ContinencePhase 2/3NCT03864939
Application of Dried Human Amnion Graft to Improve Postprostatectomy Incontinence and Potency
A Phase 2/3 study testing dHAM and No dHAM in people with Continence and Potency, run by German Centre for Assessment and Evaluation of Innovative Techniques in Medicine at 1 site in Germany.
Trial summary
The investigators present a randomized trial of patients undergoing placement of dehydrated human amnion membrane (dHAM) around the neurovascular bundle (NVB) and vesicourethral anastomosis (VUA) during radical retropubic prostatectomy (RRP) in a tertiary center in Germany. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Continence, Potency, Complication
- What is being tested?
- dHAM and No dHAM
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 328 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2019to 1 Apr 2025
- Phase
- Phase 2/3
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with localized prostate cancer
- indication for radical prostatectomy
- no other treatment of prostate cancer
- availability to informed consent
Who cannot join
- preoperative incontinence (24hrs pad-test)
- preoperative erectile dysfunction (IIEF-5 < 20)
- metastasized or locally advanced prostate cancer in preoperative assessment
- previous radiation of pelvis
- previous prostate cancer therapy
- psychiatric disease
- participation at another study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Urology, Lukas Hospital
Neuss, 40464
Dimitri Barski, PhD, 004921318882401, dbarski@lukasneuss.de
About this study
Official title: Randomized Pilot Study to Improve Postprostatectomy Incontinence and Potency by Application of Dried Human Amnion Graft
The investigators present a randomized trial of patients undergoing placement of dehydrated human amnion membrane (dHAM) around the neurovascular bundle (NVB) and vesicourethral anastomosis (VUA) during radical retropubic prostatectomy (RRP) in a tertiary center in Germany.
Read the detailed description
Patients suffer under incontinence and impotence after RRP, improving techniques and studies are missing. The human amniotic membrane includes growth factors and unique immune tolerance which can improve tissue regeneration. The preliminary studies could prove the potential value of dHAM in the reconstruction of the urinary tract and nerve protection. The investigators initially present a randomized trial to improve postoperative continence and potency of patients undergoing placement of dehydrated human amnion membrane (dHAM) around the neurovascular bundle (NVB) and vesicourethral anastomosis (VUA) during RRP for the treatment of prostate cancer. RRP is performed in a standardized way by one experienced surgeon. The patients are randomized 1:1 to dHAM vs. placebo and blinded during the study period. The primary outcome is a postoperative continence measure as 24hrs pad test up to 12mos postoperatively. Secondary outcomes are potency, insufficiency of VUA, postoperative complications and biochemical recurrence. Using the T-test with an alpha of 0.05 and a power of 80% and expecting a drop-out of 20% of the patients, an adjusted sample size per arm of 164 patients is required.
- Conditions
- Continence, Potency, Complication, Biochemical Recurrence
- Being tested
- dHAM, No dHAM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dHAMDrug
A dehydrated human amnion membrane (dHAM, 1x3cm) is placed around the neurovascular bundle (NVB) on the left and right side and vesicourethral anastomosis (VUA) during radical retropubic prostatectomy (RRP).
No dHAMDrug
A standard radical retropubic prostatectomy (RRP) without dHAM is performed (Walsh, 2005).
| Study group | Role | What they receive |
|---|---|---|
| dHAM | Experimental | dHAM wrap is placed during RRP. Receives: Drug: dHAM |
| Standard | Placebo comparator | A standard RRP is performed. Receives: Drug: No dHAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urine loss
Urine loss is assessed by 24 hrs pad-test (in gram)
Measured: From baseline (1 week after surgery) to 3 weeks after surgery
Change in urine loss
Urine loss is assessed by 24 hrs pad-test (in gram)
Measured: From baseline (1 week after surgery) to 6 weeks after surgery
Change in urine loss
Urine loss is assessed by 24 hrs pad-test (in gram)
Measured: From baseline (1 week after surgery) to 3 months after surgery
Change in urine loss
Urine loss is assessed by 24 hrs pad-test (in gram)
Measured: From baseline (1 week after surgery) to 12 months after surgery
Secondary outcomes (6)
Change in erectile function (EF)
EF is assessed by IIEF-5 (the International Index of Erectile Function) questionnaire.
Measured: From baseline (4 weeks before surgery) to 6 weeks after surgery
Change in erectile function (EF)
EF is assessed by IIEF-5 (the International Index of Erectile Function) questionnaire.
Measured: From baseline (4 weeks before surgery) to 3 months after surgery
Change in erectile function (EF)
EF is assessed by IIEF-5 (the International Index of Erectile Function) questionnaire.
Measured: From baseline (4 weeks before surgery) to 12 months after surgery
Postoperative catheter removal
Time of postoperative catheter removal (days)
Measured: through study completion, an average of 1 year
Complications
Complications are assessed according to Clavien-Dindo classification.
Measured: perioperative, at 6 weeks, 3 months and 12 months
Biochemical recurrence
Measurement of prostate-specific antigen (PSA)
Measured: at 6 weeks, 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for ContinenceStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Centre for Assessment and Evaluation of Innovative Techniques in Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitri Barski, Lukas-Krankenhaus GmbH
- Investigators
- Dimitri Barski, PhD, Principal investigator, Department of Urology, Lukas Hospital Neuss
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864939
- Sponsor's protocol ID
- HAM01
- Status last verified
- Mar 2019
- First submitted
- 3 Mar 2019
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abrams P, Andersson KE, Apostolidis A, Birder L, Bliss D, Brubaker L, Cardozo L, Castro-Diaz D, O'Connell PR, Cottenden A, Cotterill N, de Ridder D, Dmochowski R, Dumoulin C, Fader M, Fry C, Goldman H, Hanno P, Homma Y, Khullar V, Maher C, Milsom I, Newman D, Nijman RJM, Rademakers K, Robinson D, Rosier P, Rovner E, Salvatore S, Takeda M, Wagg A, Wagner T, Wein A; members of the committees. 6th International Consultation on Incontinence. Recommendations of the International Scientific Committee: EVALUATION AND TREATMENT OF URINARY INCONTINENCE, PELVIC ORGAN PROLAPSE AND FAECAL INCONTINENCE. Neurourol Urodyn. 2018 Sep;37(7):2271-2272. doi: 10.1002/nau.23551. Epub 2018 Aug 14. No abstract available.
PubMed 30106223Asimakopoulos AD, Miano R, Galfano A, Bocciardi AM, Vespasiani G, Spera E, Gaston R. Retzius-sparing robot-assisted laparoscopic radical prostatectomy: Critical appraisal of the anatomic landmarks for a complete intrafascial approach. Clin Anat. 2015 Oct;28(7):896-902. doi: 10.1002/ca.22576. Epub 2015 Jul 21.
PubMed 26194970Barski D, Gerullis H, Ecke T, Varga G, Boros M, Pintelon I, Timmermans JP, Otto T. Human Amniotic Membrane Is Not Suitable for the Grafting of Colon Lesions and Prevention of Adhesions in a Xenograft Rat Model. Surg Innov. 2017 Aug;24(4):313-320. doi: 10.1177/1553350617709828. Epub 2017 May 26.
PubMed 28548553Barski D, Gerullis H, Ecke T, Varga G, Boros M, Pintelon I, Timmermans JP, Otto T. Human amniotic membrane dressing for the treatment of an infected wound due to an entero-cutaneous fistula: Case report. Int J Surg Case Rep. 2018;51:11-13. doi: 10.1016/j.ijscr.2018.08.015. Epub 2018 Aug 13.
PubMed 30130666Barski D, Gerullis H, Ecke T, Varga G, Boros M, Pintelon I, Timmermans JP, Winter A, Bagner JW, Otto T. Repair of a vesico-vaginal fistula with amniotic membrane - Step 1 of the IDEAL recommendations of surgical innovation. Cent European J Urol. 2015;68(4):459-61. doi: 10.5173/ceju.2015.683. Epub 2015 Nov 13.
PubMed 26855802Barski D, Gerullis H, Ecke T, Yang J, Varga G, Boros M, Pintelon I, Timmermans JP, Otto T. Bladder Reconstruction with Human Amniotic Membrane in a Xenograft Rat Model: A Preclinical Study. Int J Med Sci. 2017 Mar 11;14(4):310-318. doi: 10.7150/ijms.18127. eCollection 2017.
PubMed 28553162Capogrosso P, Salonia A, Briganti A, Montorsi F. Postprostatectomy Erectile Dysfunction: A Review. World J Mens Health. 2016 Aug;34(2):73-88. doi: 10.5534/wjmh.2016.34.2.73. Epub 2016 Aug 23.
PubMed 27574591D'Amico AV, Whittington R, Malkowicz SB, Schultz D, Blank K, Broderick GA, Tomaszewski JE, Renshaw AA, Kaplan I, Beard CJ, Wein A. Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. JAMA. 1998 Sep 16;280(11):969-74. doi: 10.1001/jama.280.11.969.
PubMed 9749478Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542Lemke A, Ferguson J, Gross K, Penzenstadler C, Bradl M, Mayer RL, Gerner C, Redl H, Wolbank S. Transplantation of human amnion prevents recurring adhesions and ameliorates fibrosis in a rat model of sciatic nerve scarring. Acta Biomater. 2018 Jan 15;66:335-349. doi: 10.1016/j.actbio.2017.11.042. Epub 2017 Nov 28.
PubMed 29191510Ogaya-Pinies G, Kadakia Y, Palayapalayam-Ganapathi H, Woodlief T, Jenson C, Syed J, Patel V. Use of Scaffolding Tissue Biografts To Bolster Vesicourethral Anastomosis During Salvage Robot-assisted Prostatectomy Reduces Leak Rates and Catheter Times. Eur Urol. 2018 Jul;74(1):92-98. doi: 10.1016/j.eururo.2016.10.004. Epub 2016 Oct 14.
PubMed 27751731Ogaya-Pinies G, Palayapalam-Ganapathi H, Rogers T, Hernandez-Cardona E, Rocco B, Coelho RF, Jenson C, Patel VR. Can dehydrated human amnion/chorion membrane accelerate the return to potency after a nerve-sparing robotic-assisted radical prostatectomy? Propensity score-matched analysis. J Robot Surg. 2018 Jun;12(2):235-243. doi: 10.1007/s11701-017-0719-8. Epub 2017 Jun 27.
PubMed 28656504Patel VR, Samavedi S, Bates AS, Kumar A, Coelho R, Rocco B, Palmer K. Dehydrated Human Amnion/Chorion Membrane Allograft Nerve Wrap Around the Prostatic Neurovascular Bundle Accelerates Early Return to Continence and Potency Following Robot-assisted Radical Prostatectomy: Propensity Score-matched Analysis. Eur Urol. 2015 Jun;67(6):977-980. doi: 10.1016/j.eururo.2015.01.012. Epub 2015 Jan 19.
PubMed 25613153Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997 Jun;49(6):822-30. doi: 10.1016/s0090-4295(97)00238-0.
PubMed 9187685Walsh PC. Re: Anatomical radical retropubic prostatectomy: detailed description of the surgical technique. J Urol. 2005 Jan;173(1):324. doi: 10.1097/01.ju.0000148246.73337.ad. No abstract available.
PubMed 15592108
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Pilot Study to Improve Postprostatectomy Incontinence and Potency by Application of Dried Human Amnion Graft
- ClinicalTrials.gov ID
- NCT03864939
- Acronym / sponsor ID
- HAM01
- Conditions
- Continence, Potency, Complication, Biochemical Recurrence
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- German Centre for Assessment and Evaluation of Innovative Techniques in MedicineUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 6 Mar 2019 (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.
The investigators present a randomized trial of patients undergoing placement of dehydrated human amnion membrane (dHAM) around the neurovascular bundle (NVB) and vesicourethral anastomosis (VUA) during radical retropubic prostatectomy (RRP) in a tertiary center in Germany.
Detailed description
Patients suffer under incontinence and impotence after RRP, improving techniques and studies are missing. The human amniotic membrane includes growth factors and unique immune tolerance which can improve tissue regeneration. The preliminary studies could prove the potential value of dHAM in the reconstruction of the urinary tract and nerve protection. The investigators initially present a randomized trial to improve postoperative continence and potency of patients undergoing placement of dehydrated human amnion membrane (dHAM) around the neurovascular bundle (NVB) and vesicourethral anastomosis (VUA) during RRP for the treatment of prostate cancer. RRP is performed in a standardized way by one experienced surgeon. The patients are randomized 1:1 to dHAM vs. placebo and blinded during the study period. The primary outcome is a postoperative continence measure as 24hrs pad test up to 12mos postoperatively. Secondary outcomes are potency, insufficiency of VUA, postoperative complications and biochemical recurrence. Using the T-test with an alpha of 0.05 and a power of 80% and expecting a drop-out of 20% of the patients, an adjusted sample size per arm of 164 patients is required.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dHAM | Experimental | Drug: dHAMdHAM wrap is placed during RRP. |
| Standard | Placebo comparator | Drug: No dHAMA standard RRP is performed. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with localized prostate cancer
- indication for radical prostatectomy
- no other treatment of prostate cancer
- availability to informed consent
Key exclusion criteria (7 listed)
- preoperative incontinence (24hrs pad-test)
- preoperative erectile dysfunction (IIEF-5 < 20)
- metastasized or locally advanced prostate cancer in preoperative assessment
- previous radiation of pelvis
- previous prostate cancer therapy
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 |
|---|---|---|
| dHAMA dehydrated human amnion membrane (dHAM, 1x3cm) is placed around the neurovascular bundle (NVB) on the left and right side and vesicourethral anastomosis (VUA) during radical retropubic prostatectomy (RRP). | Drug | dHAM |
| No dHAMA standard radical retropubic prostatectomy (RRP) without dHAM is performed (Walsh, 2005). | Drug | Standard |
Primary outcome
Change in urine loss
Time frame: From baseline (1 week after surgery) to 3 weeks after surgery
Urine loss is assessed by 24 hrs pad-test (in gram)
Change in urine loss
Time frame: From baseline (1 week after surgery) to 6 weeks after surgery
Urine loss is assessed by 24 hrs pad-test (in gram)
Change in urine loss
Time frame: From baseline (1 week after surgery) to 3 months after surgery
Urine loss is assessed by 24 hrs pad-test (in gram)
Change in urine loss
Time frame: From baseline (1 week after surgery) to 12 months after surgery
Urine loss is assessed by 24 hrs pad-test (in gram)
6 secondary outcomes
Change in erectile function (EF)
Time frame: From baseline (4 weeks before surgery) to 6 weeks after surgery
Change in erectile function (EF)
Time frame: From baseline (4 weeks before surgery) to 3 months after surgery
Change in erectile function (EF)
Time frame: From baseline (4 weeks before surgery) to 12 months after surgery
Postoperative catheter removal
Time frame: through study completion, an average of 1 year
Complications
Time frame: perioperative, at 6 weeks, 3 months and 12 months
Biochemical recurrence
Time frame: at 6 weeks, 3 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Background: PubMed 30106223Abrams P, Andersson KE, Apostolidis A, Birder L, Bliss D, Brubaker L, Cardozo L, Castro-Diaz D, O'Connell PR, Cottenden A, Cotterill N, de Ridder D, Dmochowski R, Dumoulin C, Fader M, Fry C, Goldman H, Hanno P, Homma Y, Khullar V, Maher C, Milsom I, Newman D, Nijman RJM, Rademakers K, Robinson D, Rosier P, Rovner E, Salvatore S, Takeda M, Wagg A, Wagner T, Wein A; members of the committees. 6th International Consultation on Incontinence. Recommendations of the International Scientific Committee: EVALUATION AND TREATMENT OF URINARY INCONTINENCE, PELVIC ORGAN PROLAPSE AND FAECAL INCONTINENCE. Neurourol Urodyn. 2018 Sep;37(7):2271-2272. doi: 10.1002/nau.23551. Epub 2018 Aug 14. No abstract available.
- Background: PubMed 26194970Asimakopoulos AD, Miano R, Galfano A, Bocciardi AM, Vespasiani G, Spera E, Gaston R. Retzius-sparing robot-assisted laparoscopic radical prostatectomy: Critical appraisal of the anatomic landmarks for a complete intrafascial approach. Clin Anat. 2015 Oct;28(7):896-902. doi: 10.1002/ca.22576. Epub 2015 Jul 21.
- Background: PubMed 28548553Barski D, Gerullis H, Ecke T, Varga G, Boros M, Pintelon I, Timmermans JP, Otto T. Human Amniotic Membrane Is Not Suitable for the Grafting of Colon Lesions and Prevention of Adhesions in a Xenograft Rat Model. Surg Innov. 2017 Aug;24(4):313-320. doi: 10.1177/1553350617709828. Epub 2017 May 26.
- Background: PubMed 30130666Barski D, Gerullis H, Ecke T, Varga G, Boros M, Pintelon I, Timmermans JP, Otto T. Human amniotic membrane dressing for the treatment of an infected wound due to an entero-cutaneous fistula: Case report. Int J Surg Case Rep. 2018;51:11-13. doi: 10.1016/j.ijscr.2018.08.015. Epub 2018 Aug 13.
- Background: PubMed 26855802Barski D, Gerullis H, Ecke T, Varga G, Boros M, Pintelon I, Timmermans JP, Winter A, Bagner JW, Otto T. Repair of a vesico-vaginal fistula with amniotic membrane - Step 1 of the IDEAL recommendations of surgical innovation. Cent European J Urol. 2015;68(4):459-61. doi: 10.5173/ceju.2015.683. Epub 2015 Nov 13.
- Background: PubMed 28553162Barski D, Gerullis H, Ecke T, Yang J, Varga G, Boros M, Pintelon I, Timmermans JP, Otto T. Bladder Reconstruction with Human Amniotic Membrane in a Xenograft Rat Model: A Preclinical Study. Int J Med Sci. 2017 Mar 11;14(4):310-318. doi: 10.7150/ijms.18127. eCollection 2017.
- Background: PubMed 27574591Capogrosso P, Salonia A, Briganti A, Montorsi F. Postprostatectomy Erectile Dysfunction: A Review. World J Mens Health. 2016 Aug;34(2):73-88. doi: 10.5534/wjmh.2016.34.2.73. Epub 2016 Aug 23.
- Background: PubMed 9749478D'Amico AV, Whittington R, Malkowicz SB, Schultz D, Blank K, Broderick GA, Tomaszewski JE, Renshaw AA, Kaplan I, Beard CJ, Wein A. Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. JAMA. 1998 Sep 16;280(11):969-74. doi: 10.1001/jama.280.11.969.
- Background: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Background: PubMed 29191510Lemke A, Ferguson J, Gross K, Penzenstadler C, Bradl M, Mayer RL, Gerner C, Redl H, Wolbank S. Transplantation of human amnion prevents recurring adhesions and ameliorates fibrosis in a rat model of sciatic nerve scarring. Acta Biomater. 2018 Jan 15;66:335-349. doi: 10.1016/j.actbio.2017.11.042. Epub 2017 Nov 28.
- Background: PubMed 27751731Ogaya-Pinies G, Kadakia Y, Palayapalayam-Ganapathi H, Woodlief T, Jenson C, Syed J, Patel V. Use of Scaffolding Tissue Biografts To Bolster Vesicourethral Anastomosis During Salvage Robot-assisted Prostatectomy Reduces Leak Rates and Catheter Times. Eur Urol. 2018 Jul;74(1):92-98. doi: 10.1016/j.eururo.2016.10.004. Epub 2016 Oct 14.
- Background: PubMed 28656504Ogaya-Pinies G, Palayapalam-Ganapathi H, Rogers T, Hernandez-Cardona E, Rocco B, Coelho RF, Jenson C, Patel VR. Can dehydrated human amnion/chorion membrane accelerate the return to potency after a nerve-sparing robotic-assisted radical prostatectomy? Propensity score-matched analysis. J Robot Surg. 2018 Jun;12(2):235-243. doi: 10.1007/s11701-017-0719-8. Epub 2017 Jun 27.
- Abrams P, Cardozo L, Khoury S, Wein A. 2005. Incontinence Basics\& Evaluation, 3rd International Consultation on Incontinence. Chapter 13: Imaging and other Investigations.Link provided by the sponsor.
- 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.
Dimitri Barski, PhD principal investigator
Department of Urology, Lukas Hospital Neuss
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing dHAM and No dHAM in people with Continence and Potency, run by German Centre for Assessment and Evaluation of Innovative Techniques in Medicine 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 4 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: status not confirmed, as of the sponsor's last update on 6 Mar 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Dimitri Barski, PhD (004921318882401, dbarski@lukasneuss.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urine loss (time frame: From baseline (1 week after surgery) to 3 weeks after surgery). The study lists 4 primary outcomes in all. 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 NCT03864939, which also lists 16 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 6 Mar 2019.