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Pharmacological vs Surgical Treatment for Mixed Incontinence

Primary Purpose

Mixed Urinary Incontinence, Urinary Incontinence, Stress, Urinary Incontinence, Urge

Status

Unknown status

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

Tolterodine

tension free vaginal tape

About this trial

This is an interventional treatment trial for Mixed Urinary Incontinence focused on measuring overactive bladder, stress urinary incontinence, detrusor overactivity, urodynamics

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Patients must be female as this is a urogynaecology study.
An age of between 35 and 70 years. This takes into account that incontinence tends to prevail in women with advancing years. Younger women may be planning to start a family which precludes them from participating.
Clinical urodynamic evidence of mixed incontinence with prevalence of symptoms of stress incontinence assessed by means of a specific questionnaire and visual analog scale (VAS). The study is assessing the treatment of mixed incontinence and the patients will have to have evidence of this which is provided by their symptoms.
Candidates for corrective surgery of the component of sphincter defect with Ba < - 1 according to the International Continence Society (ICS) classification of genital prolapse.
Patients capable of filling in the micturition diary, the VAS, and the pathology specific quality of life questionnaire, the Kings Health Questionnaire. These form part of the continuing assessment of effectiveness of treatment.
Patients capable of understanding and signing an informed written consent form for participating in the trial. If patients are unable to give their consent for the procedures and investigations they cannot be ethically recruited.
Patients who accept not to give birth vaginally in the future, so as not to jeopardize the results of the surgical operation.

Exclusion Criteria:

Contraindications for using anti-cholinergic agents (urinary retention, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe ulcerative colitis, toxic megacolon). Anticholinergics form one group of the patients and inability to take these drugs therefore precludes them from participating.
Ascertained hypersensitivity to tolterodine or any of the excipients. For the above reason.
Presence of pathologies or conditions that in the Investigator's opinion make the patient unsuitable for inclusion.
Patients with urinary tract infections (UTI) during the run-in period.
Patients with recurrent urinary tract infections (> 5 in the past 12 months).
Patients with diagnosed interstitial cystitis.
These compromise the results obtained.
Patients with haematuria of uncertain origin. These patients need urgent investigation of these signs with procedures that are not included in the study.
Patients on treatment with anti-cholinergic agents of other drugs acting on detrusor instability. This will compromise the results of the study if for example these patients are randomised into the surgical group.
Patients on treatment with oestrogens, unless the therapy was commenced at least 2 months prior to inclusion in the study and follows a constant dosage.
Patients on diuretics. This affect their urinary behaviour.
Patients on concomitant treatment with potent CYP 34A inhibitors, such as macrolide antibiotics or antimycotic agents.
Patients who have undergone previous surgery on the distal urinary tract (with the exception of hysterectomy).
Patients who do not have adequate contraceptive cover or patients who are breast-feeding. For reasons of avoiding pregnancy during the study.

Sites / Locations

Demetri C Panayi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Tension Free Vaginal Tape

Tolterodine tartrate 4mg

Outcomes

Primary Outcome Measures

improvement in subjective and objective measures of urinary incontinence

Secondary Outcome Measures

assessment of pre-treatment predictors of success or failure of treatment

assessment of pre-treatment predictors of requirement for alternative treatment

Full Information

NCT ID

NCT00523068

First Posted

August 29, 2007

Last Updated

November 6, 2007

Sponsor

Imperial College London

1. Study Identification

Unique Protocol Identification Number

NCT00523068

Brief Title

Pharmacological vs Surgical Treatment for Mixed Incontinence

Official Title

Randomized Pilot Study on the Treatment of Mixed Urinary Incontinence: Pharmacological Treatment (Tolterodine SR) vs Surgery With Tension Free Vaginal Tape

Study Type

Interventional

2. Study Status

Record Verification Date

August 2007

Overall Recruitment Status

Unknown status

Study Start Date

September 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Imperial College London

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

In patients with symptoms of mixed incontinence (loss of urine associated with coughing/sneezing/laughing, and loss of urine associated with the strong urge to void), is surgical treatment with tension free vaginal tape or pharmacological treatment with tolterodine more effective? What are the parameters predictive of success or failure with either forms of treatment? What are the parameters predictive of the necessity for further treatment after primary treatment? Patients will be randomised to having surgical or pharmacological treatment for their mixed incontinence symptoms. They will be assessed subjectively and objectively pre-treatment and after treatment at intervals up to 3 months.

Detailed Description

The aim of the study is to compare the efficacy and effect on the patient subsequent to pharmacological treatment with single dose tolterodine compared to surgical treatment with TVT in patients with urodynamically demonstrated mixed urinary incontinence, but with prevailing symptoms of stress incontinence. Secondary aims are the identification of parameters predictive of success or failure for the two treatments (echography, duration of the symptoms) and the necessity for further treatment after the primary therapy. The primary objective is to reduce the number of incontinence episodes after treatment with either modality. The design will be randomisation of 40 patients, with 20 in the surgical group and 20 in the pharmacological treatment group. The patients must be female and aged between 35 and 70. They should not be intending to fall pregnant and be capable of completing a questionnaire about their incontinence symptoms and quality of life, a diary of their incontinence episodes and account of the passing of their urine, as well as be able to give informed consent to participate in the study. The study will last for approximately 12 months and will consist of 5 visits. At the first visit, the patient will be seen to verify their suitability for admission into the study, have baseline blood tests, and urine analysis, as well as urodynamic assessment. They will also be given a diary to fill out an account of their urine passing which they will be asked to complete for the course of 3 days prior to their next appointment. At the second appointment, the patient's diary will be collected and reviewed, a quality of life questionnaire will be completed, as well as an ultrasound scan performed to assess the thickness of the wall of their bladder. The patients will then be randomised into the pharmacological and surgical groups. Those in the surgical group will be put onto the waiting list for TVT (which they will have within 2 weeks of the second appointment), or commence treatment with tolterodine. 4 weeks after either treatment the patients are seen again and their symptoms are assessed and a second diary of the urinary behaviour (completed by the patient for the week prior to this visit) will be reviewed. On the final visit, which will be after 12 weeks of treatment, the patients undergo urodynamic testing, diary assessment, symptom assessment, a quality of life questionnaire is completed and an appraisal of the patient's satisfaction with their treatment is collected. The discussion of need for any further treatment will take place and at this stage the patient may then have their treatment changed to either the tolterodine or surgery depending on their symptoms. These patients will then be finally seen after six months to review their progress.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mixed Urinary Incontinence, Urinary Incontinence, Stress, Urinary Incontinence, Urge

Keywords

overactive bladder, stress urinary incontinence, detrusor overactivity, urodynamics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Tension Free Vaginal Tape

Arm Title

Arm Type

Active Comparator

Arm Description

Tolterodine tartrate 4mg

Intervention Type

Drug

Intervention Name(s)

Tolterodine

Other Intervention Name(s)

detrusitol XL

Intervention Type

Procedure

Intervention Name(s)

tension free vaginal tape

Primary Outcome Measure Information:

Title

improvement in subjective and objective measures of urinary incontinence

Time Frame

3 months

Secondary Outcome Measure Information:

Title

assessment of pre-treatment predictors of success or failure of treatment

Time Frame

3 months

Title

assessment of pre-treatment predictors of requirement for alternative treatment

Time Frame

3 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must be female as this is a urogynaecology study. An age of between 35 and 70 years. This takes into account that incontinence tends to prevail in women with advancing years. Younger women may be planning to start a family which precludes them from participating. Clinical urodynamic evidence of mixed incontinence with prevalence of symptoms of stress incontinence assessed by means of a specific questionnaire and visual analog scale (VAS). The study is assessing the treatment of mixed incontinence and the patients will have to have evidence of this which is provided by their symptoms. Candidates for corrective surgery of the component of sphincter defect with Ba < - 1 according to the International Continence Society (ICS) classification of genital prolapse. Patients capable of filling in the micturition diary, the VAS, and the pathology specific quality of life questionnaire, the Kings Health Questionnaire. These form part of the continuing assessment of effectiveness of treatment. Patients capable of understanding and signing an informed written consent form for participating in the trial. If patients are unable to give their consent for the procedures and investigations they cannot be ethically recruited. Patients who accept not to give birth vaginally in the future, so as not to jeopardize the results of the surgical operation. Exclusion Criteria: Contraindications for using anti-cholinergic agents (urinary retention, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe ulcerative colitis, toxic megacolon). Anticholinergics form one group of the patients and inability to take these drugs therefore precludes them from participating. Ascertained hypersensitivity to tolterodine or any of the excipients. For the above reason. Presence of pathologies or conditions that in the Investigator's opinion make the patient unsuitable for inclusion. Patients with urinary tract infections (UTI) during the run-in period. Patients with recurrent urinary tract infections (> 5 in the past 12 months). Patients with diagnosed interstitial cystitis. These compromise the results obtained. Patients with haematuria of uncertain origin. These patients need urgent investigation of these signs with procedures that are not included in the study. Patients on treatment with anti-cholinergic agents of other drugs acting on detrusor instability. This will compromise the results of the study if for example these patients are randomised into the surgical group. Patients on treatment with oestrogens, unless the therapy was commenced at least 2 months prior to inclusion in the study and follows a constant dosage. Patients on diuretics. This affect their urinary behaviour. Patients on concomitant treatment with potent CYP 34A inhibitors, such as macrolide antibiotics or antimycotic agents. Patients who have undergone previous surgery on the distal urinary tract (with the exception of hysterectomy). Patients who do not have adequate contraceptive cover or patients who are breast-feeding. For reasons of avoiding pregnancy during the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Demetri C Panayi, BSc MRCOG

Phone

02078861016

d.panayi@imperial.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vikram Khullar

Organizational Affiliation

Imperial College London

Official's Role

Study Director

Facility Information:

Facility Name

Demetri C Panayi

City

London

ZIP/Postal Code

sw18 4qr

Country

United Kingdom

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Demetri C Panayi, BSc MRCOG

Phone

02078861016

d.panayi@imperial.ac.uk

12. IPD Sharing Statement

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Pharmacological vs Surgical Treatment for Mixed Incontinence

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