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Benign Prostatic HyperplasiaPPINCT05116592

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

An observational study of Benign Prostatic Hyperplasia and Incontinence, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 90 years, men only
Conditions the study is for
Benign Prostatic Hyperplasia, Incontinence
How many people
330 participants
Where
1 siteTaiwan
Study dates
1 Apr 2020to 2 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 90 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: BPH patients need surgical treatment

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Shiwei Haung, PHD contact

0972655725

y04186@ms1.ylh.gov.tw

Taiwan1 site, 1 recruiting
  • National Taiwan University Hospital

    Chiayi City, 632

    Shiwei Haung, MDPHD, 0972655725, y04186@ms1.ylh.gov.tw

    Recruiting

Other trials in Taiwan

About this study

Official title: 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.

Read the 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
Keywords
transient incontinence,TURP
Medical subject headings
Prostatic Hyperplasia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of postoperative incontinence from baseline to postoperative 6 months asses by iciq-SF

    change of incontinence severity after operation

    Measured: post-op 1 week, 2 weeks, 3 weeks, 1 month, 2 month, 3 month and 6 months

Secondary outcomes (1)
  1. Change of postoperative incontinence from baseline to postoperative 6 months asses by 4-item pad questionnaire

    change of pad usage after operation

    Measured: post-op 1 week, 2 weeks, 3 weeks, 1 month, 2 month, 3 month and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2021
  2. Study start1 Apr 2020
  3. Primary completion2 Jun 2023 (estimated)
  4. Study completion2 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05116592
Sponsor's protocol ID
202003023RINA
Acronym
PPI
Status last verified
Oct 2022
First submitted
13 Oct 2021
Last updated
25 May 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided: need irb approval

Publications

  • Wei JT, Calhoun E, Jacobsen SJ. Urologic diseases in America project: benign prostatic hyperplasia. J Urol. 2005 Apr;173(4):1256-61. doi: 10.1097/01.ju.0000155709.37840.fe.

    PubMed 15758764
  • Malaeb BS, Yu X, McBean AM, Elliott SP. National trends in surgical therapy for benign prostatic hyperplasia in the United States (2000-2008). Urology. 2012 May;79(5):1111-6. doi: 10.1016/j.urology.2011.11.084.

    PubMed 22546389
  • Reich O, Seitz M, Gratzke C, Schlenker B, Walther S, Stief C. [Benign prostatic hyperplasia (BPH) : Surgical therapy options]. Urologe A. 2010 Jan;49(1):113-26. doi: 10.1007/s00120-009-2183-1. German.

    PubMed 20033128
  • Lourenco T, Pickard R, Vale L, Grant A, Fraser C, MacLennan G, N'Dow J; Benign Prostatic Enlargement team. Minimally invasive treatments for benign prostatic enlargement: systematic review of randomised controlled trials. BMJ. 2008 Oct 9;337:a1662. doi: 10.1136/bmj.a1662.

    PubMed 18845591
  • Reich O, Gratzke C, Bachmann A, Seitz M, Schlenker B, Hermanek P, Lack N, Stief CG; Urology Section of the Bavarian Working Group for Quality Assurance. Morbidity, mortality and early outcome of transurethral resection of the prostate: a prospective multicenter evaluation of 10,654 patients. J Urol. 2008 Jul;180(1):246-9. doi: 10.1016/j.juro.2008.03.058. Epub 2008 May 21.

    PubMed 18499179
  • Issa MM. Technological advances in transurethral resection of the prostate: bipolar versus monopolar TURP. J Endourol. 2008 Aug;22(8):1587-95. doi: 10.1089/end.2008.0192.

    PubMed 18721041
  • Liu JF, Liu CX, Tan ZH, Li SX, Li XZ, Chi N. [Transurethral bipolar plasmakinetic enucleation and resection versus transurethral bipolar plasmakinetic resection of the prostate for BPH: a randomized controlled trial on the incidence of postoperative urinary incontinence]. Zhonghua Nan Ke Xue. 2014 Feb;20(2):165-8. Chinese.

    PubMed 24520671
  • Xu N, Chen SH, Xue XY, Wei Y, Zheng QS, Li XD, Huang JB, Cai H, Sun XL, Lin YZ. Older Age and Larger Prostate Volume Are Associated with Stress Urinary Incontinence after Plasmakinetic Enucleation of the Prostate. Biomed Res Int. 2017;2017:6923290. doi: 10.1155/2017/6923290. Epub 2017 Mar 30.

    PubMed 28466017
  • Nam JK, Kim HW, Lee DH, Han JY, Lee JZ, Park SW. Risk Factors for Transient Urinary Incontinence after Holmium Laser Enucleation of the Prostate. World J Mens Health. 2015 Aug;33(2):88-94. doi: 10.5534/wjmh.2015.33.2.88. Epub 2015 Aug 19.

    PubMed 26331125
  • Goode PS, Burgio KL, Johnson TM 2nd, Clay OJ, Roth DL, Markland AD, Burkhardt JH, Issa MM, Lloyd LK. Behavioral therapy with or without biofeedback and pelvic floor electrical stimulation for persistent postprostatectomy incontinence: a randomized controlled trial. JAMA. 2011 Jan 12;305(2):151-9. doi: 10.1001/jama.2010.1972.

    PubMed 21224456

Questions about this trial

What is this clinical trial studying?

An observational study of Benign Prostatic Hyperplasia and Incontinence, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shiwei Haung, PHD (0972655725, y04186@ms1.ylh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05116592, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.

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