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Completed

NCT Number: NCT03302169

Trial to Compare Urinary Continence Recovery After Robotic Radical Prostatectomy With or Without Rhabdosphincter Reconstruction.

This is a prospective randomized controlled trail to assess early urinary continence recovery rates after robotic assisted radical prostatectomy when a posterior rhabdosphincter reconstruction is performed or not. A hundred forty-six patients with clinically localized and histological confirmed prostate cancer will be enrolled. Continence recovery is defined in the present study as declared urinary continence (absence of incontinence episodes) in the physician interview as no pad use. Continence rates will be explored also by EPIC, ICIQ-SF, IPSS questionnaires 1, 6 and 12 months after the procedure. The sexual function as the secondary objective will be assessed by SHIM questionnaire.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histological confirmation of prostate cancer
  • Localized or locally advanced prostate cancer
  • Informed consent signed

Exclusion criteria

  • Presence of urinary incontinence prior to the procedure
  • Previous radiation therapy of the prostate or pelvis
  • Presence of any prostatic surgery prior to the procedure
  • Prior medical history of psychiatric diseases or drug addiction
  • Any condition that contraindicates a radical prostatectomy

Treatment and study plan

Radical prostatectomy with posterior rhabdosphincter reconstruction

Procedure

To suture the Denonvilliers fascia and bladder to the median dorsal raphe according to Rocco technique.

Other names: Rocco reconstruction technique, Posterior reconstruction, Rocco Stitch

Radical prostatectomy without posterior rhabdosphincter reconstruction

Procedure

Standard technique with a running suture to perform the urethrovesical anastomosis

Primary outcomes

  1. Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 1st monthNumber of patients using 0-1 PAD/d (EPIC-26 question_5) at 1st month

    Time frame: 1 month after surgery

    Absence of urinary incontinence (number of PADs/d)

  2. Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 6th month

    Time frame: 6 months after surgery

    Absence of urinary incontinence (number of PADs/d)

Secondary outcomes

  1. early urinary recovery quantification in Grams (PAD-test 24h)

    Time frame: one day before catheter removal, 2 weeks before and 1 month before

    PAD-test during the first month after surgery

  2. Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 12th month

    Time frame: 12 months after surgery

    Absence of urinary incontinence (number of PADs/d)

  3. Erectile function

    Time frame: 1, 6 and 12 months

    SHIM assessment

  4. Quality of life I: urinary and bowel function

    Time frame: 1, 6 and 12 months

    EPIC-26 urinary and digestive function

  5. Quality of life II: urinary function

    Time frame: 1, 6 and 12 months

    ICIQ-SF assessment of urinary function

  6. Quality of life III: urinary function

    Time frame: 1, 6 and 12 months

    IPSS assessment of urinary function

  7. Oncological outcome: Biochemical free-recurrence status

    Time frame: 1, 6 and 12 months

    serum PSA assessment. Biochemical free-recurrence status = PSA <0.2

  8. Anatomopathological parameters: Surgical margins

    Time frame: 1 month

    Surgery margins in prostatectomy specimens

  9. Anatomopathological parameters: pTNM classification

    Time frame: 1 month

    Pathological pTNM in prostatectomy specimens

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

Prospective Randomized Controlled Trial to Compare Early Urinary Continence Recovery After Robotic Assisted Radical Prostatectomy With or Without Posterior Rhabdosphincter Reconstruction.

Acronym: RHABDO-PROST

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 5, 2017
Registry last updated
Oct 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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