Project description:Investigators propose a retrospective cohort study to examine the impact of radiation therapy on the global pelvic floor function of women who have completed the immediate surveillance period for colorectal cancer
Project description:Interventions: The pelvic floor intervention for rectal cancer patients will be delivered in two stages: (1) pre-rehabilitation and (2) rehabilitation. There is actual recommendation to provide rehabilitation before surgeries in order to prepare patients to improve their functional outcomes. The content of pre-rehabilitation and rehabilitation will include pelvic floor exercises and other techniques aiming to recover pelvic floor maximal function after the surgery and to avoid low anterior resection syndrome (LARS) symptoms.
The pelvic floor intervention, including all stages and techniques, will be provided by a physical therapist with a postgraduation study on pelvic floor treatment with experience in treating rectal cancer patients. This professional will be trained by researchers on the study protocol. The intervention will take place in a private room of Hospital del Salvador.
Stage 1: Pelvic Floor Pre-rehabilitation will be delivered in one session of approximately 40 minutes with physiotherapist educating on the correct contraction of pelvic floor, teaching pelvic floor muscle exercises, and performing capacitive and sensory training with rectal balloon.
Health education will include: the most adequate positioning to evacuate, self-care strategies such as diet with high fiber and low fat, reduce spicy and stimulating food (artificial sweeteners, tea, cola drinks and chocolates), and bowel habits (possibility to have increased urgency to defecate after meal or physical activities).
A booklet was designed for this study with these instructions and exercises will be provided to the patients as well as an audio that will be sent to their cell phones using Whatsapp application. A mobile number with a whatsapp account will be maintained by the pelvic floor therapist to se
Primary outcome(s): Mean score of bowel symptoms
For the main outcome we will use the questionnaire ICIQ-B and the LARS score.[(T3) Three months after finishing pelvic floor rehabilitation treatment (PRIMARY TIMEPOINT)
(T2) Immediatelly after pelvic floor rehabilitation
(T0) baseline];Mean scores of anorectal function.
High resolution anorectal manometry will be used to assess the maximal resting pressure, maximal squeeze pressure, rectal capacity (maximal tolerable volume), and rectal sensitivity (initial sensation threshold). We will use high resolution anorectal manometry with a 24-channels water-perfused catheter (Multiplex, Alacer, Biomedica, Sao Paulo, Brazil). This equipment is a low-cost water perfused system which showed to be adequate for clinical use (Silva et al, 2018; Viebig et al, 2018). According to a previous study we will define as effective an improvement of > 15% in the anorectal manometry parameters. This test will be performed by a trained physician.
Silva RMB, Herbella FAM, Gualberto D. Normative values for a new wáter-perfused high resolution manometry system. Arq Gastroenterol 2018; 55:30-34
Viebig RG, Franco JTY, Araujo SV, Gualberto D. Water-perfused high-resolution anorectal manometry (hram-wp): the first brazilian study. Arq. Gastroenterol. 2018;55(Suppl 1):41-46.
[(T3) Three months after finishing pelvic floor rehabilitation treatment (PRIMARY TIMEPOINT) (T2) Immediatelly after pelvic floor rehabilitation
(T1) before rehabilitation - standardized at approximately 6 months of ostomy use after rectal cancer surgery
(T0) baseline]
Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy
Project description:Upload 2. Test data from multiple pelvic floor muscles from rats. Data was acquired using a Bruker Maxis Impact and C18 RP-UHPLC. Positive polarity acquisition of LC-MS/MS.
Project description:Interventions: Name: Pelvic floor rehabilitation program
Rationale: Patients after anterior resection +/- radiochemotherapy for colorectal cancer can suffer from bowel dysfunction that includes faecal incontinence and defaecatory problems. A structured pelvic floor rehabilitation program on pelvic floor muscle strengthening, anorectal sensory and coordination training can improve bowel function after surgery. This study will also examine the feasibility of the intervention in an outpatient setting.
Intervention: A 15 minutes of education session will be provided at the commencement of the program at first week. Participants will be provided education on normal bowel function and the bowel issues associated with colorectal cancer surgery. They will also receive information on good bladder and bowel habits, dietary advice, and pelvic floor exercises.The educational information and home exercise pamphlet is specifically designed for this study. Each participant will be assessed on their anorectal physiology by a colorectal surgeon and pelvic floor physiotherapist. Patient reported outcomes on bladder, bowel, sexual function and quality of life will be examined with questionnaires before and after the intervention. The intervention is a 10 week face to face program of weekly attendance to the outpatient clinic for 1 hour under supervision (ie 1 hour session, once per week for 10 weeks in an outpatient clinic). The program includes: pelvic floor muscle strengthening with use of transperineal ultrasound for visual biofeedback, anorectal sensory and coordination retraining using rectal balloon catheter biofeedback. Visual feedback will be provided via the application of a transperineal ultrasound. The patient will be able to visualise the pelvic floor muscle activity on the screen du
Primary outcome(s): Adherence to pelvic floor rehabilitation program.Proportion with >80% attendance of supervised sessions. >80% of completion for weekly home exercises. This will be assessed by an attendance log and home exercise diary completion. [Post intervention program (12 weeks)]
Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy
Project description:Interventions: Control group + intervention group: LARS-score, Colorectal Functional Outcome Questionnaire, International Consulation on Incontinence Questionnaire, Female Sexual Function Index/ Interternational Index of Erectile Function, Flemish Physical Activity Questionnaire, Numeric Rating Scale, Bowel Diary, Bladder Diary, 1 hour Pad test, Evaluation pelvic floor muscles (tone, strength, endurance)
Intervention group: pelvic floor muscle training (9 times in 12 weeks)
High Resolution Pan Colonic manometry in a subset of patients with remaining symptoms
Primary outcome(s): LARS-score, evaluated after 12 weeks (=16 weeks after surgery/closure ileostomy) of pelvic floor muscle training
Study Design: Randomized controlled trial, Double blinded (masking used), Active, Parallel
Project description:Interventions: The intervention is general rehabilitation plus pelvic floor muscle training program. The general rehabilitation will consist of a multidisciplinary education and exercise program, which will be provided as group sessions twice weekly for 8 weeks . Each session will last approximately one hour. The education component will include advice about nutrition, exercise, fatigue management and coping with stress and will be provided in a group format. Information will be delivered by a range of clinicians (physiotherapists, occupational therapists, psychologists, and dieticians). The exercise component will include an exercise training program supervised by a physiotherapist. The pelvic floor muscle training program will consist of physiotherapy-supervised pelvic floor muscle training sessions and bladder and bowel function advice over 12 sessions, twice weekly for 6 weeks. The training program will use a combination of 7 individual and 5 group sessions. Biofeedback will be used to facilitate pelvic floor muscle function. The training sessions will be approximately one hour long. The duration of intervention is eight weeks. To encourage adherence to the intervention protocols, telephone calls from a physiotherapist and a self report diary to record training adherence will be provided.
Primary outcome(s): Pelvic floor symptoms as assessed using the Australian Pelvic Floor Questionnaire and the International Consultation on Incontinence Questionnaire Bowel module[at baseline, immediately post-intervention, and at 6, 12, 24, and 60 months following baseline]
Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel
Project description:<p>The overall purpose of this University of Utah Pelvic Organ Prolapse Disorder Study was to identify and localize predisposition genes contributing to pelvic organ prolapse (POP). POP cases recruited for this study were identified by one of three methods: high-risk POP pedigree cases, POP sister pairs, and surgically-treated POP cases reporting a family history of POP. <b>High-risk POP pedigree cases</b> were identified using the Utah Population Database (UPDB), a genealogy database of residents in Utah that has been linked to diagnostic ICD9 and CPT codes in medical records at the University of Utah and Intermountain Healthcare. We identified families with a significant excess number of POP cases compared to matched population rates and targeted these individuals for recruitment as well as any other POP cases in the family. <b>POP sister pair cases</b> were identified at the University of Utah Urogyncology clinic for women who had undergone POP surgery and also self-reported one or more sisters who were also surgically treated for POP. POP affection status of all sisters was confirmed either by physical examination or by chart review. <b>Surgically treated-POP cases reporting a family history of POP</b> were identified at the University of Utah Urogyncology clinic by self-report of a family history of POP. Efforts were made to recruit other affected family members and confirm affection status. To obtain DNA, subjects provided either a blood specimen or saliva. Medical records were reviewed by a urogynecologist and diagnostic information for pelvic organ prolapse and stress and overactive bladder were obtained. Collected DNA was genotyped and analyzed. To maintain confidentiality of the familial data, genetic data from only one subject per family has been submitted to dbGaP.</p> <p>Use of the University of Utah Pelvic Organ Prolapse Disorder Study data is limited to investigators studying pelvic floor disorders. These pelvic floor disorders include pelvic organ prolapse, urinary and anal incontinence, and other conditions related to weakening or injury to the muscles and connective tissue in the pelvis as a result of pelvic surgery, pregnancy, or vaginal delivery of a child. These data will be used only for research purposes related to pelvic floor disorders. They will not be used to determine the individual identity of any person or their relationship to another person or for research on non-disease traits.</p>
Project description:Obstetrical perineal and anal sphincter lacerations can be associated with considerable sequelae. The diagnosis of short-term bowel, bladder, and healing problems can be delayed if patients are not seen until the traditional postpartum visit at 4 to 6 weeks. Specialized peripartum clinics create a unique opportunity to collaborate with obstetrical specialists to provide early, individualized care for patients experiencing a variety of pelvic floor issues during pregnancy and in the postpartum period. Although implementation of these clinics requires thoughtful planning and partnering with care providers at all levels in the obstetrics care system, many of the necessary resources are available in routine gynecologic practice. Using a multidisciplinary approach with pelvic floor physical therapists, nurses, advanced practice providers, and other specialists is important for the success of this service line and enhances the level of care provided. Overall, these clinics provide a structured means by which pregnant and postpartum women with pelvic floor symptoms can receive specialized counseling and treatment.