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Genital Diseases, Male

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Placement of a sheet of BioDFence G3 to the neurovascular bundle.

Placement of a sheet of BioDFence® G3 will be applied to the neurovascular bundle on participants undergoing an elective Full Nerve Sparing Radical Prostatectomy for primary treatment of prostate cancer.

BioDFence G3

Vipul R Patel, MD

The purpose of this study is to assess functional outcomes post operatively after the use of BioDFence® G3 during robotic radical prostatectomy.

The purpose of this study is to build on our experience of amniotic membrane use in Robotic Assisted Radical Prostatectomy for prostate cancer, we aim to evaluate clinical outcomes related to the use of BioDFence® G3; a tri-layered amniotic membrane. BioDFence® G3 is regulated by the FDA as a 361 HCT/P for use from head to toe as a tissue barrier for soft tissue repair and as a wound covering.

For the purpose of this study BioDFence® G3 will be placed on the neurovascular bundles by the surgeon during the robotic assisted radical prostatectomy procedure that the participant has elected as their primary treatment for prostate cancer. The potential benefits that will be assessed are an earlier return of potency after surgery as evidenced by The Sexual Health Inventory for Men (SHIM) questionnaire score and self-reported sexual function and secondarily looking at continence outcomes measured by The American Urological Association (AUA) questionnaire form and self-reported urinary function.

All of the patients will be recruited from patients seen in the principal investigator's (PI's) hospital and practice. The offer to participate will be extended to all eligible subjects for the importance of a representative sample.

No women, children or prisoners will be enrolled in this study.

BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy

Treatment Protocol With BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy: A Prospective Open Label Single-Center Study

De-identified information may be utilized in teachings and/or publication as it related to this research.

Outcome measured by the Sexual Health Inventory for Men (SHIM) score and patient reported potency erectile function score.

Outcome measured by the American Urological Association (AUA ) score and patient reported number of urinary sanitation pads used daily.

Integra LifeSciences Corporation

AdventHealth

Dr. Vipul R. Patel

Pelvic Floor Disorders

Genital Neoplasms, Male

Urogenital Neoplasms

Prostatic Diseases

Participants will receive a supervised full body resistance exercise program with 10-12 machines twice weekly.

The resistance training for the experimental group includes an intervention program on the Kieser A5 pelvic floor trainer. The training is a predetermined program of the Kieser Training AG. A standardized instruction protocol and custom settings of the seat minimize training or measurement variations. The exercise on the Kieser A5 pelvic floor muscle trainer is standardized and will take 120 s in total which is based on current training theories.

Participants will receive a supervised full body resistance exercise program with 10-12 machines twice weekly.

Participants in the active comparator group perform the resistance training unit without the pelvic floor biofeedback device A5 and undergo conventional pelvic floor muscle training with a physiotherapist once a week before the resistance training unit starts. Participants are individually informed about the anatomy and function of the pelvic floor muscles and how to correctly contract them. The methodical structure for the movement therapy after prostatectomy suggests that the participants first lay down, then go in the seat, then above the all fours position stand in the upright position tt be treated. Each exercise lasts 3 to 5 min and the session lasts around 20 - 30 min.

In the RECON Study participants of both arms will receive machine-based resistance training. Experimental group will additionally train with Kieser A5 pelvic floor trainer.

Resistance training including the Kieser A5 pelvic floor trainer

In the RECON Study participants of both arms will receive machine-based resistance training. Active Comparator trains without the pelvic floor biofeedback device A5 and undergo conventional pelvic floor muscle training with a physiotherapist once a week before the resistance training unit starts.

Resistance training without pelvic floor biofeedback Kieser A5 pelvic floor trainer

Surgical removal of the prostate (radical prostatectomy) is the most common therapy in prostate cancer patients. However, urinary incontinence often occurs as a side effect. Although this can recede after a few weeks or months, 12 months after prostatectomy 17 - 34 % of the patients are still incontinent. An effective measure to reduce incontinence is pelvic floor muscle or sphincter training. Various methods exist for this, from pelvic floor gymnastics to training with biofeedback devices and electrical stimulation methods.

Kieser Training, a Germany-wide provider of health-oriented resistance training, has a training device for pelvic floor muscle training. It is a biofeedback device that can be used in public training rooms and does not have to be inserted or glued intimately as with comparable methods. The standardized training program and concept, which allows non-invasive training in public space, has not been evaluated yet.

The aim of the RECON study is to investigate whether Kieser resistance training with integrated Kieser pelvic floor muscle training is as effective as (non-inferior to) Kieser resistance training plus conventional pelvic floor muscle exercise to reduce urinary incontinence in prostate cancer patients after radical prostatectomy. The primary endpoint is the proportion of patients with urinary incontinence at the end of a 12-week training phase (using the 24h pad test). The secondary endpoints are changes in urinary leakage, other incontinence symptoms, incontinence-related quality of life, body composition and changes in strength and overall quality of life.

The design is a two-arm randomized controlled trial with 180 prostate cancer patients. After the initial examination patients will be randomized to one of two groups. Patients in both groups will train for about 60 minutes twice a week for twelve weeks and additionally perform daily tension exercises at home. Patients in group A will perform the resistance training unit with the pelvic floor biofeedback device A5 from the Kieser Training AG and patients of group B will perform the resistance training unit without the pelvic floor biofeedback device A5 and undergo conventional pelvic floor muscle training with a physiotherapist once a week before the resistance training unit starts.

The Recon study will be conducted at the Kieser Training Studio in Offenbach, as a cooperation project of the National Center for Tumor Diseases (NCT), Heidelberg University Hospital and the Kieser Training AG with the Kieser Training franchisee (studio owner) as PhD student at the NCT. The Kieser Training AG is not a sponsor and the study is neither financed nor sponsored.

Effects of Kieser Resistance Training Plus Kieser Pelvic Floor Training vs. Kieser Resistance Training Plus Traditional Pelvic Floor Exercise on Urinary Incontinence in Prostate Cancer Patients After Radical Prostatectomy

Major efficacy endpoint (primary endpoint) is the proportion of patients who is continent 12 weeks, with continence defined as no need to wear a pad (1 pads) in the 24 h pad test.

The International Consultation on Incontinence (organized by the International Consultation on Urological Diseases) recommends that criteria for cure/improve/fail of interventions against urinary incontinence should be based on patient perception as well as objective and semi-objective instruments such as validated questionnaires, diaries and pad tests. In the RECON study, the 24 h pad test will be used as an objective measure of incontinence.

Cumulative weight of pads with 24h according to the testing procedure below. The International Consultation on Incontinence (organized by the International Consultation on Urological Diseases) recommends that criteria for cure/improve/fail of interventions against urinary incontinence should be based on patient perception as well as objective and semi-objective instruments such as validated questionnaires, diaries and pad tests. In the RECON study, the 24 h pad test will be used as an objective measure of incontinence.

Quality of life will be assessed with the validated 30-item self-assessment questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30, version 3.0). It comprises five multi-item functional scales (physical, role, emotional, cognitive, and social function), three multi-item symptom scales (fatigue, pain, nausea/vomiting), and six single items assessing further symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea) and financial difficulties. Scores range from 0 to 100. A higher score for the functional scales and global health status denote a better level of functioning, whereas a high score for symptom/single-item scale indicate a higher level of symptomatology/problems. Change = (Week 24 Score - Baseline Score)

The prostate cancer module EORTC QLQ PR25 (25-item) is meant for use among patients with prostate cancer varying in disease stage and treatment modality (i.e. surgery, chemotherapy, radiotherapy, etc.) in addition to the QLQ-C30. This instrument contains, among other things, three symptom scales for measuring "bladder symptoms", "intestinal symptoms" and the burden of "incontinence aids". These scales have a value range of 0 to 100 points, with a higher value indicating a higher symptom load.

The visual analogue scale (VAS) entered the realm of pain research in the 1980s, demonstrating a greater sensitivity to increments or decrements in pain than other instruments. It is a subjective pain measurement ranging from "no pain" to "unbearable pain" as two ends of a 10 cm line. The patient marks his subjective sensation on the line. The specified value is then quantified by the investigator. The Reliability of the VAS for acute pain measurement appears to be high

Isometric strength tests will be performed on three resistance training machines by means of a Kieser force sensor. The force sensor is a mobile measuring instrument. During movement, the staking rod of the machine is only moved until the force sensor hits the base plate of the upper weight block from below. By applying additional force, a strain gauge inside the sensor is subjected to elastic bending.

The bioelectrical impedance analyzer Tanita MC780MA will be used for the assessment body composition. A weak electric current is conducted through the body through contacts on hands and feet. Different components of the body act as a resistor (impedance). The measured outcome is the phase angle.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy	NCT05363644	Prostate Cancer Prostatectomy Erectile Dysfun... Incontinence, U...	BioDFence G3	40 Years - 70 Years	AdventHealth
BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy	NCT05363644	Prostate Cancer Prostatectomy Erectile Dysfun... Incontinence, U...	BioDFence G3	40 Years - 70 Years	AdventHealth
Effects of Kieser Resistance Training Plus Kieser Pelvic Floor Training vs. Kieser Resistance Training Plus Traditional Pelvic Floor Exercise on Urinary Incontinence in Prostate Cancer Patients After Radical Prostatectomy	NCT06206993	Prostate Cancer Prostate Ectomy Pelvic Floor Di... Incontinence, U...	Resistance trai... Resistance trai...	18 Years -	University Hospital Heidelberg

Spots Global Cancer Trial Database for incontinence, urinary