Clinical trial NCT06206993: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Prostate Ectomy
Pelvic Floor Disorders
Incontinence, Urinary
Keywords: Prostate Cancer
Pelvic Floor Training
Exercise
Physical Activity
Prostate Ectomy
Incontinence
Cancer
surgery
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: Kieser Training Offenbach / Marko Babovic
name: Kieser Training AG Zürich / Dr. David Aguayo
First posted: 2024-01-16
Enrollment: 99
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Prostate cancer
* Radical prostatectomy (inclusion up to three days after discharge from hospital)
* Willingness to train at the exercise facility for 12 weeks, twice per week and to take part in the scheduled testing
* Sufficient German language skills
* Signed informed consent.

Exclusion Criteria:

* Unstable bone metastases or severe cardiac, neurologic, pulmonary or orthopedic diseases which are contraindications to resistance training
* Severe hemorrhoids, anal fissure, or fistulae which are contraindications to pelvic floor muscle training
* Radical perineal prostatectomy (RPP) due to potential pain when using the A5 machine
* Neurological or muscular diseases ruling out successful pelvic floor muscle training
* Pre-surgical incontinence
* Neobladder
* Pacemaker.

Primary outcomes:
measure: Change from baseline to week 12 of the proportion of continent patients
timeFrame: baseline up to 12 weeks (& 3 month follow-up)
Secondary outcomes:
measure: Change from baseline to week 12 in urinary leakage (cumulative pad weight in the 24 h pad test
timeFrame: baseline up to 12 weeks (& 3 month follow-up)
measure: Change from baseline to week 12 in Health related Quality of life, as measured by the EORTC QLQ-C30
timeFrame: baseline up to 12 weeks (& 3 month follow-up)
measure: Change from baseline to week 12 in incontinence related quality of life (EORTC QLQ PSM module)
timeFrame: baseline up to 12 weeks (& 3 month follow-up)
measure: Change from baseline to week 12 in pain experienced (visual analog scale, VAS)
timeFrame: baseline up to 12 weeks (& 3 month follow-up)
measure: Change from baseline to week 12 in muscle strength (Delfex Sensor System, DSS)
timeFrame: baseline up to 12 weeks (& 3 month follow-up)
measure: Change from baseline to week 12 in body composition (bioelectrical impedance analysis with the Tanita MC780).
timeFrame: baseline up to 12 weeks (& 3 month follow-up)
Other outcomes:
Locations:
city: Offenbach
country: Germany
facility: Kieser Training Offenbach
state: Hessen
Study officials:
References: