Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05194137 |
| Other study ID # |
32215720.0.0000.5440 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2022 |
| Est. completion date |
May 1, 2024 |
Study information
| Verified date |
December 2022 |
| Source |
University of Sao Paulo |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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).
