Hyalofemme is a cream/gel containing hyaluronic acid, designed to be applied vaginally. This is primarily used in treatment of atrophic vaginitis and is applied by the patient once every three days. We intend treatment to continue for 6 months.

Ialuril is a bladder instillation designed to be delivered to the bladder via catheter. This is primarily used in patients suffering from recurrent UTI and acts to help rebuild the lining of the bladder, reducing irritation. Ialuril is applied weekly for 6 weeks, followed by every 2 weeks for 6 weeks, then once monthly for maintenance. Treatment will be continued for 6 months.

Atrophic Vaginitis

Urinary Tract Infections

Gel made with hyaluronic acid to be applied vaginally to treat atrophic vaginitis.

Hyalofemme

Bladder instillation of hyaluronic acid to treat recurrent UTI.

Ialuril

Freeman Hospital

Hyaluronate for the Treatment and Prevention of Recurrent Urinary Tract Infection in Women Suffering Atrophic Vaginitis

Occurrence of symptomatic UTI with prescription and taking of a treatment course of antibiotics for UTI. Applicable for both treatment arms in comparison to baseline established in the previous 12 months.

Occurrence of symptomatic UTI and the demonstration of a positive urine culture, rather than UTI symptoms potentially caused by interstitial cystitis without bacterial infection.

The two treatment arms will be compared to baseline to discover whether any improvement in vaginal atrophy symptoms are seen with either treatment. This will be assessed via questionnaires to determine symptoms experienced and their severity at 0 (baseline), 3, 6 and 9 months. Symptoms that participants will be asked to assess are as follows:
Frequency of urination
Urgency of urination
Pain or burning during urination
Partial bladder emptying
Fever or shivers
Pain in the lower abdomen or pelvis
Lower back pain
Blood in the urine Participants will rank the severity of these symptoms from "Did not have" to "Severe", and how troublesome they were from "Not at all" to "A lot" by marking a line to indicate where the participant feels their symptoms lie. Upon analysis of the questionnaires, placement of this mark will be measured and used to determine differences in symptoms from baseline throughout the study.

Urine samples will be analysed for the presence of bacteria. If any are found they will be cultured, identified and potentially undergo molecular typing to discover whether particular strains are more prevalent in patients suffering from concurrent rUTI and atrophic vaginitis.

Urine and vaginal douche samples will be collected at baseline and at 3-monthly intervals. These will be analysed by ELISA for the presence of innate immune markers and cytokines, such as defensins, interleukin-8 and lipocalin. A potential change in expression may indicate that this is partly how the treatments help to prevent against UTI.

Patient blood samples will be collected at baseline and DNA extracted. These will be examined for SNPs in genes such as TLR5, which encodes a receptor protein known to affect patient response to bacteria in cases of UTI.

Participants will be asked to complete questionnaires (EQ-5D) pertaining to their overall health and quality of life at baseline and at 3-monthly intervals to determine whether treatments are improving their overall health and general wellbeing at 0, 3, 6 and 9 months. This is a validated questionnaire commonly used in healthcare to determine general health and includes assessments of mobility, self-care, ability to carry out normal activity, pain/discomfort levels and anxiety/depression. This also asks participants to assess their overall health state by marking on a scale from 0-100, with higher numbers representing the best imaginable state of health.

Incidences of antibiotic use, in general and specifically for UTI, will be recorded to observe whether the treatments result in fewer courses of antibiotics being prescribed.

Newcastle-upon-Tyne Hospitals NHS Trust

The Urology Foundation, UK

Atrophic vaginitis and recurrent urinary tract infection are often found concurrently in post-menopausal women. The argument over which condition appeared first, or if one is caused by the other, is prevalent in clinical settings and there is no official guidance as to which should be treated first. We propose two arms to this study - one treating the atrophic vaginitis via use of Hyalofemme cream (hyaluronate cream), and the other treating recurrent UTI by use of Ialuril (hyaluronate bladder instillation). We intend to investigate the effect on the incidence of UTI in the patients with both treatments, as well as focusing on some markers of the immune response in the urine and vaginal douche samples from these participants.

Use TGF to treat osteoarthritis of the knee, 5g/time, 3 times a day, for 12 weeks.

Use TGFP to treat osteoarthritis of the knee, 5g/time, 3 times a day, for 12 weeks.

Osteoarthritis, Knee

TGF is a powder formulation of Hu-Qian Wan (HQW). HQW is composited of 10 herbs, Chinemys reevesii (Gray), Phellodendron chinense Schneid., Achyranthes bidentata Blume, Anemarrhena asphodeloides Bunge, Rehmannia glutinosa Libosch., Paeonia lactiflora Pall., Cynomorium songaricum Rupr., Angelica sinensis (Oliv.) Diels, Citrus reticulata Blanco and Zingiber officinale Rosc..

TGFP is 1/20 concentration of Hu-Qian Wan (HQW). HQW is composited of 10 herbs, Chinemys reevesii (Gray), Phellodendron chinense Schneid., Achyranthes bidentata Blume, Anemarrhena asphodeloides Bunge, Rehmannia glutinosa Libosch., Paeonia lactiflora Pall., Cynomorium songaricum Rupr., Angelica sinensis (Oliv.) Diels, Citrus reticulata Blanco and Zingiber officinale Rosc..

TGFP

The Efficacy of TGF for Treating Osteoarthritis of the Knee

The Efficacy of TGF for Treating Osteoarthritis of the Knee: A Randomized Double-blind Controlled Trial

This scale is the VAS version, 3.1 and divided into three sub-scales -- pain, stiffness and function. Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing. Stiffness (2 items): after first waking and later in the day. Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties. Each item has 0-100 mm to evaluate the status and the higher values represent a worse outcome. These three sub-scales were summed to a total score (0-2400 mm).

To evaluate the status of knee pain when check point. Using 0-100 mm scale is to evaluate knee pain by visual analogue scale. "0" is no pain and "100" is the worst pain that subjects had experienced before. The subject gives the value under the moment of check point.

To evaluate the dosage of Celebrex when check point

knee joint that associated with this study

For evaluating the constitution. This scale (Constitution in Chinese Medicine Questionnaire) includes nine constitutions and each constitution has 6-8 items that used 1-5 points to evaluate the degree. "1" means "better" and "5" means "worse". The transformed points is equal to [(original points - the number of items)/(the number of itmes*4) ]*100.

For evaluating the quality of life. This scale is "World Health Organization Quality of Life - BREF". It contains 4 domains (Physical health, Psychological, Social relationships and Environment) and 26 items ("1" means "worse" and "5" means "better"). This scale used the following steps to calculate the transformed points: 1.Check all 26 items from assessment have a range of 1-5, 2.Reverse 3 negatively phrased items, 3.Compute domain scores, 4. Delete cases with >20% missing data, 5.Check domain scores.

For evaluating the status of inflammation. Erythrocyte Sedimentation Rate (ESR) actually measures the rate of fall (sedimentation) of erythrocytes (red blood cells) in a sample of blood that has been placed into a tube. Results are reported as the millimeters of clear fluid (plasma) that are present at the top portion of the tube after one hour. The higher value means more inflammation.

This study uses ELISA kit to measure the concentraion (pg/ml) of C-Telopeptide of Type II Collagen (CTX-II) .

This study uses ELISA kit to measure the concentraion (ng/ml) of Cartilage Oligomeric Matrix Protein (COMP) .

This study uses ELISA kit to measure the concentraion (ng/ml) of Osteocalcin .

This study uses ELISA kit to measure the concentraion (pg/ml) of Leptin.

This study uses ELISA kit to measure the concentraion (ng/ml) of interleukin-1 (IL-1).

This study uses ELISA kit to measure the concentraion (ng/ml) of interleukin-6 (IL-6).

This study uses ELISA kit to measure the concentraion (ng/ml) of matrix metalloproteinase-3 (MMP-3).

This study uses ELISA kit to measure the concentraion (pg/ml) of matrix metalloproteinase-13 (MMP-13).

This study uses ELISA kit to measure the concentraion (ng/ml) of a disintegrin and metalloproteinase with thrombospondin motifs-4 (ADAMTS-4).

This study uses ELISA kit to measure the concentraion (ng/ml) of Transglutaminase 2 (TG-2).

The metabolite of the drugs. This measurement used LC-MS to get the molecular weight of Chinese herbal metabolites form blood, urine and synovial fluid. This method can help to identify the active substance from the formula (TGF). Here, we cannot to know the exactly active substance that we will get.

the expression of mRNA in PGC-1α by quantitative polymerase chain reaction

the expression of mRNA in NRF1 by quantitative polymerase chain reaction

the expression of mRNA in mtTFA by quantitative polymerase chain reaction

the expression of protein in PGC-1α by Western blotting

the expression of protein in NRF1 by Western blotting

the expression of protein in mtTFA by Western blotting

anti-oxidant capacity by OxiSelectTM Trolox Equivalent Antioxidant Capacity (TEAC) Assay Kit (ABTS)

For evaluating the status of inflammation. High-sensitivity C-reactive Protein is a protein that increases in the blood with inflammation and infection as well as following a heart attack, surgery, or trauma. Thus, it is one of several proteins that are often referred to as acute phase reactants. The high-sensitivity CRP test measures low levels of CRP in the blood to identify low levels of inflammation that are associated with risk of developing cardiovascular disease (CVD).

vaccinium/atrofi

Hyaluronate for the Treatment and Prevention of Recurrent Urinary Tract Infection in Women Suffering Atrophic Vaginitis

The Efficacy of TGF for Treating Osteoarthritis of the Knee

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