Clinical trial NCT05194137: Biofeedback Versus Vaginal Palpation to Teach a Voluntary Pelvic Floor Muscle Contraction
Official title: Biofeedback Versus Vaginal Palpation to Teach a Voluntary Pelvic Floor Muscle Contraction to Women Incapable of Performing it? A Non-inferiority Randomized Controled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The randomization of the participants will be done using a computer-generated list of numbers (www.randomization.com). This list will be put in a sealed envelope and participants allocation will be concealed.
Primary purpose: TREATMENT

Brief summary: Pelvic floor muscle training (PFMT) is the first line treatment of urinary incontinence (UI), anal incontinence (AI) and mild/moderate pelvic organ prolapse (POP) in women. However, 25 to 40% of women with pelvic floor dysfunction symptoms are unable to voluntarily contract their pelvic floor muscle (PFM) and PFM proprioception of this population is specially reduced. Literature is scarce about methods to facilitate a voluntary PFM contraction and improve PFM proprioception therefore, a specific protocol structured to teach PFM contraction is needed. The use of biofeedback could facilitate women´s capacity to voluntary contract their PFM.

Detailed description: Randomised, parallel (two arm), trial comparing biofeedback (experimental arm) versus vaginal palpation (active control, i.e. usual practice) to achieve a correct voluntary pelvic floor muscle contraction in women who cannot perform a correct contraction (i.e. grade 0, 1 or 2 on the Modified Oxford Scale). The trial hypothesis is that there is no difference between the two trial arms in the proportion of women achieving a correct voluntary contract (grade 3 or better).

The training protocol will be the same for both groups and will vary according to PFM function assessed at 0, 3, 6 and 9-week timepoint. The resting time after each contraction will be the double of the contraction duration, therefore if it is performed a 3-second contraction, it will be a 6-second rest. The first session will aim to improve some skills as understanding, searching, and finding PFM, the educational component of this session was structured considering Health Belief Model and will be conducted with the following information: 1) General information (female genital anatomy, female intern organs, pelvic floor muscle anatomy, pelvic floor muscle function), 2) specific information about urinary incontinence (definition of urinary incontinence, predictors of risk for urinary incontinence, impact on quality of life), 3) the relation between PFM and urinary incontinence, 4) pelvic floor muscle training as first line treatment for urinary incontinence, 5) how to include PFM proprioception protocol into daily life. It will be used as educational materials images and draws of the region and an educational booklet will be delivered to them. It will be shown to then a video of a PFM contraction emphasizing how the correct PFM contraction is supposed to be. The other sessions will focus will vary according to PFM function accessed at each timepoint:

* Participants classified with MOS 0 or 1: PFM protocol will aim on learning a PFM contraction and improve PFM perception
* Participants classified with MOS = 2: PFM protocol will aim on teaching how to control PFM contraction
* Participants classified with MOS ≥ 3: PFM protocol will aim on improving PFM strength

The resting time after each set will be 3 minutes and the protocol will evolve as following:

* WEEK 1: In clinics: 30 minutes: educational component as previous discussed. 30 minutes: The studied protocol will be explained as well as the need to fulfill a diary with their home training routine that should be delivered to the evaluator at the 12-week assessment. At each session, the physiotherapist will oversee the diary, take notes about the frequency of training, and orientate if necessary. To promote a first contact with their PFM, it will be performed 1 set of PFM contraction associated with vaginal palpation or biofeedback of 6 fast contraction according to the randomized group. The resting time after each contraction will be five seconds. Possible doubts will be clarified. At home: All participants will be oriented to perform 3 sets of 6 fast contraction daily during the following week in the supine position. The resting time after each contraction will be five seconds and after each set will be 2 minutes.
* WEEK 2-3: In clinics: Training diary will be overseen, and possible doubts will be clarified. Training protocol will be different according to PFM function assessed on week 0. MOS 0: 3 sets of 6 fast contraction. The resting time after each contraction will be five seconds and after each set will be 2 minutes. MOS 1: 3 sets of 6 fast contraction and 3 sets of 6 contractions sustained for 3 seconds. The resting time after each contraction will be five seconds and 2 minutes after each set. At home: Training protocol will be different according to PFM function assessed on week 0. MOS 0: 3 sets of 6 fast contraction in supine position. The resting time after each contraction will be five seconds and after each set will be 2 minutes. MOS 1: 3 sets of 6 fast contraction and 3 sets of 6 contractions sustained for 3 seconds in supine. The resting time after each contraction will be five seconds and 2 minutes after each set.
* WEEK 4-6: In clinics: Training diary will be overseen, and possible doubts will be clarified. Training protocol will be different according to PFM function assessed on week 3. MOS 0: 3 sets of 10 fast contraction. The resting time after each contraction will be five seconds and after each set will be 2 minutes. MOS 1: 3 sets of 10 fast contraction and 3 sets of 6 contractions sustained for 4 seconds. The resting time after each contraction will be six seconds and 2 minutes after each set. MOS ≥ 2: 3 sets of 10 fast contraction and 3 sets of 10 contractions sustained for 6 seconds. The resting time after each contraction will be ten seconds and 3 minutes after each set. At home: Training protocol will be different according to PFM function assessed on week 3. MOS 0: 3 sets of 10 fast contraction, each set on a different position (i.e. supine, sitting and standing). The resting time after each contraction will be five seconds and after each set will be 2 minutes. MOS 1: 3 sets of 10 fast contraction and 3 sets of 6 contractions sustained for 4 seconds. Each set is supposed to be performed on a different position (i.e. supine, sitting and standing). The resting time after each contraction will be six seconds and 2 minutes after each set. MOS ≥ 2: 3 sets of 10 fast contraction and 3 sets of 10 contractions sustained for 6 seconds. Each set is supposed to be performed on a different position (i.e. supine, sitting and standing). The resting time after each contraction will be ten seconds and 3 minutes after each set.
* WEEK 7-9: In clinics: Training diary will be overseen, and possible doubts will be clarified. Training protocol will be different according to PFM function assessed on week 6. MOS 0: 3 sets of 10 fast contraction and 3 sets of 5 contraction sustained for 3 seconds. The resting time after each contraction will be five seconds and after each set will be 2 minutes. MOS 1: 3 sets of 10 fast contraction and 3 sets of 6 contractions sustained for 4 seconds. The resting time after each contraction will be six seconds and 2 minutes after each set. MOS ≥ 2: 3 sets of 10 fast contraction and 3 sets of 10 contractions sustained for 6 seconds. The resting time after each contraction will be ten seconds and 3 minutes after each set. At home: Training protocol will be different according to PFM function assessed on week 6. MOS 0: 3 sets of 10 fast contraction and 3 sets of 5 contraction sustained for 3 seconds. Each set is supposed to be performed on a different position (i.e. supine, sitting and standing). The resting time after each contraction will be five seconds and after each set will be 2 minutes. MOS 1: 3 sets of 10 fast contraction and 3 sets of 6 contractions sustained for 4 seconds. Each set is supposed to be performed on a different position (i.e. supine, sitting and standing). The resting time after each contraction will be six seconds and 2 minutes after each set. MOS ≥ 2: 3 sets of 10 fast contraction and 3 sets of 10 contractions sustained for 6 seconds. Each set is supposed to be performed on a different position (i.e. supine, sitting and standing). The resting time after each contraction will be ten seconds and 3 minutes after each set.
* WEEK 10-12: In clinics: Training diary will be overseen, and possible doubts will be clarified. Training protocol will be different according to PFM function assessed on week 9. MOS 0: 3 sets of 10 fast contraction and 3 sets of 5 contraction sustained for 3 seconds. The resting time after each contraction will be five seconds and after each set will be 2 minutes. MOS 1: 3 sets of 10 fast contraction and 3 sets of 6 contractions sustained for 4 seconds. The resting time after each contraction will be six seconds and 2 minutes after each set. MOS ≥ 2: 3 sets of 10 fast contraction and 3 sets of 10 contractions sustained for 6 seconds. The resting time after each contraction will be ten seconds and 3 minutes after each set. At home: Training protocol will be different according to PFM function assessed on week 6. MOS 0: 3 sets of 10 fast contraction and 3 sets of 5 contraction sustained for 3 seconds. Each set is supposed to be performed on a different position (i.e. supine, sitting and standing). The resting time after each contraction will be five seconds and after each set will be 2 minutes. MOS 1: 3 sets of 10 fast contraction and 3 sets of 6 contractions sustained for 4 seconds. Each set is supposed to be performed on a different position (i.e. supine, sitting and standing). The resting time after each contraction will be six seconds and 2 minutes after each set. MOS ≥ 2: 3 sets of 10 fast contraction and 3 sets of 10 contractions sustained for 6 seconds. Each set is supposed to be performed on a different position (i.e. supine, sitting and standing). The resting time after each contraction will be ten seconds and 3 minutes after each set.

The two groups will receive a booklet and guidance to perform the training protocol at home on alternate days and a diary to register their adherence to the program. The guided protocol will be the same used during the supervised training on that specific week. Women will be oriented to choose the position to practice unsupervised sessions (i.e. supine,lateral, sitting and/or standing).

Eligibility criteria: Inclusion Criteria:

* Women aged 18 or over;
* Women referred to the physiotherapeutic treatment of the Lucy Montoro Rehabilitation Center (Ribeirão Preto Medical School) or the Women's Health Reference Center (MATER) for any pelvic floor dysfunction;
* Women unable to perform a PFM contraction (i.e. PFM function classified as 0 or 1 according to the modified oxford scale);
* Women with urinary incontinence (i.e ICIQ-UI-SF score ≥ 3)
* Agree to participate in the research by signing the informed consent form

It will not be included in this study:

* Women whose pelvic floor dysfunction has an associated neuropathy;
* Women with vaginal or urological symptoms of possible infections;
* Women with pelvic organs prolapse that makes it impossible to evaluate or conduct treatment (stage \> 2 according to Baden-Walker Scale);
* Pregnant women;
* Women with cognitive impairment.

Exclusion Criteria:

* Women who become pregnant while conducting the study
* Women with intolerance or pain that prevents the conduct of research protocols.

Primary outcomes:
measure: change in ability to perform a voluntary PFM contraction
timeFrame: At baseline, 3, 6, 9 and 12 weeks
Secondary outcomes:
measure: Urinary incontinence (UI)
timeFrame: baseline and 12 weeks
measure: self-perception of pelvic floor muscle (PFM) contraction
timeFrame: At baseline, 3, 6, 9 and 12 weeks
measure: adherence to treatment
timeFrame: weekly up to 12 weeks
measure: adverse effects
timeFrame: 12 weeks
measure: satisfaction with treatment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Universidade de São Paulo
state: SÃO Paulo
Study officials:
References: