Prostate CancerRECONNCT06206993
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
A study testing Resistance training including the Kieser A5 pelvic floor trainer and Resistance training without pelvic floor biofeedback Kieser A5 pelvic floor trainer in people with Prostate Cancer and Prostate Ectomy, run by University Hospital Heidelberg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Ectomy, Pelvic Floor Disorders
- What is being tested?
- Resistance training including the Kieser A5 pelvic floor trainer and Resistance training without pelvic floor biofeedback Kieser A5 pelvic floor trainer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2019to 1 Apr 2024
- Phase
- Interventional
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Being tested
- Resistance training including the Kieser A5 pelvic floor trainer, Resistance training without pelvic floor biofeedback Kieser A5 pelvic floor trainer
- Keywords
- Prostate Cancer, Pelvic Floor Training, Exercise, Physical Activity, Prostate Ectomy, Incontinence, Cancer, surgery
- Medical subject headings
- Prostatic Neoplasms, Pelvic Floor Disorders, Urinary Incontinence, Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance training including the Kieser A5 pelvic floor trainerBehavioural
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 without pelvic floor biofeedback Kieser A5 pelvic floor trainerBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Resistance training on the Kieser A5 pelvic floor trainer | Experimental | 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. Receives: Behavioral: Resistance training including the Kieser A5 pelvic floor trainer |
| Resistance training without pelvic floor biofeedback Kieser A5 pelvic floor trainer | Active comparator | 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. Receives: Behavioral: Resistance training without pelvic floor biofeedback Kieser A5 pelvic floor trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to week 12 of the proportion of continent patients
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.
Measured: baseline up to 12 weeks (& 3 month follow-up)
Secondary outcomes (6)
Change from baseline to week 12 in urinary leakage (cumulative pad weight in the 24 h pad test
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.
Measured: baseline up to 12 weeks (& 3 month follow-up)
Change from baseline to week 12 in Health related Quality of life, as measured by the EORTC QLQ-C30
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)
Measured: baseline up to 12 weeks (& 3 month follow-up)
Change from baseline to week 12 in incontinence related quality of life (EORTC QLQ PSM module)
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.
Measured: baseline up to 12 weeks (& 3 month follow-up)
Change from baseline to week 12 in pain experienced (visual analog scale, VAS)
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
Measured: baseline up to 12 weeks (& 3 month follow-up)
Change from baseline to week 12 in muscle strength (Delfex Sensor System, DSS)
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.
Measured: baseline up to 12 weeks (& 3 month follow-up)
Change from baseline to week 12 in body composition (bioelectrical impedance analysis with the Tanita MC780).
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.
Measured: baseline up to 12 weeks (& 3 month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start1 Sep 2019
- Primary completion13 Sep 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Kieser Training Offenbach / Marko Babovic, Kieser Training AG Zürich / Dr. David Aguayo
- Responsible party
- Principal investigator, Joachim Wiskemann, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206993
- Sponsor's protocol ID
- S-458/2019
- Acronym
- RECON
- Status last verified
- May 2024
- First submitted
- 15 Dec 2023
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Babovic M, Aguayo D, Wiskemann J. Non-invasive biofeedback-assisted vs. conventional pelvic floor muscle training combined with high-effort resistance training for urinary incontinence after radical prostatectomy: a randomized controlled trial. BMC Urol. 2026 Sep 14;26(1):219. doi: 10.1186/s12894-026-02333-9.
PubMed 42754866
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06206993
- Acronym / sponsor ID
- RECON / S-458/2019
- Keywords
- Prostate Cancer, Pelvic Floor Training, Exercise, Physical Activity, Prostate Ectomy, Incontinence, Cancer, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- Kieser Training Offenbach / Marko Babovic, Kieser Training AG Zürich / Dr. David Aguayo
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance training on the Kieser A5 pelvic floor trainer | Experimental | Behavioral: Resistance training including the Kieser A5 pelvic floor trainerParticipants 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. |
| Resistance training without pelvic floor biofeedback Kieser A5 pelvic floor trainer | Active comparator | Behavioral: Resistance training without pelvic floor biofeedback Kieser A5 pelvic floor trainerParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance training including the Kieser A5 pelvic floor trainerIn the RECON Study participants of both arms will receive machine-based resistance training. Experimental group will additionally train with Kieser A5 pelvic floor trainer. | Behavioural | Resistance training on the Kieser A5 pelvic floor trainer |
| Resistance training without pelvic floor biofeedback Kieser A5 pelvic floor trainerIn 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. | Behavioural | Resistance training without pelvic floor biofeedback Kieser A5 pelvic floor trainer |
Primary outcome
Change from baseline to week 12 of the proportion of continent patients
Time frame: baseline up to 12 weeks (& 3 month follow-up)
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.
6 secondary outcomes
Change from baseline to week 12 in urinary leakage (cumulative pad weight in the 24 h pad test
Time frame: baseline up to 12 weeks (& 3 month follow-up)
Change from baseline to week 12 in Health related Quality of life, as measured by the EORTC QLQ-C30
Time frame: baseline up to 12 weeks (& 3 month follow-up)
Change from baseline to week 12 in incontinence related quality of life (EORTC QLQ PSM module)
Time frame: baseline up to 12 weeks (& 3 month follow-up)
Change from baseline to week 12 in pain experienced (visual analog scale, VAS)
Time frame: baseline up to 12 weeks (& 3 month follow-up)
Change from baseline to week 12 in muscle strength (Delfex Sensor System, DSS)
Time frame: baseline up to 12 weeks (& 3 month follow-up)
Change from baseline to week 12 in body composition (bioelectrical impedance analysis with the Tanita MC780).
Time frame: baseline up to 12 weeks (& 3 month follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Derived from this study: PubMed 42754866Babovic M, Aguayo D, Wiskemann J. Non-invasive biofeedback-assisted vs. conventional pelvic floor muscle training combined with high-effort resistance training for urinary incontinence after radical prostatectomy: a randomized controlled trial. BMC Urol. 2026 Sep 14;26(1):219. doi: 10.1186/s12894-026-02333-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training including the Kieser A5 pelvic floor trainer and Resistance training without pelvic floor biofeedback Kieser A5 pelvic floor trainer in people with Prostate Cancer and Prostate Ectomy, run by University Hospital Heidelberg at 1 site in Germany.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 13 May 2024. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to week 12 of the proportion of continent patients (time frame: baseline up to 12 weeks (& 3 month follow-up)). 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 NCT06206993, which also lists 1 linked publication.
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 13 May 2024.