Physical Therapy on Pelvic Organ Prolapse

NCT03244397 | Completed DMC

• 1 other identifier: 21/2012
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

OBJECTIVE: To evaluate the effectiveness of an individualized pelvic floor physiotherapy programme combined with lifestyle education compared with lifestyle education alone in women with stage I or II pelvic organ prolapse (POP). DESIGN: Randomized controlled clinical trial with blinded outcome assessment. A total of 120 women were randomly allocated to an experimental group receiving an individualized pelvic floor physiotherapy programme plus lifestyle education or to a control group receiving lifestyle education alone. Assessments were performed at baseline, immediately after the intervention, and at 3, 6, and 12 months. PRIMARY OUTCOMES: Pelvic floor symptoms and their impact on daily life, assessed using the Pelvic Floor Distress Inventory-20 (PFDI-20) and Pelvic Floor Impact Questionnaire-7 (PFIQ-7). SECONDARY OUTCOMES: Anatomical pelvic organ prolapse stage and pelvic floor muscle strength assessed by vaginal palpation using the Modified Oxford Scale and by perineal manometry. DATA ANALYSIS: Treatment effectiveness will be evaluated by comparing changes over time between groups throughout the 12-month follow-up.

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic organ prolapse; Pelvic floor muscle training; Physiotherapy; Pelvic floor rehabilitation; Conservative treatment; Women

Outcome Measures

Primary Outcomes (2)

• Change in pelvic floor symptom distress assessed with the Spanish version of the Pelvic Floor Distress Inventory-20 (PFDI-20)

  The PFDI-20 is a 20-item patient-reported outcome measure assessing symptom distress related to pelvic floor disorders. It comprises three subscales: the Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6), Colorectal-Anal Distress Inventory-8 (CRADI-8), and Urinary Distress Inventory-6 (UDI-6). Each subscale is scored from 0 to 100, with higher scores indicating greater symptom distress. The total PFDI-20 score ranges from 0 to 300, with higher scores indicating greater overall pelvic floor symptom distress.

  5 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, and 12 months after the intervention.

• Change in the impact of pelvic floor symptoms on daily activities assessed with the Spanish version of the Pelvic Floor Impact Questionnaire-7 (PFIQ-7)

  The PFIQ-7 is a 21-item patient-reported outcome measure comprising three 7-item subscales: the Urinary Impact Questionnaire-7 (UIQ-7), Pelvic Organ Prolapse Impact Questionnaire-7 (POPIQ-7), and Colorectal-Anal Impact Questionnaire-7 (CRAIQ-7). Each subscale is scored from 0 to 100, with higher scores indicating greater impact of pelvic floor symptoms on daily activities. The total PFIQ-7 score ranges from 0 to 300, with higher scores indicating greater overall impact.

  5 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, and 12 months after the intervention.

Secondary Outcomes (3)

• Change in pelvic floor muscle strength assessed by perineal manometry

  5 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, and 12 months after the intervention.

• Change in pelvic floor muscle strength assessed by vaginal palpation using the Modified Oxford Scale

  5 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, and 12 months after the intervention.

• Change in pelvic organ prolapse stage assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system

  Baseline, immediately post-intervention, 6 months, and 12 months post-intervention.

Study Arms (2)

Physiotherapy group

EXPERIMENTAL

Participants allocated to this group will receive an individualized pelvic floor physiotherapy programme consisting of 16 sessions (45-50 minutes per session), delivered twice weekly for 8 weeks, in addition to the educational intervention described for the control group. The physiotherapy programme will include pelvic floor muscle training (PFMT), individualized according to pelvic floor muscle function assessed by vaginal palpation, biofeedback-assisted exercises, and hypopressive exercises. From the eighth session onwards, participants will also be instructed to perform the prescribed exercises daily at home.

Other: Physical therapy + educational strategy

Control group

ACTIVE COMPARATOR

Participants allocated to this group will receive an educational intervention consisting of six weekly sessions (40-45 minutes per session). The programme will include education on pelvic floor anatomy and pelvic organ function using printed materials and anatomical models, together with advice on modifiable lifestyle factors associated with pelvic floor symptoms, including weight management, heavy lifting, high-impact activities, constipation, smoking, and caffeine intake. Participants will also receive advice on appropriate toileting habits and will be taught the Knack manoeuvre to be performed before and during activities that increase intra-abdominal pressure.

Behavioral: Educational strategy

Interventions

Physical therapy + educational strategy OTHER

See arm/group descriptions

Physiotherapy group

Educational strategy BEHAVIORAL

See arm/group descriptions

Control group

Eligibility Criteria

• Age: 25 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with stage I or II pelvic organ prolapse (POP), as determined using the Pelvic Organ Prolapse Quantification (POP-Q) system.

You may not qualify if:

• Stage III or IV POP according to the POP-Q system.
• Previous conservative treatment or surgery for POP. Neurological, gynecological, or urological conditions that could interfere with the intervention or outcome assessment.
• Urinary tract infection or recurrent hematuria.
• Current pregnancy or vaginal delivery within the previous 6 months.
• Cognitive or language limitations that could prevent participants from understanding the study procedures, providing informed consent, completing the study questionnaires, or adequately participating in the intervention.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (2)

Physiotherapy in women´s health research group. University of Alcalà

Alcalà de Henares, Madrid, 28871, Spain

Location

University of Alcalá. FPSM research group. HUPA

Alcalá de Henares, Madrid, 28805, Spain

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two groups: Experimental group and Control group

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: August 9, 2017
• Study Start: August 8, 2017
• Primary Completion: December 10, 2020
• Study Completion: December 28, 2021
• Last Updated: September 1, 2026

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)