Biofeedback Versus Vaginal Palpation to Teach a Voluntary Pelvic Floor Muscle Contraction to Women Incapable of Performing it? A Non-inferiority Randomized Controled Trial

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.