N-6,Cidco ,Aurangabad

Study Sites (1)

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