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Completed

NCT Number: NCT03244397

Physical Therapy on Pelvic Organ Prolapse

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.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

25 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Physiotherapy in women´s health research group. University of Alcalà, Alcalà de Henares, Madrid, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Physical therapy + educational strategy

Other

See arm/group descriptions

Educational strategy

Behavioral

See arm/group descriptions

Primary outcomes

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

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

    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.

  2. 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)

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

    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.

Secondary outcomes

  1. Change in pelvic floor muscle strength assessed by perineal manometry

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

    Pelvic floor muscle strength will be assessed using perineal manometry. Three maximal voluntary pelvic floor muscle contractions will be performed, and the mean value will be used for analysis. Higher values indicate greater pelvic floor muscle strength.

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

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

    Pelvic floor muscle strength will be assessed by vaginal palpation using the Modified Oxford Scale, ranging from 0 (no contraction) to 5 (strong contraction). Higher scores indicate greater pelvic floor muscle strength.

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

    Time frame: Baseline, immediately post-intervention, 6 months, and 12 months post-intervention.

    Pelvic organ prolapse stage will be assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system. POP will be classified as stage 0, I, II, III, or IV according to the most distal portion of the prolapse relative to the hymen. Lower stages indicate less severe prolapse.

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

Effectiveness of Physical Therapy on Pelvic Organ Prolapse Stages I & II

Acronym: PT-POP

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Aug 9, 2017
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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