Pelvic muscle training associated with the use of pessaries in the treatment of pelvic organ fall: Randomized clinical trial

Pelvic floor muscle training associated with the use of pessaries in the treatment of pelvic organ prolapse: Randomized clinical trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

REBEC

Registry ID

RBR-8qnmdpm

Enrollment

Unknown

Registered

2022-04-28

Start date

2022-05-16

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic organ prolapse.

Interventions

Participants will be randomized to two different groups. Group 1 (experimental group): 61 women will use the pessary associated with the TMAP (Pelvic floor muscle training) and Group 2 (comparison gro

E02.760.169.063.500.387.875

E07.858.499

Eligibility

Sex/Gender

Female

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Women with pelvic organ prolapse; staging equal to or greater than two; present intact vaginal mucosa and prolapsed region; are without signs and / or symptoms of urinary tract infection; without vaginal infections

Exclusion criteria

Exclusion criteria: Women whose insertion of the pessary was not successful; women with a modified Oxford score less than two

Design outcomes

Primary

Measure	Time frame
A reduction in prolapse is expected, evaluated by Pelvic Organ Prolapse Quantification System (POP-Q): measurements in centimeters evaluated at the first medical consultation for the evaluation of women with Pelvic Organ Prolapse and after the last evaluation of the Pelvic Floor Muscle Training (12th week of training).	—

Secondary

Measure	Time frame
Assess quality of life: in the first week (week 1) using the Quality of Life Questionnaire - Prolapse, and after the end of the interventions, in the 36th week of follow-up. It is expected that it has a low score, which indicates a good quality of life.;To evaluate the performance of the Pelvic Floor Muscles by the modified Oxford scale and by the Peritron®, evaluated in the first consultation for evaluation of the woman with therapeutic indication of the vaginal pessary and in the last evaluation of the Training of the Pelvic Floor Muscles (12th week of training). An increase of at least one level on the Oxford scale and an increase in the performance of the Pelvic Floor Muscles is expected.;Assess sexual function through the score of the Female Sexual Function Index (FSFI) questionnaire, verified at the first consultation to assess women with therapeutic indication for a vaginal pessary and after the end of the interventions at the 36th week. Improvement in sexual function of at least one level above baseline is expected.;Assess adherence to the proposed treatment. A minimum of 70% adherence to treatment is expected.;Evaluate a complaint of Urinary Incontinence and/or Anal Incontinence: It is expected that it will present improvement in urinary and fecal symptoms.;Evaluate pessary number: Evaluated at the insertion visit and at the 36th week of follow-up. It is expected to reduce the ideal pessary number by at least one number.	—

Measure

Time frame

Assess quality of life: in the first week (week 1) using the Quality of Life Questionnaire - Prolapse, and after the end of the interventions, in the 36th week of follow-up. It is expected that it has a low score, which indicates a good quality of life.;To evaluate the performance of the Pelvic Floor Muscles by the modified Oxford scale and by the Peritron®, evaluated in the first consultation for evaluation of the woman with therapeutic indication of the vaginal pessary and in the last evaluation of the Training of the Pelvic Floor Muscles (12th week of training). An increase of at least one level on the Oxford scale and an increase in the performance of the Pelvic Floor Muscles is expected.;Assess sexual function through the score of the Female Sexual Function Index (FSFI) questionnaire, verified at the first consultation to assess women with therapeutic indication for a vaginal pessary and after the end of the interventions at the 36th week. Improvement in sexual function of at least one level above baseline is expected.;Assess adherence to the proposed treatment. A minimum of 70% adherence to treatment is expected.;Evaluate a complaint of Urinary Incontinence and/or Anal Incontinence: It is expected that it will present improvement in urinary and fecal symptoms.;Evaluate pessary number: Evaluated at the insertion visit and at the 36th week of follow-up. It is expected to reduce the ideal pessary number by at least one number.

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Countries

Brazil

Contacts

Public ContactAngela Silva

Universidade Estadual de Campinas

angelafesi@yahoo.com.br+55-(35)-988161174

Outcome results

None listed

Source: REBEC (via WHO ICTRP)