Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04043637
Other study ID # 19/24
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 23, 2012
Est. completion date April 10, 2019

Study information

Verified date July 2019
Source Consorci Sanitari Integral
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study describes how to perform a correct prostatic apex and membranous urethra in order to preserve all anatomical elements that are necessary to achieve a very fast urinary continence after open/laparoscopic/robotic radical prostatectomy, avoiding positive surgical margins at this level.


Description:

This study describes a simple technical variation, aimed at the sparing of the muscle systems and neurovascular bundles in order to achieve high rates of urinary continence in the early postoperative period ( the first two months after surgery) in prostate cancer patients undergoing radical prostatectomy.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date April 10, 2019
Est. primary completion date December 3, 2018
Accepts healthy volunteers No
Gender Male
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria:

- Age between 40 and 75 years

- A Body Mass Index lower than 35 Hg/m2

- Patients with organ-confined prostate cancer

- Signed informed consent

Exclusion Criteria:

- Contraindications for Laparoscopy

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Consorci Sanitari Integral

Outcome

Type Measure Description Time frame Safety issue
Primary change in the proportion of patients with of urinary incontinence Assessment of the proportion of patients with urinary incontinence after laparoscopic radical prostatectomy The follow-up was at 2 weeks, 4 weeks and 8 weeks after removal of the urethral catheter (one week after surgery), and, thereafter, once a month over the first year after surgery
Secondary change in the proportion of patients with recovery of the erectile function assessment of the recovery of the erectile function after surgery every month during the first year after surgery
Secondary number of patients with overall positive surgical margins postoperative assessment of positive surgical margins immediate postoperative period
Secondary biochemical recurrence rate until the completion of the study, with a mean follow-up of 72 months
See also
  Status Clinical Trial Phase
Recruiting NCT05534412 - A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Incontinence N/A
Recruiting NCT05515198 - Improving Care for Women With Urinary Incontinence (EMPOWER) N/A
Completed NCT04071301 - Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence N/A
Completed NCT03623880 - Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders N/A
Recruiting NCT05880862 - Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls Early Phase 1
Recruiting NCT04159467 - Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet N/A
Completed NCT05485922 - Performance of a Single-use Intermittent Micro-hole Zone Catheter N/A
Completed NCT06268782 - The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women N/A
Not yet recruiting NCT03027986 - Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy N/A
Recruiting NCT02490917 - ACT™ Balloons Versus Artificial Urinary Sphincter (AMS800™) for the Treatment of Female Stress Urinary Incontinence N/A
Enrolling by invitation NCT02529371 - Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients N/A
Enrolling by invitation NCT02530372 - Feasibility of the UriCap-F for Urine Collection in Hospitalized Women N/A
Completed NCT02600676 - Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis N/A
Completed NCT02549729 - Effect of the Pelvic Floor Training in Postmenopausal Women With or Without Hormonal Therapy N/A
Completed NCT02338726 - Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study N/A
Completed NCT02368262 - Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy N/A
Completed NCT02239796 - Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence N/A
Completed NCT01942681 - Female Patients With Signs of uRgE and Stress Urinary Incontinence Study of Propiverine Hydrochloride N/A
Recruiting NCT01804153 - Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO) Phase 1/Phase 2
Completed NCT01520948 - Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease Phase 3