To investigate the collagen metabolism in pelvic floor tissue, pelvic floor-derived fibroblasts, and adipose tissue stem cells in patients with and without pelvic organ prolapse (POP)
ID
Source
Brief title
Collagen metabolism and pelvic organ prolapse; a pilot study
Condition
- Connective tissue disorders (excl congenital)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter/endpoint
·Determination of the production, crosslinking status and degradation profiles
of the different collagen types in patients with and without POP in relation to
age, parity, BMI, and POP status
· Comparison of the collagen metabolism of differentiated stem cells and
vaginal fibroblasts, of patients with and without POP.
Secondary outcome
Secundary study parameters
Not applicable
Background summary
Genital Prolaps (=POP) is an increasing problem. Treatment modalities are
pessary therapy or surgery. In thirty percent of the cases recurrence of the
prolapse occurs after surgery. To improve the results of prolapse surgery the
use of meshes is introduced, for example synthetic polypropyleen. Meshes
maintain their tensile strenght, but have a substantial risk of rejection
because they do not dissolve.
Other organic meshes dissolve gradually and do not provoke an immune reaction,
i.e. rejection of the mesh. However they loose their tensile strenght and are
not effective.
Ideally, treatment of POP should be regenerating the vaginal prolapsed tissue
instead of replacing the tissue by a mesh. We have to obtain more knowledge,
however,about the specific defects in collagenmetabolisme in patiënts with POP,
in order to -hopefully one day- stimulate regeneration.
The collagen metabolism can be investigated by measuring the production and
breakdown of collagen. Also the type of collagen can be qualified and the
quality
of the fibroblasts, responsible for the production of collagen, can be
investigated.
According to the present state of science, there is a decrease in collagen
production and an increase in breakdown of collagen in patients with POP.
Future research should be based on the following questions.
· To determine whether collagen metabolism and collagen quality are affected in
patients with POP;
· To determine whether there is a causal relationship between POP and collagen
metabolism;
· To determine whether POP fibroblasts have an intrinsic defective collagen
metabolism, and if so, whether AT-MSCs can be used as an alternative source of
cells to be used for pelvic floor regeneration.
Study objective
To investigate the collagen metabolism in pelvic floor tissue, pelvic
floor-derived fibroblasts, and adipose tissue stem cells in patients with and
without pelvic organ prolapse (POP)
Study design
Prospective observational controlled study.
o The collagen metabolism of vaginal tissue will be compared in patients with
and without POP.
o In POP patients the collagen metabolism in vaginal tissue will be compared
according to the biopsy site: prolapse versus non prolapse.
o The collagen production of the vaginal fibroblast will be compared with
adipose tissue derived stem cells (AT-MSC) from the same patient, that are
stimulated to produce collagen. This is done both in POP- and non-POP patients.
Study burden and risks
During standard surgery (prolapse repair, hysterectomy) full thickness vaginal
tissue is attached to the the surgical specimen (uterus). This tissue from the
proximal vagina, measuring 0.5x4 cm is harvested In prolapse patients the strip
of the full thickness vagina that is * according to standard procedure --
excised from the prolapse site is examined as well. No additional procedure is
performed to collect the vaginal tissue. Ten cc of the periperitoneal adipose
tissue will be resected and transported to the department of pathology for
cultivation of adipose tissue-derived stem cells (AT-MSC). This space is
already open and easy accessible after removing the uterine specimen. There are
no additional risks for the patients participating. Patients have no direct
benefits from this investigation.
Postbus 7057
1007 MB Amsterdam
Nederland
Postbus 7057
1007 MB Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
- Women with POP undergoing vaginal hysterectomy with anterior and/or posterior repair, 35-75 years of age
- Women without POP undergoing abdominal or vaginal hysterectomy, 35-75 years of age
Exclusion criteria
- No informed consent
- Gynaecologic oncologic disease
- Chronic inflammatory diseases (RA) of chronic infections (HIV, hepatitis)
- Minors or incapacitated adults
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL17851.029.07 |