The Risk Factor and Outcome of Transient Incontinence After Prostate Enucleation Surgery (PPI)

May 23, 2023 updated by: National Taiwan University Hospital

Post Prostatectomy Incontinence After Enucleation Surgery

Lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH) are the most common urological problem among men. monopolar transurethral resection of the prostate (TURP), in which the enlarged prostate tissue is resected piece by piece using a monopolar electrode, has been the gold standard since the 1970s. It can substantially improve the maximal flow rate (Qmax), urinary symptoms (International Prostate Symptom Score, IPSS), and health-related quality of life (QOL), with long-term efficacy compared to medications or other minimally invasive treatments.4 5 However, monopolar TURP is a risky procedure because of the likelihood of severe complications such as massive bleeding or transurethral resection (TUR) syndrome.6 Therefore, it is of paramount importance to develop minimally invasive surgical techniques with outcomes similar to those of monopolar TURP, but with fewer side effects. Therefore, new energy system with different surgical methods developed after 2000s. Among all, Enucleation methods was proved to have better Qmax and IPSS after surgery than vaporization and resection methods. However, the risk of short-term transient incontinence was higher in enucleation than in resection methods.

Hence modified methods such as upside down, apical preservation methods, defining the limits of dissection proximal to external sphincter prior to enucleation of prostate were developed in order to reduce transient incontinence. Besides, the necessity of preoperative urodynamic study and biofeedback training, investigate the risk factors of transient incontinence are important issues. The study using prospective cohort design recruit 300 BPH patient receiving enucleation methods. To investigate the risk factors of transient incontinence and establish model to predict the incontinence. Besides we will evaluate different surgical methods and treatment methods to improve transient incontinence and the long-term results of different enucleation methods.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH) are the most common urological problem among men. Approximately one-third of men over the age of 50 are affected by this problem. Surgical intervention is the most effective treatment for BPH, with around 100,000 procedures carried out annually in the United States. Of all surgical treatments, monopolar transurethral resection of the prostate (TURP), in which the enlarged prostate tissue is resected piece by piece using a monopolar electrode, has been the gold standard since the 1970s. It can substantially improve the maximal flow rate (Qmax), urinary symptoms (International Prostate Symptom Score, IPSS), and health-related quality of life (QOL), with long-term efficacy compared to medications or other minimally invasive treatments. However, monopolar TURP is a risky procedure because of the likelihood of severe complications such as massive bleeding or transurethral resection (TUR) syndrome. Therefore, it is of paramount importance to develop minimally invasive surgical techniques with outcomes similar to those of monopolar TURP, but with fewer side effects.

Since the 2000s, new energy systems for BPH surgical interventions quickly became popular, including systems that use bipolar energy and various laser systems, such as the holmium laser, potassium-titanyl-phosphate (KTP) laser, thulium laser, and diode laser. The trend in BPH surgical therapy has shifted from monopolar TURP to laser therapies and bipolar TURP over the past 10 years. Bipolar energy can be used to incise, resect, and vaporize prostate tissue using different electrodes. Holmium and thulium laser beams are mainly absorbed by water and act as incisional lasers. The KTP laser is selectively absorbed by hemoglobin and debulks prostate tissue through vaporization. The diode laser is absorbed by water and hemoglobin can therefore vaporize and incise prostate tissue. These new methods all use normal saline instead of distilled water to avoid hyponatremia. They can be further divided into three types according to their treatment principles: resection methods (resection of prostate tissue piece by piece), vaporization methods (vaporization of excessive prostate tissue), and enucleation methods (peeling the enlarged prostate from the prostate capsule).

Enucleation methods was proved to have better Qmax and IPSS after surgery than vaporization and resection methods. In a network meta-analysis, enucleation methods, including bipolar enucleation of prostate , holmium, thulium, and diode laser enucleation of prostate, yielded greater Qmax values at 6-12-months after surgery than did the resection and vaporization methods, and the difference could still be observed at 24-36 months after treatment. The advantages of the enucleation over vaporization methods were mainly observed in large prostates. Enucleation methods also achieved better IPSS than resection and vaporization methods, although the difference was not statistically significant. The new methods were generally safer than monopolar TURP. They were less likely to require patient transfusion, cause blood clot tamponade, lead to postoperative hemoglobin decline, or cause TUR syndrome.

However, the risk of short-term transient incontinence was higher in enucleation than in resection methods. Compared with resection methods, enucleation methods had more events of short-term transient urinary incontinence than resection methods. (odds ratio (OR)=1.91, 95% Confidence interval (CI); 1.35 to 2.71) Liu et al compared bipolar enucleation with bipolar TURP and found that after Foley removal, the incontinence rate was higher in enucleation than in resection at 24 hours (35.6 % vs 18.9%, p<0.01) and one week (20% vs 7.8%, p<0.05).28 There was no difference after two weeks postoperatively (3.3% vs 2.2 % at 2 weeks).

Xu et al retrospectively reviewed 1288 patient receiving bipolar enucleation and found that older age and large prostate volume were associated with postoperative stress urinary incontinence. Besides, operation time and blood loss were also reported as risk factors.

Hence many authors used modified methods such as upside down, apical preservation methods, defining the limits of dissection proximal to external sphincter prior to enucleation, in order to reduce postoperative urinary incontinence. Besides pelvic floor exercise was demonstrated to shorten the periods of stress urinary incontinence. However, the role of pelvic floor exercise in enucleation methods in BPH patients are unclear. These questions need further investigations.

6、study aim： To investigate the risk factors of transient incontinence and establish model to predict the incontinence. Besides we will evaluate different surgical methods and treatment methods to improve transient incontinence and the long-term results of different enucleation methods.

7、material and methods： I. study design: prospective cohort study II. . We plan to invite 300 patients whom received enucleation (laser or bipolar) surgery for BPH during 2020 march to 2022 march in National Taiwan University Hospital yun-lin branch to participate this study. We adopted usual care and collect patient's preoperative, intraoperative and postoperative data. The preoperative data include age, comorbidities, medication history, urodynamic parameters and urinary questionnaire. Intraoperative data include operative methods, operative time and surgical complications. Postoperative parameters include urinary questionnaire such as International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF), 4-time use pad questionnaire, IPSS, 7-item Overactive Bladder Symptom Score (OABSS) and urodynamic parameters.

III. Outcome measure

  1. Maximum urinary flow rate (Qmax) Prostate volume (TRUSP) , post-voiding residual urine (PVR ) at baseline, 3, 6, 12, and 24-month follow-up visits, pressure-flow study at baseline if indicated.
  2. If incontinence and using pad, then biofeedback, ICIQ-SF, 4-item use pad questionnaire every week until incontinence cured. and different type of urinary incontinence such as stress UI, urge UI, total incontinence, mixed incontinence et al
  3. IPSS, OABSS instruments, flow, TRUSP and PVR will be scored per instructions for each instrument collected at baseline and at baseline, 3, 6, 12, and 24-month follow-up visits
  4. Pre-operative parameters: Age, BMI, comorbidities (DM, Hypertension, heart disease, neurologic disease), anal tone (DRESS), PSA
  5. Op parameters: op methods (original en blcok or anterioposterio dissection, preserve 11-1 ocolock) enucleation and morcellation time， catheterization duration,
  6. Complication: using modified clavien-dindo classification grade 1-4

Study Type

Observational

Enrollment (Estimated)

330

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Chiayi City, Taiwan, 632
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

BPH patients need surgical treatment

Description

Inclusion criteria:

  • Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction
  • Clinical investigator has documented in the subject's medical record that in his/her judgment the subject is a surgical candidate
  • Subject is 40 to 90 years of age
  • Subject has an IPSS score greater than or equal to 12 measured at the baseline visit
  • Subject has medical record documentation of a maximum urinary flow rate (Qmax) less than 15ml/s
  • Subject is classified as American Society of Anesthesiologists (ASA) I, II or III

Exclusion criteria:

  • Subject has a life expectancy of less than 2 years
  • Subject has an active infection (eg, urinary tract infection or prostatitis)
  • Subject has a diagnosis of, or has received treatment for, chronic prostatitis or -chronic pelvic pain syndrome (eg, non-bacterial chronic prostatitis)
  • Subject has been diagnosed with a urethral stricture or bladder neck contracture
  • Subject has history of lower urinary tract surgery (eg, TURP, laser, urinary diversion, artificial urinary sphincter, penile prosthesis)
  • Subject has diagnosis of stress urinary incontinence that requires treatment or daily pad/device use
  • Subject has diagnosis of prostate cancer and receive cancer treatment
  • Subject has a history of carcinoma in situ (CIS), Ta Grade 2, Ta Grade 3 or any T1 stage bladder cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of postoperative incontinence from baseline to postoperative 6 months asses by iciq-SF
Time Frame: post-op 1 week, 2 weeks, 3 weeks, 1 month, 2 month, 3 month and 6 months
change of incontinence severity after operation
post-op 1 week, 2 weeks, 3 weeks, 1 month, 2 month, 3 month and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of postoperative incontinence from baseline to postoperative 6 months asses by 4-item pad questionnaire
Time Frame: post-op 1 week, 2 weeks, 3 weeks, 1 month, 2 month, 3 month and 6 months
change of pad usage after operation
post-op 1 week, 2 weeks, 3 weeks, 1 month, 2 month, 3 month and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Shiwei Haung, MDPHD, National Taiwan University Hospital, Yun-Lin branch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Estimated)

June 2, 2023

Study Completion (Estimated)

June 2, 2024

Study Registration Dates

First Submitted

October 13, 2021

First Submitted That Met QC Criteria

October 31, 2021

First Posted (Actual)

November 11, 2021

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202003023RINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

need irb approval

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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