Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201811741131369 Date of Registration: 02/11/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Pelvic floor rehabilitation in women undergoing pelvic floor reconstructive surgery
Official scientific title Pelvic floor rehabilitation in women undergoing pelvic floor reconstructive surgery
Brief summary describing the background and objectives of the trial RATIONALE: Pelvic organ prolapse occurs in 46-73% of women in South Africa (Cronjé, s.a.: online). Post-surgery vaginal wall prolapse may be recurrent in up to 30% to 50% of women (Digesu et al. 2010:1013). It is suggested that pelvic floor muscle (PFM) training can be important to prevent recurrence of pelvic floor disorders because accurate rehabilitation of the pelvic floor muscles can aid in its recovery. It can also provide additional support for the pelvic organs which cannot necessarily be improved with surgery (Bo, Berghmans, Morkved & Van Kampen 2007:243). It is not known what the effect of corrective surgery on PFM function is and how it can be affected by physiotherapeutic intervention. In order to answer this and generate clinically relevant evidence, PFM training should be scientifically prescribed and investigated according to the latest evidence on motor control and rehabilitation principles (Hagen, Stark, Maher & Adams 2009:1; Bo et al. 2007:87-88,237). There are conservative treatment protocols for PFM training but they are based on limited evidence. There is also a lack of standardisation in the prescription of treatment protocols for pelvic organ prolapse (POP) when compared to the general principles of rehabilitation (Braekken, Majida, Eng & Bo 2010:170e7; Quartly, Hallam, Kilbreath & Refshauge 2010:312). A recent Cochrane review indicated that clinical trials are needed to assess the effect of PFM training in conjunct with surgery for POP rehabilitation. It is important because the evidence is insufficient to draw any meaningful conclusions (Hagen et al. 2009:2,8). PROBLEM STATEMENT: PFM training for POP is under-investigated. The complete lack of outcome evidence does not justify the current use of PFM training programmes. This is because the programmes are not based on sound rehabilitation principles. It calls for urgent randomised, clinical trials to assess the effect of PFM training in patients with POP pre-operatively and
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Obstetrics and Gynecology,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied Pelvic organ prolapse
Purpose of the trial Rehabilitation
Anticipated trial start date 03/06/2013
Actual trial start date 07/10/2013
Anticipated date of last follow up 15/01/2016
Actual Last follow-up date 25/01/2016
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 81
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Core stability training Patient-specific exercise prescription, with follow-up every two weeks, including a daily home programme 6 months Exercises for the transversus abdominus muscle, pelvic floor muscles, and lifestyle advice. Progressed individually based on the participant`s performance according to the motor control model of rehabilitation. 28
Experimental Group Pelvic floor exercise programme Sets of 8-12 pelvic floor muscle contractions, three times a day. Follow up every second week, including a home exercise programme 6 months Isolated pelvic floor muscle contractions, the sets and amount of contractions based on the participant`s performance. 24
Control Group Control Not applicable - it included standard treatment, namely home advice on what to do in the case of incontinence when coughing, sneezing, etc. 6 months Participants received advice and education on pelvic organ prolapse and incontinence, which included practical advice on what to do when leaking when coughing, sneezing, etc. I also included advice on lifestyle which could be beneficial to adapt to prevent future complications. 29 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Women over eighteen (18) years of age (Norton et al. 2007:4), • women scheduled for corrective surgery for POP (including Perineo-colpo-sacro-suspension (sacrocolpopexy), anterior and posterior Prolift or Avaulta, total Prolift or Avaulta, anterior and posterior repair, sacrospinous colpofixation), • participants that are able to adhere and comply to keep a treatment diary and execute a home exercise programme, • Caucasian, Asian and Coloured women. • Women suffering from neuromusculoskeletal disorders (Jarvis et al. 2005:301), • Diabetes Mellitus, • psycho-sexual problems (Norton et al. 2007:6; Laycock et al. 2001:22,31) or • obesity (body mass index >35); • pregnant women; • women older than 75 years; • women with stage IV POP (exclusion for phase I), • previous POP surgery where mesh was used, and • women who have had more than two previous operations for correction of POP; • women who will not be able to attend frequent follow-up visits over a period of six (6) months. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 75 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/03/2012 Health Research Ethics Committee of the University of the Free State
Ethics Committee Address
Street address City Postal code Country
205 Nelson Mandela drive, Park West Bloemfontein 9300 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Quality of life Pre-operatively, 6 weeks, three months, six months follow-up
Primary Outcome Pelvic floor and abdominal muscle function Pre-operatively, 6 weeks, three months and six months post-operatively
Secondary Outcome Exercise adherence, pain 6 weeks, 3 months and 6 months post-operatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Universitas Academic Hospital Pres Paul Kruger Avenue, Universitas Bloemfontein 9301 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Corlia Brandt Jubilee Road Johannesburg South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Corlia Brandt Polofields Drive Midrand South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
Dr EW Henn 205 Nelson Mandela Drive Bloemfontein 9301 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Corlia Brandt corlia.brandt@wits.ac.za +27117172014 Jubilee Road
City Postal code Country Position/Affiliation
Johannesburg South Africa Senior lecturer University of the Witwatersrand
Role Name Email Phone Street address
Public Enquiries Corlia Janse van Vuuren JanseVanVuurenEC@ufs.ac.za +27829210536 205 Nelson Mandela Drive
City Postal code Country Position/Affiliation
Bloemfontein 9300 South Africa Director Teaching and Learning University of the Free State
Role Name Email Phone Street address
Scientific Enquiries Corlia Brandt corlia.brandt@wits.ac.za +27117172014 Jubilee Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg South Africa Senior lecturer University of the Witwatersrand
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes Participants were a mean age of 59 years with predominantly stage III POP. Baseline outcomes indicated socio-economic, lifestyle and emotional impairment, as well as PF and abdominal muscle dysfunction. PFMT yielded the most significant changes regarding PF function during the first three months, including the LH during Valsalva (median change -3.5mm, 95% CI [-10.3;-1.8]), thickness of the perineal body (median change 1.5mm, 95% CI [0.5;4.1]), and endurance (median change 2sec, 95% CI [1;5]). Only group 2 showed significant changes in abdominal muscle function (Sahrmann and PBU levels, 95% CIs [1;3] and [1;9]) in addition to improved PF function up to six months. Although both intervention groups had some statistically significant muscle changes, no statistically significant differences were found in the magnitude of the changes among the three groups. Only group 2 yielded a statistical significant improvement in their P-QOL scores (95% CI [1.5;28.4]). 03/07/2017 15/12/2016
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks http://scholar.ufs.ac.za:8080/xmlui/handle/11660/5383 The final protocol are captured in the methodolody section of this document
Changes to trial information