Application of Dried Human Amnion Graft to Improve Postprostatectomy Incontinence and Potency

German Centre for Assessment and Evaluation of Innovative Techniques in Medicine

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Complication; Potency; Biochemical Recurrence; Continence

Treatments: Drug: dHAM; Drug: No dHAM

Study type: Interventional

Funder types: Other

Identifiers

NCT03864939

HAM01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 328 estimated patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with localized prostate cancer
• indication for radical prostatectomy
• no other treatment of prostate cancer
• availability to informed consent

Exclusion criteria

• 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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

328 participants in 2 patient groups, including a placebo group

dHAM

Experimental group

Description:

dHAM wrap is placed during RRP.

Treatment:

Drug: dHAM

Standard

Placebo Comparator group

Description:

A standard RRP is performed.

Treatment:

Drug: No dHAM