The Efficacy of Pre-operative Educational Pelvic Floor Intervention on Urinary Continence

NCT03714984 | Completed

• 1 other identifier: IEO 818
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Prostate cancer is the most common type of cancer between male population and urinary incontinence (UI) is the most common of long-term sequelae. Nowadays, robotic prostatectomy became the surgery standard but there is still discrepant results regards the incidence of UI and there is a lack of studies about the use of pelvic floor rehabilitation in this population. Our study aims to assesses the efficacy of preoperative educational method in urinary incontinence after robotic prostatectomy.

Conditions

Prostatectomy; Pelvic Floor Disorders

Keywords

Prostatectomy; Pelvic Floor Disorders; Robotic Surgical Procedures; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in self-reported urinary continence

  Continence (completely dry patient) will be defined as the sum of no urinary leakage reported by the patient in his bladder diary

  1,3,6 months and 1 year after surgery

Secondary Outcomes (5)

• The degree of urinary incontinence.

  1,3,6 months and 1 year after surgery

• Quality of life instrument

  1,3,6 months and 1 year after surgery

• Assesment of the post traumatic distress using the Impact of event Scale (IES).

  1,3,6 months and 1 year after surgery

• Assesment of the individual resilience with the resilience scale for adults (RSA).

  1,3,6 months and 1 year after surgery

• Assesment of the urinary status with the International Consultation on Incontinence (ICIQ) Questionnaire.

  1,3,6 months and 1 year after surgery

Study Arms (2)

Pre operative exercise

EXPERIMENTAL

The educational pelvic floor intervention group will receive one months before surgery a physiotherapy visit were will be explain to patients and care giver the pelvic floor anatomy and biomechanics and how perform the exercises to be follow at home focusing on pelvic muscles awareness and contraction. Patients and care giver will receive a daily exercise diary to fill at home and will be advised to follow the exercise program.

Other: Pre operative exercise

Control group

ACTIVE COMPARATOR

The control group will be just informed about the study protocol and will not receive any pre-operative intervention.

Other: Control Group

Interventions

Pre operative exercise OTHER

After randomization participants will be allocated in two groups. The educational pelvic floor intervention group will receive two months before surgery a physiotherapy visit were will be explain to patients and care giver the pelvic floor anatomy and biomechanics and how perform the exercises to be follow at home focusing on pelvic muscles awareness and contraction.

Pre operative exercise

Control Group OTHER

The control group will be just informed about the study protocol and will not receive any pre-operative intervention.

Control group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form
• Age \>= 40 \<= 70 years old
• Body mass Index \<= 27
• Indication of robotic prostate surgery
• Tumor with clinical stage T1 and T2.
• Extracapsular Extension Score \<= 3, measured with magnetic resonance before surgery.

You may not qualify if:

• Pathologic T3 tumor with radiotherapy indication
• Previous prostate surgery
• Previous urinary incontinence.
• Metabolic disorder
• Central or peripheral neurologic disorders
• Inability to understand informed consent or to carry out the rehabilitation protocol autonomously.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

Istituto Europeo di Oncologia

Milan, Lombardy, 20141, Italy

Location

Related Publications (4)

• Fossati N, Di Trapani E, Gandaglia G, Dell'Oglio P, Umari P, Buffi NM, Guazzoni G, Mottrie A, Gaboardi F, Montorsi F, Briganti A, Suardi N. Assessing the Impact of Surgeon Experience on Urinary Continence Recovery After Robot-Assisted Radical Prostatectomy: Results of Four High-Volume Surgeons. J Endourol. 2017 Sep;31(9):872-877. doi: 10.1089/end.2017.0085. Epub 2017 Jul 21.

  PMID: 28732186 BACKGROUND

• Centemero A, Rigatti L, Giraudo D, Lazzeri M, Lughezzani G, Zugna D, Montorsi F, Rigatti P, Guazzoni G. Preoperative pelvic floor muscle exercise for early continence after radical prostatectomy: a randomised controlled study. Eur Urol. 2010 Jun;57(6):1039-43. doi: 10.1016/j.eururo.2010.02.028. Epub 2010 Mar 1.

  PMID: 20227168 BACKGROUND

• Moore KN, Valiquette L, Chetner MP, Byrniak S, Herbison GP. Return to continence after radical retropubic prostatectomy: a randomized trial of verbal and written instructions versus therapist-directed pelvic floor muscle therapy. Urology. 2008 Dec;72(6):1280-6. doi: 10.1016/j.urology.2007.12.034. Epub 2008 Apr 2.

  PMID: 18384853 BACKGROUND

• Burgio KL, Goode PS, Urban DA, Umlauf MG, Locher JL, Bueschen A, Redden DT. Preoperative biofeedback assisted behavioral training to decrease post-prostatectomy incontinence: a randomized, controlled trial. J Urol. 2006 Jan;175(1):196-201; discussion 201. doi: 10.1016/S0022-5347(05)00047-9.

  PMID: 16406909 BACKGROUND

MeSH Terms

Conditions

Pelvic Floor Disorders

Interventions

Preoperative Exercise; Control Groups

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Luiz Felipe Nevola Teixeira, PT

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Superiority trial with 1:1 allocation ratio, randomized with two-arm parallel group

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 22, 2018
• Study Start: October 15, 2018
• Primary Completion: December 4, 2019
• Study Completion: December 4, 2023
• Last Updated: April 17, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)